Biotrial

Disclosures bring continued focus to Bial trial

Thursday, June 1, 2017

Last year, two issues of Research Practitioner included a discussion about a French trial in which one healthy volunteer died and five others were hospitalized. Researchers and pharmacologists are becoming more critical of the trial as new information become available. Were the researchers negligent? Why was this compound chosen over other similar ones for the study?

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VP Biden Comments on Trial Reporting Deficiencies

Monday, August 1, 2016

Two stories in the March/April 2016 issue of Research Practitioner recently have been updated. The first, “Bial Trial Highlights Reporting Deficiencies,” highlighted a study by the publication STAT that looked at the mandatory reporting of results of human studies of new treatments to the federal government’s ClinicalTrials.gov database.1

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EMA proposes changes to first-in-human trials spurred by January’s Bial trial deaths

Monday, August 1, 2016

Are the risks faced by phase I clinical trial participants too great? The European Medicines Agency (EMA), the European Commission and the Member States of the European Union (EU) believe so. Together, they’re proposing changes to current guidance on first-in-human clinical trials that would, if successful, improve strategies for identifying and mitigating risks to study subjects.

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Trial volunteer death throws spotlight on disclosure

Friday, April 1, 2016

On Jan. 1, 2016, clinical researchers heard news that they dread: Healthy volunteers in a drug trial experienced serious side effects. One volunteer in the French trial died and five others were hospitalized with neurological symptoms. Questions now remain as to how this happened and how the tragedy will affect clinical trials in Europe and in the United States.

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