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The FDA is advising devicemakers that plan to support a premarket submission with data from clinical studies conducted outside the U.S. to meet with the agency before finalizing their trial designs. Read More
A new interactive clinical data platform for Apple devices is capable of not only boosting participation in data-driven disease studies, but also collecting clinical data more easily, the tech giant says. Read More
The FDA saw an 11 percent increase in inspections carried out as part of a sweeping program to improve inspectors’ understanding of clinical practices during fiscal year 2014. Read More
The FDA and Department of Justice are pursuing prosecutions of several international drugmakers, investigators and clinical trials coordinators for conduct and data integrity violations, underscoring the agency’s increasing tendency to treat quality violations as fraud. Read More
AstraZeneca is catching the clinical trial transparency wave, creating a new scientific review board to evaluate requests for the company’s data. Read More
Future models for obtaining informed consent from a patient in secondary data-based studies need to consider what patients really care about, a recent study in PLOS One concludes. Read More
Possible conflicts of interest, such as industry payments to a clinical investigator for running trials, should be disclosed to trial participants during the informed consent process, a group of trial experts says. Read More
Consumer advocacy watchdog Public Citizen is calling for an in-depth investigation of alleged human subject protection violations at the University of Minnesota between 2011 and 2014 and revocation of the university’s human subjects research credentials. Read More
The UK’s Medicines and Healthcare products Regulatory Authority approved approximately one-quarter of Phase I and one-third of Phase II-IV clinical trials on first review between April 2014 and March of 2015. Read More
The European Medicines Agency is revising the way drugmakers conduct studies for drugs to treat blood clots, for the first time separating out the clinical requirements for different types of clots. Read More