Potential Updates to FDA’s Protocol Deviations Guidance

In a recent video interview with Applied Clinical Trials, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, discussed FDA's recent guidance on protocol deviations and its impact on clinical trial management. She highlighted the importance of quality by design (QbD) and critical to quality (CTQ) factors in reducing protocol deviations. Pomerantseva views this guidance as an official acknowledgment of existing practices and an opportunity for improvement.

ACT: How do you think FDA’s protocol deviations (PDs) guidance will affect the industry moving forward into the future?

Pomerantseva: I see it as a great first step in acknowledging the complexity of this process and providing more clarity to the industry, and therefore, I hope that all the industry professionals will take advantage of the opportunity to provide comments. I actually reviewed some comments a couple of days ago. There is not too many, so I would envision that we could collaborate much better on helping ourselves to have a more consistent and more concise document.

I would definitely expect more details in the guidance, and then it's going to evolve over time, but again, I'm a now person, let's see what we can do now, not waiting for another revision since we have the chance. For example, I would expect more guidance on a couple things, and I'm going to be very specific or what I haven't seen there, but I would want to. Serious breaches: at what point should important PDs be assessed for being serious breaches, if it should be assessed, and what role should be involved? Maybe it should reference a dedicated serious breaches guidance, but I haven't seen anything in there. Governance, metrics, and escalation: it is a big topic in ICH E6(R3), but I have not seen anything on this topic in the protocol deviation guidance.