FDA Commissioner Warns of Shutdown’s Impact on Clinical Trials

January 14, 2019

As the partial government shutdown entered a record-setting fourth week, FDA Commissioner Scott Gottlieb said it was no longer “business as usual” at the agency — calling the shutdown “one of the most significant operational challenges in FDA’s recent history.”

Establishing Indemnification in a Clinical Trial Agreement Requires Precise Language

January 14, 2019

Negotiating a clinical trial agreement (CTA) can be a maze of confusion, filled with difficult-to-understand legalese and contractual traps seemingly around every corner. An accidental omission, an unintended commitment, or even just the wrong choice of words can lead to misunderstandings and an agreement that fails to do what you want it to.

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.