Features

Interview: Challenges and Opportunities in Psychiatric Trials

December 31, 2018

In a recent conversation on the current psychiatric clinical trials environment, Mark Opler, MD, chief research officer at WCG-MedAvante-ProPhase, had the opportunity to gather insights from noted clinical psychiatrist and researcher Christoph Correll, MD. Dr. Correll’s work focuses on the identification, characterization and treatment of adults and youths with severe psychiatric disorders. His particular area of expertise is psychopharmacology.

Dr. Opler: Could you tell us what you see as the top three challenges in our current clinical trials environment?

Dr. Correll: Unfortunately, we’ve seen many programs look promising but ultimately fail. The transition from Phase II to Phase III has been particularly difficult, and we need to understand that better. We get signals in smaller trials that are suggestive, but once they go into large explanatory Phase III trials, the results are disappointing.

Debarment Certification: A Must-Have in Any Clinical Trial Agreement

December 17, 2018

The debarment certification is one of the sections of central importance in a clinical trial agreement (CTA). This certification is a representation or warranty made by the institution, principal investigator, and, if applicable, affiliated hospitals or third-party facilities, that it is not debarred, disqualified or banned by the FDA from conducting clinical trials.

FDA: New Approaches for Fatty Liver Clinical Trials

December 10, 2018

The FDA is encouraging fatty liver disease researchers to come up with new biomarkers for clinical trials to avoid invasive — and potentially dangerous — biopsies that drive away many would-be participants.

New Training Standards Sought for PIs

December 3, 2018

Two influential clinical industry groups are focusing on new training efforts to prevent principal investigators from burning out and it appears that the FDA is willing to work with them on the effort.

FDA Wants to Modernize 510(k) Trials

December 3, 2018

The FDA says it wants to modernize device clinical trials by using more up-to-date technologies as comparators to make sure only the safest, most effective devices get to market.