Clinical trials require controls and robust informed consent. However, ethicists argue if the one-size-fits-all approach should be customized to the perceived risk of a given trial. Should the trail risk be determined by the regulators and the information shared with the participants via the informed consent be reduced for lower-risk trials to encourage more investigator … Read more
Twenty years ago, the FDA halted all gene therapy clinical trials based on reports from France of cancers in children who received gene therapy. When last week, it was reported that deadly cancers emerged within 2 years in seven out of 67 children who received an FDA-approved gene therapy, the Agency took a wait and … Read more
Most discussions about the lack of diversity in clinical trials are focused on studies for drugs and biologics, not much is discussed publicly about the diversity of trial participants in medical device clinical trials. This week the FDA started publishing the “Device Trial Participation Snapshots” which shows important demographic trends for medical device clinical trials. … Read more
Institutional Review Boards (IRBs) are the surrogates of the FDA for regulating clinical trials by ensuring compliance by the investigators under their purview. But occasionally IRBs may falter in their responsibilities leading to negative audit findings. This is what happened with the IRB at Lousiana State University Health Science Center (LSUHSC) which was found to … Read more
The FDA has been rolling forward with the implementation of the new medical device rules whereby the Lab Developed diagnostic Tests (LDTs) will be converted to conventional In Vitro Diagnostic (IVD) devices or removed from the market. It is the responsibility of the manufacturers of LDTs to navigate the new regulatory environment. A new page … Read more
Electronic medical records and other electronic systems are ubiquitous sources of the source data for clinical trials. There is confusion and misinformation about the FDA requirements from such data particularly in pragmatic trials where the clinics participating in the clinical trial also provide health care services. FDA’s new guidance on the topics answers many common … Read more
The submission and tracking portal maintained by the Center for Devices (CDRH) at the FDA is an enhanced tool for not only the electronic submission of almost all device applications but also for tracking the progress of the review and interacting with the FDA reviewers. This week, the FDA added more functions to it. The … Read more
Peer-reviewed publications are the currency of scientific research, the number of publications being directly correlated to the credibility of the research being discussed. But there also have been reports of rampant manipulation and misrepresentation of data in scientific publications. So, how much can one rely on published literature in support of the clinical potential of … Read more
Clinical trials are run at clinics with patients, that’s how it has been for the last. So, the new FDA guidance on how to run trials at clinics may come as a surprise to many doing such trials for the last few decades. Doctors act as investigators and patients become subjects at the same location. … Read more
Clinical trials have become increasingly globalized over the last three decades with sponsors routinely conducting multinational clinical trials to evaluate new drugs. A new guidance document from the FDA seems to indicate that the FDA would like to buck that trend. The guidance document lists several previous requirements with a new tone that seems to … Read more
