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 AI and machine learning in clinical trials, and updates for legislation/guidance from each of the three regulatory bodies.
Day 3 was dedicated to BE/BA studies including the issues and challenges experienced both within the clinic 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 encouraged sponsors of clinical trials to have communication with them up front for novel trial designs or anticipated challenges to conduct 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 and 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 any further information, please contact David O’Connor at D.OConnor@LachmanConsultants.com