In the past, drug trials have taken months or years to conduct with reams of data to analyze before a sponsor could go to a regulator for product approval. But under the emergency conditions caused by the pandemic, vaccine approvals will be based on early data analysis and much smaller data sets. Read More
Attendees at last week’s WCG FDAnews 15th Annual FDA Inspections Summit peppered compliance experts with a variety of questions related to handling remote operations during the pandemic. Craig Lipset, adviser and founder of Clinical Innovation Partners; Jen Keun, compliance lead at LMC Manna Research; and David Borasky, WCG Clinical’s vice president of IRB compliance, discussed some of the thorniest aspects of operating trials remotely. The following is a summary of the question-and-answer session. Read More
Sponsors of nonfederally funded clinical trials can request a certificate of confidentiality (CoC) that protects them from being compelled to disclose participants’ private information, according to a final FDA guidance released last week. Read More
Four new tools from the Clinical Trials Transformation Initiative (CTTI) help sponsors and sites incorporate quality-by-design (QbD) principles in their trials. Read More
The Bristol Myers Squibb (BMS) Foundation has launched a $100 million diversity program with National Medical Fellowships to reduce racial and ethnic disparities in trials. Read More
