The MHRA Good Clinical Practice Symposium was a virtual event this year due to COVID 19. More than 800 individuals from over forty countries across the globe attended. Throughout the three-day event, speakers provided their perspectives on clinical trials from their roles as inspectors, assessors and reviewers representing the MHRA, FDA and Health Canada. The agenda provided an opportunity for the audience to understand the challenges faced by these regulatory bodies during the pandemic, how they had to quickly pivot to alternative means to continue to carry out their responsibilities, what the agencies learned, how they may consider adapting their inspections post-pandemic and potential efficiencies gleaned from these last two years. Attendees took advantage of the opportunities to ask questions of the speakers and the Q&A sessions were quite informative.

The first two days of this remote symposium covered various clinical trial topics such as clinical trial design, sponsor oversight, real-world data and real-world evidence, decentralized trials, use of artificial intelligence (AI) and machine learning (ML) in clinical trials, and updates for legislation/guidance from each of the three regulatory bodies.

Day 3 was dedicated to BE/BA studies and the issues and challenges experienced both within the clinics and bioanalytical laboratories. Regulatory updates were also provided, along with a presentation for the draft of ICH M10 “Bioanalytical Method Validation Guideline.” As expected (and eagerly anticipated by the attendees, I’m sure) the regulators shared recent case studies including intentionally compromising data integrity from the clinical and bioanalytical aspects of BE/BA studies.

The main takeaways from my perspective were:

1. Do not be surprised if future inspections from MHRA and Health Canada utilize a hybrid approach (an inspection having both remote and on-site elements).

2. Regulators were encouraging sponsors of clinical trials to have communication with them up front for novel trial designs or anticipated challenges to conducting a clinical trial.

3. Sponsors and other stakeholders should constantly evaluate the risks associated with trials and mitigate these risks as much as possible.

4. All stakeholders need to be involved in a study’s design.

5. Sponsors, although you may delegate trial-related duties to CROs, you are ultimately responsible for your clinical trials—you have everything to gain in their success, or everything to lose if there is a critical failure.

6. Despite the pandemic, the fundamentals of running clinical trials have not changed as you must: continue to follow the regulations and your protocols; ensure adequate documentation with justification and impact when you do not; ensure that the rights, health and safety of the trial participants are front and foremost; and ensure that the data generated is accurate, complete, and consistent and meets the requirements of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate); however, the precise ways that clinical trials are conducted are always evolving, as this pandemic demonstrated.

If you have a need for assistance in supporting your clinical trials, whether it is initial discussions with the Agency through to submission of the application (or any point in between), our team at Lachman Consultants are here to work with you.

For more information email D.OConnor@LachmanConsultants.com

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David S. O’Connor is a Senior Director at Lachman Consultants and an accomplished quality assurance professional with over thirty years of experience in pharmaceutical research from a sponsor, contract research organization (CRO) and consulting perspectives. He has extensive QA experience in all aspects of clinical (GCP) and preclinical (GLP) studies and experience with manufacturing (GMP) quality assurance responsibilities in R&D solid-dose formulations. He delivers leadership in the preparation, coordination, and follow-up of regulatory inspections by U.S. FDA, Health Canada, EMEA and ANVISA along with sponsor study and site qualification audits.