India’s Ministry of Health and Family Welfare on Friday began releasing data about drugmakers’ payouts in cases where clinical trial subjects died during a trial, with the first wave of published data focusing on payouts for trial-related deaths between 2010 and 2013. Read More

Videotapes of patients giving informed consent to participate in clinical trials must show the investigator explaining the study protocol in language the subject can understand, according to a draft guideline by India’s Central Drugs Standard Control Organization. Read More

Vaccine trial sponsors should report study-related fatalities within seven days of an event and submit follow-up reports by eight days later, a recent China Food and Drug Administration guideline says. Read More

The IRB at a major Chicago hospital has been handed an FDA warning letter for a slew of violations in a device clinical trial, many of which were first observed at the site over a decade ago. Read More

Johnson & Johnson unveiled a first-of-kind clinical trial data-sharing plan that it hopes will become a model for industry transparency initiatives: rather than provide direct access to trial data, sponsors could contract with third parties to serve as gatekeeper and approve data access requests. Read More

While EU regulators push ahead with a trial transparency initiative, the Institute of Medicine has stepped into the debate, seeking feedback on a wide range of proposals to encourage clinical data sharing in the U.S. Read More

Sponsors conducting clinical trials in India must fully inform study patients about potential payments resulting from adverse events during videotaped informed consent sessions, a draft guideline says. Read More

Sponsors of clinical trials in India must inform enrollees during videotaped informed consent sessions about potential payments resulting from adverse events, a draft guideline says. Read More

The Institute of Medicine is seeking comment on a wide range of proposals that would encourage data sharing in device clinical trials in an effort to foster discussion about what level of transparency is appropriate. Read More

Johnson & Johnson Thursday unveiled a clinical trial data-sharing plan that it hopes will become a model for all industry transparency initiatives: instead of providing direct access to trial data, a third party will serve as gatekeeper and approve access requests for data. Read More

To foster discussion on what level of transparency on clinical trials is appropriate, the Institute of Medicine (IOM) is seeking comment on a wide range of proposals that would encourage clinical data sharing. Read More

A key panel of the European Parliament on Wednesday advanced draft legislation revising EU clinical trial regulations, setting up a final vote for replacing the current trial directive in April. Read More