Sponsors looking to increase diversity in clinical trials should, among other things, “meet patients where they are,” hire a more diverse pool of trial investigators, train nonminority investigators and deploy a patient-centric model for trials that includes input from Community Advisory Boards (CABs). Read More
This monthly feature presents questions from clinical trial professionals answered by a variety of experts in the field. This month’s questions and answers come from the WCG Institute’s Ask the IRB Experts column and from the Secretary’s Advisory Committee on Human Research Protections (SACHRP) document, New Information Provided to Previously Enrolled Research Subjects. Read More
In an update to the FDA’s guidance on conducting trials during the pandemic, the agency has reminded investigators of their responsibility to review all adverse events (AE) and report to their IRBs any potential risk to trial participants. Read More
In a stunning departure from how FDA guidances are issued by the agency, President Donald Trump said Wednesday evening that he might move to reject a guidance that is expected to impose stricter thresholds for any COVID-19 vaccine Emergency Use Authorizations (EUAs). Read More
AstraZeneca (AZ) has released the trial protocol for the late-stage study of its coronavirus vaccine candidate AZD1222 as its investigation into an adverse event continues. Read More
The European Medicines Agency (EMA) has released a draft guidance document on how best to use registries as a source of real-world evidence to support clinical trials. Detailed advice is provided on the use of disease registries or condition registries to evaluate the safety and efficacy of therapeutic agents during pre- and post-authorization phases. Read More
