CLINICAL RESEARCH NEWS AND GUIDELINES ARCHIVES

12

Feb 18

New Alzheimer’s Drug Falls Short on Efficacy

New Alzheimer’s Drug Falls Short on Efficacy New England Journal of Medicine (NEJM) recently published reports claiming that solanezumab, a...

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12

Feb 18

New partnership towards Parkinson’s disease Research

New partnership towards Parkinson’s disease Research A new partnership is in pipeline between the National Institutes of Health (NIH), government,...

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12

Feb 18

Draft Guidelines on Audio-Visual Recording by Health Ministry

Draft Guidelines on Audio-Visual Recording by Health Ministry Union health ministry in order to strengthen clinical research in India has...

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12

Feb 18

Patient Enrollment in Phase 4 trial of H.P.Acthar gel for Pulmonary Sarcoidosis Begins by Mallinckrodt.

Patient Enrollment in Phase 4 trial of H.P.Acthar gel for Pulmonary Sarcoidosis Begins by Mallinckrodt. A global pharmaceutical company, Mallinckrodt...

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7

Jul 17

A Personalized Cancer Vaccine Proves Breakthrough Innovation

A Personalized Cancer Vaccine Proves Breakthrough Innovation Lately scientists are working towards developing personalized vaccines which are designed to help...

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7

Jul 17

Flawed Study Designs in Clinical Trial Study leads to Confounding End-Points

Flawed Study Designs in Clinical Trial Study leads to Confounding End-Points Director, FDA John Whyte stated in a research study...

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7

Jul 17

Novel Innovation in Remote Collection of Clinical data

Novel Innovation in Remote Collection of Clinical data The CRO PAREXEL announced the launch of its patient sensor solution, a...

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7

Jul 17

European & Developing Countries Clinical Trials Partnership (EDCTP) 2017

European & Developing Countries Clinical Trials Partnership (EDCTP) 2017 The EDCTP launches 10 calls for requests for proposals to support...

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12

May 17

FDAs eCTD submission

May 2017, Deadline for FDAs eCTD submission: a Technical Modus Operandi Starting with May 5, 2017, all the pharmaceutical, biologic...

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13

Jan 17

Novel therapy for Post Operative Pain

Novel therapy for Post Operative Pain Heron Therapeutics Inc published a report from initial data from mid stage trial on...

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13

Jan 17

Oncology Clinical Trials May Benefit Patients Who Typically Don’t Qualify

Oncology Clinical Trials May Benefit Patients Who Typically Don't Qualify Many cancer patients due to co-morbidities and other health problems...

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4

Jan 17

Lilly’s Solanezumab failed in Phase III trial

Lilly’s Solanezumab failed in Phase III trial Eli Lilly announced in a joint statement following failure of phase III clinical...

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4

Jan 17

A novel approach to treat Prostate cancer

A novel approach to treat Prostate cancer In a phase III clinical trial, light therapy is believed to be effective...

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4

Jan 17

Process development to Capture Global CRA Shortage

Process development to Capture Global CRA Shortage A recent survey by CNN money opined that Clinical Research Associate (CRA) is one...

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24

Nov 16

EMA proposed revision to its 2007 guideline on first-in-human clinical trials

EMA proposed revision to its 2007 guideline on first-in-human clinical trials The European Medicines Agency (EMA), in cooperation with the European Commission...

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24

Nov 16

First clinical trial to treat Wolfram syndrome launched by researchers

First clinical trial to treat Wolfram syndrome launched by researchers Wolfram syndrome affects about one in every 500,000 people worldwide....

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24

Nov 16

Clinical trials begin for Army developed Zika Vaccine

Clinical trials begin for Army developed Zika Vaccine A clinical trial began at the Walter Reed Army Institute of Research...

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24

Nov 16

Sanofi & Novartis AG are the worst companies in reporting clinical trial data

Sanofi & Novartis AG are the worst companies in reporting clinical trial data According to the trialstracker system, Sanofi and...

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24

Nov 16

30 drug applications rejected by China due to data fabrication

30 drug applications rejected by China due to data fabrication China’s Food and Drug Administration (CFDA) has rejected 30 new...

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24

Nov 16

The European Medicines Agency published data on two recently approved drugs as an effort to make clinical reports publicly available

The European Medicines Agency published data on two recently approved drugs as an effort to make clinical reports publicly available...

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24

Nov 16

Milestone achieved in human clinical trial through new Alzheimer’s Drug

Milestone achieved in human clinical trial through new Alzheimer’s Drug A brain plaque inhibitor developed by Merck is now being...

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11

Nov 16

Patent filed for Zika Vaccine candidates by Indian firm , Bharat Biotech

Patent filed for Zika Vaccine candidates by Indian firm , Bharat Biotech Global patent of two vaccine candidates - a...

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11

Nov 16

Decision for drug dose in clinical trials made easy through a mathematical model

Decision for drug dose in clinical trials made easy through a mathematical model A mathematical model may offer a valuable...

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11

Nov 16

Expansion of access to clinical trial data by Daiichi Sankyo

Expansion of access to clinical trial data by Daiichi Sankyo Daiichi Sankyo Group is dedicated to the creation and supply...

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11

Nov 16

Limited Participation of women in HIV clinical trials

Limited Participation of women in HIV clinical trials According to the researchers less than a quarter of people taking part...

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11

Nov 16

Pregnant women advised not to travel to Zika affected areas by WHO

Pregnant women advised not to travel to Zika affected areas by WHO As Zika vaccines are almost 18 months far...

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21

Oct 16

80 % fabricated data found in case of Chinese clinical trials by China’s FDA

80 % fabricated data found in case of Chinese clinical trials by China’s FDA China's food and drug regulator recently...

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21

Oct 16

First automated insulin delivery device for type I diabetes approved by FDA

First automated insulin delivery device for type I diabetes approved by FDA The human pancreas naturally supplies a low, continuous...

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21

Oct 16

New hope for lung transplantation offered by world’s first clinical trial

New hope for lung transplantation offered by world’s first clinical trial Lungs have the highest rate of rejection compared to...

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21

Oct 16

Majority of adverse events remain unpublished in clinical trials

Majority of adverse events remain unpublished in clinical trials According to PLoS Medicine, a lower & smaller range of adverse...

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21

Oct 16

Increase in unethical clinical trials in Pakistan due to government’s indiscretion

Increase in unethical clinical trials in Pakistan due to government’s indiscretion Over 600 pharmaceutical companies are making huge profits in...

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21

Oct 16

Government planning to fast-track approvals for clinical trials

Government planning to fast-track approvals for clinical trials The central drug regulator plans to fast track the approval process for...

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21

Oct 16

Waiver given to conduct of phase III trials for drugs by the government

Waiver given to conduct of phase III trials for drugs by the government According to the Drug Controller General of...

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21

Oct 16

Ayurvedic drug for dengue in advanced stages of clinical trials

Ayurvedic drug for dengue in advanced stages of clinical trials Clinical trials for Ayurvedic drug for dengue, jointly being carried...

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23

Sep 16

New rules released to stricken the clinical trial transparency by United States

New rules released to stricken the clinical trial transparency by United States US Department of Health and Human Services (HHS)...

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23

Sep 16

New study to combat HIV with antibodies

New study to combat HIV with antibodies A clinical trial have been launched by the researchers in United States along...

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23

Sep 16

Dengue vaccine unlikely to be introduced in India this year due to limited data

Dengue vaccine unlikely to be introduced in India this year due to limited data The licensed vaccine, Dengvaxia, has became...

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23

Sep 16

Usage of digital tools in clinical trials-An area of concern

Usage of digital tools in clinical trials-An area of concern According to a report by Validic/BioPharma Dive, usage of digital...

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23

Sep 16

Phase 2b trial initiated for non-hormonal PCOS (Polycystic Ovarian Syndrome) drug

Phase 2b trial initiated for non-hormonal PCOS (Polycystic Ovarian Syndrome) drug Phase 2b clinical trial for a non-hormonal therapy, MLE4901,...

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9

Sep 16

A promising vaccine against Chickungunya in clinical trial Phase 2

A promising vaccine against Chickungunya in clinical trial Phase 2 Chikungunya fever is a viral infection transmitted by mosquitoes. It...

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9

Sep 16

The number of cardiovascular drugs being studied in clinical trials is very low

The number of cardiovascular drugs being studied in clinical trials is very low According to research published in JACC: Basic...

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9

Sep 16

A study revealed that Diabetic Drug Metformin can help to prevent heart disease

A study revealed that Diabetic Drug Metformin can help to prevent heart disease Metformin is an inexpensive treatment that is...

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9

Sep 16

Dengue vaccine to be developed by United States to start clinical trials

Dengue vaccine to be developed by United States to start clinical trials According to the data provided by National Vector...

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9

Sep 16

A study has revealed that TPP can have serious implications for pharma industry

A study has revealed that TPP can have serious implications for pharma industry Trans Pacific Partnership Agreement (TPP) is a...

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27

Aug 16

Center’s decision of not limiting the number of clinical trials undertaken by investigator will enhance its overall quality

Center’s decision of not limiting the number of clinical trials undertaken by investigator will enhance its overall quality Previously CDSCO...

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27

Aug 16

Draft trial guidelines released by ICMR for AYUSH (Ayurveda, Yoga, Unani, Siddha and Homeopathy) schools

Draft trial guidelines released by ICMR for AYUSH (Ayurveda, Yoga, Unani, Siddha and Homeopathy) schools ICMR (Indian Council of Medical...

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27

Aug 16

Minorities and the poor still not equally represented in clinical research

Minorities and the poor still not equally represented in clinical research Different racial and ethnic groups experience disease and respond...

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27

Aug 16

Digital health technologies are providing pharma companies with detailed insights into the medication-taking behaviors of trial participants

Digital health technologies are providing pharma companies with detailed insights into the medication-taking behaviors of trial participants In trials that...

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27

Aug 16

Three ways through which the digital health technology is changing medication adherence in clinical trials

Three ways through which the digital health technology is changing medication adherence in clinical trials Ensure medication is taken, and...

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11

Aug 16

New rules for clinical trials and consent laid down by ICMR

New rules for clinical trials and consent laid down by ICMR ICMR has recently released draft National Ethical Guidelines for...

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11

Aug 16

Proposals to revise guidance on first-in-human clinical trials

Proposals to revise guidance on first-in-human clinical trials The European Medicines Agency (EMA), in cooperation with the European Commission and...

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11

Aug 16

Hepatitis C Clinical Trial Guideline updated by European Regulators

Hepatitis C Clinical Trial Guideline updated by European Regulators The European Medicines Agency has initiated the updation of its guideline...

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11

Aug 16

Remote monitoring app being tested for arthritis in clinical trial

Remote monitoring app being tested for arthritis in clinical trial According to ClinicalTrials.gov, Pfizer along with Brigham and Women's Hospital...

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11

Aug 16

Many of the Clinical Trials not listed at Clinical Study Data repository

Many of the Clinical Trials not listed at Clinical Study Data repository According to a research letter published in the...

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11

Aug 16

Approval to an over-the-counter retinoid drug for acne given by US FDA which offers new hope for acne sufferers

Approval to an over-the-counter retinoid drug for acne given by US FDA which offers new hope for acne sufferers The...

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11

Aug 16

A new clinical trial matching tool launched by JDRF and TrialReach to solve critical challenges in Diabetes Research

A new clinical trial matching tool launched by JDRF and TrialReach to solve critical challenges in Diabetes Research JDRF is...

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11

Aug 16

First ever human gene-editing trial to be conducted by Chinese scientists

First ever human gene-editing trial to be conducted by Chinese scientists Chinese scientists will become the first in the world...

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11

Aug 16

Clinical research on Hepatitis is at the back front in India according to ISCR

Clinical research on Hepatitis is at the back front in India according to ISCR According to Indian Society for Clinical...

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7

Jul 16

According to a study, the effectiveness of malaria vaccine reduces over several years

According to a study, the effectiveness of malaria vaccine reduces over several years There is currently no vaccine against malaria...

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7

Jul 16

The Medicines and Healthcare products Regulatory Agency (MHRA) to halt approvals for clinical trials conducted by India’s Quest Life Sciences

The Medicines and Healthcare products Regulatory Agency (MHRA) to halt approvals for clinical trials conducted by India's Quest Life Sciences...

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7

Jul 16

Virginia Commonwealth University (VCU) launched a new website to help researchers easily find the clinical participants they need

Virginia Commonwealth University (VCU) launched a new website to help researchers easily find the clinical participants they need VCU’s C....

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7

Jul 16

INOpulse Devices tested for pulmonary arterial hypertension (PAH) disorders in Clinical Trials

INOpulse Devices tested for pulmonary arterial hypertension (PAH) disorders in Clinical Trials In PAH patients, arteries that transport blood from the...

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7

Jul 16

Latest anti-aging drug, Nicotinamide mononucleotide (NMN) to be tested in humans

Latest anti-aging drug, Nicotinamide mononucleotide (NMN) to be tested in humans Nicotinamide mononucleotide (NMN) has been shown to slow the...

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23

Jun 16

New Drug (Ixekizumab) proved effective in treating psoriasis completely in clinical trials

New Drug (Ixekizumab) proved effective in treating psoriasis completely in clinical trials Psoriasis is an immune-mediated inflammatory disease that causes...

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23

Jun 16

Multi-centric trial to test a promising new treatment for chronic cough

Multi-centric trial to test a promising new treatment for chronic cough A cough is considered to be chronic when a...

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23

Jun 16

Draft guidance released by FDA on reporting of age, race and ethnic group data and their evaluation for device clinical studies

Draft guidance released by FDA on reporting of age, race and ethnic group data and their evaluation for device clinical...

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23

Jun 16

Experimental Zika vaccine approved for clinical trials for the first time by USFDA

Experimental Zika vaccine approved for clinical trials for the first time by USFDA The US Food and Drug administration has...

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23

Jun 16

Research from ICON shows that many pharmaceutical and clinical research organizations (CROs) support the use of a ‘Bring Your Own Device’ (BYOD) approach in clinical studies

Research from ICON shows that many pharmaceutical and clinical research organizations (CROs) support the use of a ‘Bring Your Own...

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23

Jun 16

New Effort being taken by Green Circle Health and Integrated Clinical Solutions to make patient reporting automatic for clinical trials

New Effort being taken by Green Circle Health and Integrated Clinical Solutions to make patient reporting automatic for clinical trials...

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9

Jun 16

Two new clinical trial recruitment methods introduced to streamline the process of matching patients with clinical trials

Two new clinical trial recruitment methods introduced to streamline the process of matching patients with clinical trials About two-thirds of...

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9

Jun 16

Four New Public Consultations on Clinical Trials by European Commission

Four New Public Consultations on Clinical Trials by European Commission European commission has released four new public consultations on clinical...

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9

Jun 16

Clinical trial opens new pathways for pharmacological therapy in Down’s syndrome

Clinical trial opens new pathways for pharmacological therapy in Down's syndrome According to the World Health Organization, Down's syndrome affects...

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9

Jun 16

In-Home Clinical Devices lead to improvement in clinical trial outcomes and efficiency

In-Home Clinical Devices lead to improvement in clinical trial outcomes and efficiency Clinical devices are instruments, implements or machines intended...

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9

Jun 16

Pfizer’s breast cancer drug given waiver for clinical trials

Pfizer’s breast cancer drug given waiver for clinical trials A drug named Palbociclib which significantly increases the rate of surviving...

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12

May 16

Patients are exposed to risks without getting benefits in case of failure to publish trial results

Patients are exposed to risks without getting benefits in case of failure to publish trial results Although the publication of...

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12

May 16

Women unnecessarily excluded from Type 2 Diabetes Drug trials

Women unnecessarily excluded from Type 2 Diabetes Drug trials According to the researchers, women who are pregnant, or breastfeeding or...

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12

May 16

Treatment of Parkinson’s disease through stem cell therapy being tried through clinical trials

Treatment of Parkinson’s disease through stem cell therapy being tried through clinical trials Stem cells have enormous promise in regenerative...

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12

May 16

Phase 3 clinical trials to treat psoriasis conducted by Sun Pharmaceuticals showed positive results

Phase 3 clinical trials to treat psoriasis conducted by Sun Pharmaceuticals showed positive results Results of two phase 3 clinical...

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12

May 16

Unprecedented protection in clinical trial proved with Sanaria’s Malaria Vaccine

Unprecedented protection in clinical trial proved with Sanaria’s Malaria Vaccine Results of a clinical trial of Sanaria® PfSPZ (Plasmodium falciparum...

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28

Apr 16

Clinical Study Data Manipulation observed at Mumbai Based Alkem Laboratories by EMA

Clinical Study Data Manipulation observed at Mumbai Based Alkem Laboratories by EMA While reviewing some of the drugs following clinical...

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28

Apr 16

The US National Institutes of Health (NIH) has suspended clinical trials at two of its manufacturing facilities after discovering contamination risk

The US National Institutes of Health (NIH) has suspended clinical trials at two of its manufacturing facilities after discovering contamination...

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28

Apr 16

Results published on clinical trials for experimental Ebola drug

Results published on clinical trials for experimental Ebola drug Results of the Wellcome Trust funded trial of the experimental anti-Ebola...

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28

Apr 16

Decision on Drug implant soon to be taken by FDA

Decision on Drug implant soon to be taken by FDA The U.S. Food and Drug Administration is expected to finally...

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8

Apr 16

Draft Streamlined Clinical Trial Protocol Template released by NIH in Collaboration with FDA

Draft Streamlined Clinical Trial Protocol Template released by NIH in Collaboration with FDA To increase the efficiency of clinical trial...

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8

Apr 16

Dengue Vaccine made by USA found to be 100 % effective in small study

Dengue Vaccine made by USA found to be 100 % effective in small study Dengue, found in the world's tropical...

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8

Apr 16

New Draft Guidance Published By EMA (The European Medicines Agency) on Human Clinical Trials for Cancer Drugs

New Draft Guidance Published By EMA (The European Medicines Agency) on Human Clinical Trials for Cancer Drugs The European Medicines...

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8

Apr 16

AllTrials campaign for clinical trial transparency joined by American Medical Association (AMA)

AllTrials campaign for clinical trial transparency joined by American Medical Association (AMA) Enhanced clinical trial transparency and the efforts of...

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31

Mar 16

No added benefit of using four TB drugs was found to save people with advanced HIV/AIDS according to a Clinical Study

No added benefit of using four TB drugs was found to save people with advanced HIV/AIDS according to a Clinical...

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17

Mar 16

Steps for patient safety during clinical trials being taken by the government

Steps for patient safety during clinical trials being taken by the government Mandatory provisions have been made to ensure patient...

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17

Mar 16

Clinical Trials on Promising Malaria Drug

Clinical Trials on Promising Malaria Drug Malaria killed about 440,000 people mostly young children last year, but a new drug...

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17

Mar 16

Hope for treatment of alcoholism through new drug

Hope for treatment of alcoholism through new drug Alcohol use disorder affects nearly 16.6 million people in the United States...

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17

Mar 16

Drug dosing to be done cautiously after fatal French drug trial urged by experts

Drug dosing to be done cautiously after fatal French drug trial urged by experts The volunteer died and five others...

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17

Mar 16

Clinical trial deaths prompt safety warning from Australian authorities on cancer drug Zydelig

 Clinical trial deaths prompt safety warning from Australian authorities on cancer drug Zydelig Zydelig was prescribed to patients with rare...

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3

Mar 16

Norms on clinical trials to be made easy by DCGI

Norms on clinical trials to be made easy by DCGI The clinical trials in India suffered a setback for the...

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3

Mar 16

Many Clinical Trials result take years to publish

Many Clinical Trials result take years to publish According to a new research, Medical researchers conducting the majority of clinical...

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3

Mar 16

Expansion of INC Research Partnership With Society for Clinical Research Sites to Enhance Site Sustainability on a Global Basis

Expansion of INC Research Partnership With Society for Clinical Research Sites to Enhance Site Sustainability on a Global Basis INC...

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3

Mar 16

Positive clinical trial results by Potential Ebola Drug

Positive clinical trial results by Potential Ebola Drug A biotechnology partnership aimed at treating the Ebola virus revealed that it...

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3

Mar 16

Phase 2 clinical trial shows promiseto treat rare hereditary muscle disease

Phase 2 clinical trial shows promiseto treat rare hereditary muscle disease Researchers present the first clinical study that provides evidence...

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19

Feb 16

Patent filed for Zika Vaccine candidates by Indian firm , Bharat Biotech

Patent filed for Zika Vaccine candidates by Indian firm , Bharat Biotech Global patent of two vaccine candidates - a...

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19

Feb 16

Decision for drug dose in clinical trials made easy through a mathematical model

Decision for drug dose in clinical trials made easy through a mathematical model A mathematical model may offer a valuable...

Read More

19

Feb 16

Expansion of access to clinical trial data by Daiichi Sankyo

Expansion of access to clinical trial data by Daiichi Sankyo Daiichi Sankyo Group is dedicated to the creation and supply...

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19

Feb 16

Limited Participation of women in HIV clinical trials

Limited Participation of women in HIV clinical trials According to the researchers less than a quarter of people taking part...

Read More

19

Feb 16

Pregnant women advised not to travel to Zika affected areas by WHO

Pregnant women advised not to travel to Zika affected areas by WHO As Zika vaccines are almost 18 months far...

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4

Feb 16

Design of Fatal French Clinical Trial questioned by researchers

Design of Fatal French Clinical Trial questioned by researchers Scientists had concerns over the design of a French drug trial that...

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4

Feb 16

Portal Released by Big Pharma Consortium for clinical trial investigators

Portal Released by Big Pharma Consortium  for clinical trial investigators Big Pharma Consortium ”TransCelerate BioPharma” which is an R& D...

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4

Feb 16

The government to fix regulation of clinical trials

The government to fix regulation of clinical trials According to a study by Pugatch Consilium, a consultancy research firm trial...

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4

Feb 16

Efforts for ZIKA Vaccine by Sanofi Pasteur

Efforts for ZIKA Vaccine by Sanofi Pasteur Zika is amosquito-borne virus, which has been linked to birth defects and is...

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4

Feb 16

Phase 1 clinical trial for Ebola vaccinelaunched by Profectus BioSciences

Phase 1 clinical trial for Ebola vaccinelaunched by Profectus BioSciences Profectus BioSciences Inc., a clinical-stage vaccine company that creates vaccines...

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21

Jan 16

Low accrual rates for clinical trials as predicted by a model

Low accrual rates for clinical trials as predicted by a model Researchers have identified several trial-level and treatment-related characteristics of...

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21

Jan 16

Relaxation in Clinical trial rules to aid research

Relaxation in Clinical trial rules to aid research The Indian government is in the process of relaxing down clinical trial...

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21

Jan 16

Large-scale clinical trials for Sanofi’s dengue vaccine

Large-scale clinical trials for Sanofi's dengue vaccine An expert consultative committee of the Indian drug regulatory agency has given approval...

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21

Jan 16

Finding Options in clinical trials made easier for Pancreatic Cancer Patients

Finding Options in clinical trials made easier for Pancreatic Cancer Patients Patients and their loved ones can find pancreatic cancer...

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21

Jan 16

Clinical Trial Disaster In France

Clinical Trial Disaster In France One person is brain dead and five more have been hospitalized after a phase I...

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11

Jan 16

H7N9 Influenza Vaccine Promising in Clinical Trial

H7N9 Influenza Vaccine Promising in Clinical Trial H7N9 influenza emerged in spring 2013 in China, primarily affecting people who have...

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11

Jan 16

Healthy growth rate increasing in the global clinical trials cold chain logistics market

Healthy growth rate increasing in the global clinical trials cold chain logistics market Globalization and increasing investment in clinical trials...

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11

Jan 16

World’s first dengue fever vaccine after 20 years of research approved by Mexico

World’s first dengue fever vaccine after 20 years of research approved by Mexico The first vaccine against dengue fever recently...

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11

Jan 16

Strengthening of Drug Trial Inspections by China

Strengthening of Drug Trial Inspections by China China is the world's second-biggest drugs market behind the United States and is...

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11

Jan 16

Approval for the manufacture of three antiviral drugs without clinical trials

Approval for the manufacture of three antiviral drugs without clinical trials The National Centre for Disease Control (NCDC), Delhi, has...

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11

Jan 16

Long term clinical trial of artificial pancreas for Type I diabetes patients

Long term clinical trial of artificial pancreas for Type I diabetes patients Researchers will soon undertake one of the largest-ever...

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11

Dec 15

Trial of malaria vaccine recommended by WHO group

Trial of malaria vaccine recommended by WHO group To understand the best use a vaccine that protects young children against...

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11

Dec 15

Opening for Volunteers in phase 2 trial of chikungunya sponsored by NIH

Opening for Volunteers in phase 2 trial of chikungunya sponsored by NIH Testing of an experimental vaccine to protect against...

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11

Dec 15

Using Electronic Health Records will lead to faster development of new drugs

Using Electronic Health Records will lead to faster development of new drugs A cost-benefit study have established that the revolutionary...

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11

Dec 15

Phase 1b clinical trial with antidepressant drug proved to be safe and effective

Phase 1b clinical trial with antidepressant drug proved to be safe and effective Today's antidepressant drugs provide inadequate treatment to...

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11

Dec 15

IMPACT® Express Clinical Trial Management System launched by PAREXEL

IMPACT® Express Clinical Trial Management System launched by PAREXEL The most expensive component of the drug development process is clinical...

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1

Dec 15

ASSOCHAM urged government to bring change in compensation criteria in clinical trials

ASSOCHAM urged government to bring change in compensation criteria in clinical trials In a note submitted to the Health and...

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1

Dec 15

New Online submission system launched by CDSCO for clinical trials

New Online submission system launched by CDSCO for clinical trials New online submission system for clinical trials has been launched...

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1

Dec 15

GVK Given clean chit by government panel in drug clinical trials

GVK Given clean chit by government panel in drug clinical trials In December 2014, GVK was alleged for falsification in...

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1

Dec 15

New online clinical trial application submission system by TGA (The Therapeutic Goods Administration)

New online clinical trial application submission system by TGA (The Therapeutic Goods Administration) TGA is the regulatory authority of Australia....

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1

Dec 15

Inconsistency in disclosure of information on clinical trials by Big Pharma giants

Inconsistency in  disclosure of information on clinical trials by Big Pharma giants As per the new study at NYU Langone...

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1

Dec 15

Steps taken by the Government to promote clinical research in India

Steps taken by the Government to promote clinical research in India Series of steps has been introduced by the government...

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28

Jul 15

FDA to ease down ways to gather and store clinical information surrounding data

FDA to ease down ways to gather and store clinical information surrounding data The Food and Drug Administration's “Center for...

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28

Jul 15

Provision of Jail term for violation of clinical trials having adverse impact on the patient

Provision of Jail term for violation of clinical trials having adverse impact on the patient The government of India is...

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28

Jul 15

Quest Life Sciences of Chennai, in trouble over defective clinical trial work under WHO

Quest Life Sciences of Chennai, in trouble over defective clinical trial work under WHO A warning have been issued by...

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28

Jul 15

Strict investigations into India’s clinical research firms by the regulators like FDA and WHO

Strict investigations into India’s clinical research firms by the regulators like FDA and WHO Recent violations in clinical research by...

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28

Jul 15

AB Science banned to perform drug studies by French Regulations due to side effects

AB Science banned to perform drug studies by French Regulations due to side effects AB is a biotechnology firm which...

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27

Jul 15

Health Tracking Wristband developed by Google for clinical research

Health Tracking Wristband developed by Google for clinical research A health-tracking wristband that can be used for clinical trial research and...

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27

Jul 15

Underlying barrier to conduct clinical trials on Parkinson’s disease determined by researchers

Underlying barrier to conduct clinical trials on Parkinson’s disease determined by researchers Although there is an urgent need for new...

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27

Jul 15

First Clinical Trial on Synthetic Human Blood by the U.K.s National Health Service

First Clinical Trial on Synthetic Human Blood by the U.K.s National Health Service Researchers were trying to develop fake blood...

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27

Jul 15

Data Sharing policy of BMJ now applicable on all clinical trials

Data Sharing policy of BMJ now applicable on all clinical trials The BMJ is the first general medical journal which...

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27

Jul 15

Successful completion of Pre-clinical trial for Hib (Haemophilus influenzae type b vaccine)

Successful completion of Pre-clinical trial for Hib (Haemophilus influenzae type b vaccine) Hib is a bacterium that can cause a...

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26

Jun 15

New technology by Quintiles and PRA for improvement in clinical trials

New technology by Quintiles and PRA for improvement in clinical trials Quintiles and PRA Health Sciences are leading contract research...

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26

Jun 15

No higher risk to extremely premature infants if included in clinical trials

No higher risk to extremely premature infants if included in clinical trials According to a study, extremely premature infants who...

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26

Jun 15

New Recommendations issued by the Clinical Trials Transformation Initiative (CTTI) for implementation of Quality By Design

New Recommendations issued by the Clinical Trials Transformation Initiative (CTTI) for implementation of Quality By Design The Clinical Trials Transformation...

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26

Jun 15

Clinical trial on promising Ebola Drug stopped

Clinical trial on promising Ebola Drug stopped An experimental drug to treat Ebola did not prove to be effective in...

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26

Jun 15

Easier procedures to be in place to get permission for clinical trials on human beings

Easier procedures to be in place to get permission for clinical trials on human beings The Pharmaceuticals Department under the...

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26

Jun 15

Statutory body for the conduct of clinical trials by Homeopathic Industry

Statutory body for the conduct of clinical trials by Homeopathic Industry According to The Homeopathy India Foundation (HIF), an independent...

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16

Jun 15

New tool to aid in designing more useful clinical trials

New tool to aid in designing more useful clinical trials Researchers at the University of Aberdeen through collaboration with over...

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16

Jun 15

Drug trials firm to challenge Health Research Authority plans to publish all results, even when a drug is shown not to be beneficial

Drug trials firm to challenge Health Research Authority plans to publish all results, even when a drug is shown not...

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16

Jun 15

New draft guidance from the US Food and Drug Administration (FDA) for Adaptive Design in Device Clinical Trials

New draft guidance from the US Food and Drug Administration (FDA) for Adaptive Design in Device Clinical Trials New draft...

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16

Jun 15

Call for reforms on clinical trials on Children by Bioethics Council

Call for reforms on clinical trials on Children by Bioethics Council Companies often are not comfortable to conduct clinical studies...

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16

Jun 15

Guidelines Released for GCP monitoring of clinical trials in Nordic Countries

Guidelines Released for GCP monitoring of clinical trials in Nordic Countries In the Nordic countries GCP Units linked to hospitals...

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16

Jun 15

Promotion of Columbia as a destination for clinical research

Promotion of Columbia as a destination for clinical research Columbia is located close to US and is the third most...

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16

Jun 15

Launch of Canadian Clinical Trials Asset Map to show Canadian Clinical Research Capabilities

Launch of Canadian Clinical Trials Asset Map to show Canadian Clinical Research Capabilities The Canadian Clinical Trials Coordinating Centre (CCTCC)...

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21

May 15

New guidance released by FDA for clinical trial Sponsor-Investigator

  New guidance released by FDA for clinical trial Sponsor-Investigator New guidance issued by the US Food and Drug Administration...

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21

May 15

Ethical Violations in Zimbabwe’s Clinical Trial

Ethical Violations in Zimbabwe's Clinical Trial The monitoring and supervision of clinical trials in Zimbabwe have showed ethical violations related...

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21

May 15

Bioethics Panel Created by Johnson and Johnson on trial drugs

Bioethics Panel Created by Johnson and Johnson on trial drugs A nationally known bioethicist had been appointed by Johnson and...

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21

May 15

New manufacturing clinical trial models by India to sell generics to Japan

New manufacturing clinical trial models by India to sell generics to Japan For several years, Japan's policy has been to...

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21

May 15

Two biosimilar drugs from BIOCON enter global phase 3 clinical trials

Two biosimilar drugs from BIOCON enter global phase 3 clinical trials Biocon is an Asia's premier biotechnology company and has...

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11

May 15

Guidelines established for Clinical Trial Group By NAFDAC(The National Agency for Food and Drug Administration and Control)

Guidelines established for Clinical Trial Group By NAFDAC (The National Agency for Food and Drug Administration and Control) The first...

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11

May 15

New Clinical Trial Provisions by draft US House Bill

New Clinical Trial Provisions by draft US House Bill A new draft US house bill from the House Energy and...

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11

May 15

Guidance Issued by Chinese pharmaceutical authorities on international multi-center clinical trials of drugs in China

Guidance Issued by Chinese pharmaceutical authorities on international multi-center clinical trials of drugs in China Chinese pharmaceutical authorities have officially...

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11

May 15

Selection of Critical Path Institute for New Tuberculosis (TB) clinical trial data sharing platform

Selection of Critical Path Institute for New Tuberculosis (TB) clinical trial data sharing platform For the first time trial sponsors...

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11

May 15

Clinical Trial on malarial vaccine show that it is less effective

Clinical Trial on malarial vaccine show that it is less effective The first candidate malarial vaccine RTS,S/AS01which was first to...

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30

Apr 15

Establishment of Site Advocacy Group by INC Research for Improvement of Key Aspect of Clinical Trial Management

Establishment of Site Advocacy Group by INC Research for Improvement of  Key Aspect of Clinical Trial Management  INC Research is...

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30

Apr 15

Attempt to simplify the process for medical device manufacturers in order to use foreign clinical trial data

Attempt to simplify the process for medical device manufacturers in order to use foreign clinical trial data A new document...

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30

Apr 15

Hope on TrialReach to enrol patients in clinical trials faster

Hope on TrialReach to enrol patients in clinical trials faster TrialReach is a platform to facilitate patients' access to trial...

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30

Apr 15

Final trial results published on world’s most advanced malarial vaccine

Final trial results published on world's most advanced malarial vaccine Malaria is caused by a parasite and is transmitted through...

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30

Apr 15

New Tools released by Clinical Trials Transformation Initiative (CTTI) to Help Organizations Implement Single IRBs in Multi-Center Clinical Trials

New Tools released by Clinical Trials Transformation Initiative (CTTI) to Help Organizations Implement Single IRBs in Multi-Center Clinical Trials New...

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21

Apr 15

Clearance of proposal on regulation of clinical trials by Health Ministry Of India

Clearance of proposal on regulation of clinical trials by Health Ministry Of India A proposal to regulate clinical trials and...

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21

Apr 15

Disclosure of all clinical trial results demanded by WHO (World Health Organization)

Disclosure of all clinical trial results demanded by WHO (World Health Organization) The World Health Organization has demanded for the...

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21

Apr 15

Clinical trial to test the effectiveness of PTSD app for treating Post Traumatic Stress Disorder

Clinical trial to test the effectiveness of PTSD app for treating Post Traumatic Stress Disorder A clinical trial to test...

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21

Apr 15

Promising Results on personalized skin care vaccine in clinical trial

Promising Results on personalized skin care vaccine in clinical trial Early data from a "first-in-people" clinical trial at Washington University...

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21

Apr 15

New clinical trial study on smaller version of temporary total artificial heart

New clinical trial study on smaller version of temporary total artificial heart FDA has approved a clinical trial to investigate...

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21

Apr 15

Thoratec Corporation received FDA approval to expand HeartMate III US trial

Thoratec Corporation received FDA approval to expand HeartMate III US trial Thoratec's HeartMate III is a next-generation continuous-flow left ventricular...

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21

Apr 15

UNT Health Science Center is recruiting participants For Alzheimer’s Clinical Trials

UNT Health Science Center is recruiting participants For Alzheimer's Clinical Trials Researchers at UNT Health Science Center at Fort Worth...

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21

Apr 15

New Phase II oncolytic viral therapy clinical trial is being offered by St. Luke’s Cancer Center for advanced melanoma

New Phase II oncolytic viral therapy clinical trial is being offered by St. Luke's Cancer Center for advanced melanoma  St....

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21

Apr 15

Increased Death Risk by AstraZeneca’s Diabetes drug according to FDA

Increased Death Risk by AstraZeneca's Diabetes drug according to FDA An increased risk of death was found from AstraZeneca Plc's...

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21

Apr 15

There may be new drugs for treatment of diseases Like Malaria and Diabetes

There may be new drugs for treatment of diseases Like Malaria and Diabetes According to Dr Harsh Vardhan, the Union...

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8

Apr 15

Clinical Trial on Cryoablation Treatment for Primary Breast Cancer

Clinical Trial on Cryoablation Treatment for Primary Breast Cancer Cryoablation is a technique which uses extreme cold to kill (ablate)...

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8

Apr 15

Australian DFAT grant given to TB alliance to support late stage clinical trials of new Tuberculosis Drugs

Australian DFAT grant given to TB alliance to support late stage clinical trials of new Tuberculosis Drugs TB alliance is...

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8

Apr 15

Effectifveness of combination strategies is being explored in Castration-Resistant Prostate Cancer (CRPC)

Effectifveness of combination strategies is being explored in Castration-Resistant Prostate Cancer (CRPC) Clinical trials allow patients access medications before they...

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8

Apr 15

PREVAIL clinical trial in Liberia appears to demonstrate safety of two experimental Ebola Vaccines

PREVAIL clinical trial in Liberia appears to demonstrate safety of two experimental Ebola Vaccines PREVAIL clinical trial began on 2nd...

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8

Apr 15

DX-2930 received Fast Track designation from the FDA for the treatment of hereditary angioedema attack

DX-2930 received Fast Track designation from the FDA for the treatment of hereditary angioedema attack DX-2930 is an investigational product...

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26

Mar 15

Phase 1b trial with Aducanumab for treatment of Alzheimer’s disease shows statistically significant results

Phase 1b trial with Aducanumab for treatment of Alzheimer’s disease shows statistically significant results 166 patients over a period of...

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26

Mar 15

Serious Challenge to Clinical Studies due to decline in Ebola Cases

Serious Challenge to Clinical Studies due to decline in Ebola Cases According to an analyst with research and consulting firm...

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26

Mar 15

Selten Pharma’s drug for the treatment of Pulmonary Arterial Hypertension granted Orphan Drug Status by USFDA

Selten Pharma’s drug for the treatment of Pulmonary Arterial Hypertension granted Orphan Drug Status by USFDA Selten Pharma is a...

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26

Mar 15

Increase by 33 % in backlog of China’s New Drug Approvals

Increase by 33 % in backlog of China’s New Drug Approvals According to the China FDA's Center for Drug Evaluation,...

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26

Mar 15

Scientific Review Board established by AstraZeneca to support clinical trial data transparency

Scientific Review Board established by AstraZeneca to support clinical trial data transparency A  Scientific Review Board that will act independently...

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16

Mar 15

Psoriasis Symptoms dramatically improved by New Antibody Therapy in Clinical Trial

Psoriasis Symptoms dramatically improved by New Antibody Therapy in Clinical Trial Psoriasis is a disease in which the body’s immune...

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16

Mar 15

A study led by NIH to assess community-based hepatitis C treatment in Washington, D.C.

A study led by NIH to assess community-based hepatitis C treatment in Washington, D.C. National Institute Of Health and the...

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16

Mar 15

Epstein Barr Virus (EBV) targeted T cells received breakthrough therapy designation by FDA

Epstein Barr Virus (EBV) targeted T cells received breakthrough therapy designation by FDA Memorial Sloan Kettering Cancer Center (MSK) has...

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16

Mar 15

Many Clinical Trials results are not being reported to public

Many Clinical Trials results are not being reported to public According to 2007 law, results of clinical trials are to...

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16

Mar 15

Positive Results From Phase III Clinical Trial In Hemophilia reported by Baxter

Positive Results From Phase III Clinical Trial In Hemophilia reported by Baxter Trial design was “The prospective, open-label, randomized, multicenter...

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15

Jan 15

Promising Results Shown by the Phase 1 Clinical Trials of Ebola Vaccines

Promising Results Shown by the Phase 1 Clinical Trials of Ebola Vaccines Two Ebola vaccines, namely, ChAd3-ZEBOV by GlaxoSmithKline and...

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15

Jan 15

Antria Phase 2 Stem Cell Clinical Trials Approved by FDA

Antria Phase 2 Stem Cell Clinical Trials Approved by FDA         For making people utilize their own stem cells and look...

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15

Jan 15

Apex Court Strikes on Centre Regarding Issue of Clinical Trials

Apex Court Strikes on Centre Regarding Issue of Clinical Trials Stating that the government should be concerned about the health...

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15

Jan 15

Trials for Flu Vaccine to be held later this Year

Trials for Flu Vaccine to be held later this Year Influenza symptoms appear in millions of Americans every year. These...

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15

Jan 15

Integrated Software and Ingestible Sensors Launched by Proteus and Oracle for Clinical Trials

Integrated Software and Ingestible Sensors Launched by Proteus and Oracle for Clinical Trials Proteus’s digital health feedback system has been integrated...

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8

Jan 15

Compensation of Clinical Trial Deaths Meets New Values

Compensation of Clinical Trial Deaths Meets New Values Compensation is paid in case of death resulting from clinical trials and...

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8

Jan 15

Amendment made to 122 DAB – recently notified by CDSCO

Amendment made to 122 DAB – recently notified by CDSCO Rule 122 DAB of the Drugs and Cosmetics Act, 1945...

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7

Jan 15

United States (US) criticizes the rules and regulations of the Indian Clinical trials

United States (US) criticizes the rules and regulations of the Indian Clinical trials Owing to its large English-speaking population and...

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7

Jan 15

Clinical Trials Begin for Ebola drugs by Johnson and Johnson

Clinical Trials Begin for Ebola drugs by Johnson and Johnson Ebola is a disease which has killed around 8,000 people...

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27

Dec 14

Only 21 cases get compensation out of 370 Deaths during Trials in 2 Years

Only 21 cases get compensation out of 370 Deaths during Trials in 2 Years Although clinical trials are under scrutiny...

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27

Dec 14

Approval Given to 28 Proposals on Clinical Trials by Apex Committee

Approval Given to 28 Proposals on Clinical Trials by Apex Committee After approval by the Subject Expert Committees (SECs) and...

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27

Dec 14

Decline in the number of clinical trials in India“ A loss to Patients”

Decline in the number of clinical trials in India“ A loss to Patients” Only 25 Global Clinical Trials (GCTs) had...

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27

Dec 14

New South Wales (NSW) starts medical cannabis trials

New South Wales (NSW) starts medical cannabis trials Trials on medical cannabis will start in NSW (New South Wales) but...

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27

Dec 14

German ban doesn’t stand to 18 generic drugs

German ban doesn’t stand to 18 generic drugs On account of being legally challenged by the manufacturers of generic drugs...

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9

Dec 14

Ban on Flexion’s lead drug by FDA released

Ban on Flexion’s lead drug by FDA released Osteoarthritis is the commonest type of arthritis in the United States affecting...

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9

Dec 14

Approval can be sought by Bayer against its drug for hemophilia

 Approval can be sought by Bayer against its drug for hemophilia  Hemophilia occurs due to mutation in a gene which...

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9

Dec 14

Late stage Alzheimer’s trial leads to rise in shares of Biogen

Late stage Alzheimer’s trial leads to rise in shares of Biogen Alzheimer’s disease (dementia) has sufferers of around 36 million...

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9

Dec 14

Drug approved by U.S. FDA ahead of schedule

Drug approved by U.S. FDA ahead of schedule National Cancer Institute reported that in the year 2014, 6,020 Americans will...

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9

Dec 14

Testing of Ebola vaccines by Merck/New Link shows no serious adverse effects

Testing of Ebola vaccines by Merck/New Link shows no serious adverse effects WHO figures reported that the outbreak of Ebola...

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9

Dec 14

Disapproval of GVK Bio’™s clinical trials was given by European Union (EU) health regulators

Disapproval of GVK Bio’s clinical trials was given by European Union (EU) health regulators The approval of 25 generic drugs...

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9

Dec 14

For new clinical trials, quality accreditation is to be made mandatory

 For new clinical trials, quality accreditation is to be made mandatory The Government of India plans to make quality accreditation...

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5

Dec 14

Draft guidance document on Research for biological (biomedical) prevention of HIV infection released by ICMR

Draft guidance document on Research for biological (biomedical) prevention of HIV infection released by ICMR For promoting research on biological/biomedical...

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5

Dec 14

Social media networks playing vital role in type 1 diabetes research

Social media networks playing vital role in type 1 diabetes research Type 1 diabetes develops when the immune system in...

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5

Dec 14

Supreme Court stunned by the number of clinical trial deaths demands details from Centre

Supreme Court stunned by the number of clinical trial deaths demands details from Centre The Supreme Court of India has...

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27

Nov 14

welcome to clinical research

Clinical Research covers all steps and processes which are a part of a drug’s lifecycle i.e. from researching the molecule,...

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