Vera Pomerantseva of eClinical Solutions Reacts to FDA’s Recent 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: What was your initial reaction to FDA issuing the recent protocol deviations (PDs) guidance?

Pomerantseva: I was really excited. I think this is a fabulous opportunity to achieve more clarity and consistency in the process. Honestly, previous multiple documents and guidance, such as ICH E6(R3) touched upon protocol deviations, but it's the first time a health authority has actually issued a guidance which is entirely dedicated to the management of protocol deviations. Obviously, the process is not new, and it always existed. As long as protocols are there, it will exist, and the deviations are going to be there, so we have to deal with them as part of the clinical trial management process. Over my, I would say, 24 years in the industry, and I was in the big pharma for quite a long time, and then in consulting for big pharma, there always was efforts, as long as I remember myself to streamline the process, to improve the process. Actually, in 2015 TransCelerate did a great job to collaborate with industry peers and pull together common industry practices, some recommendations, so it helped industry a lot to use more consistent terminology, have the process responsibility, but obviously it doesn't have the power of a health authority guidance. I was also happy to see a certain level of detail in this new guidance, like mentioning intentional PDs, talking about categories and types, touching on GCP issues versus protocol deviations. It's not always clear, what is what, I know there are lots of confusions there, clarifying roles, responsibilities. It talks about certain aspects of reporting, of important PDs and non-important PDs. I think it's a great first step, but still a lot of work to be done to reduce some PDs here.