Dr. Ignazio di Giovanna, ARG Vice-President of European Operations, appears here in the blog to weigh in on two issues: Brexit implications for clinical trials in the UK, and a recent article in Outsourcing-Pharma entitled “England sees highest ever clinical trial participation rates: NIHR.”
The UK’s clinical trials submission and approval system, regulated by the UK’s Health Regulatory Authority (HRA), which now incorporates both Competent Authority and Central Ethics approvals in one combined step, is one of Europe’s fastest and most predictable regulatory pathways.
Much furore is currently being made of the potential threat of Brexit to the UK’s ability to continue to provide its strong offering in performing clinical trials and clinical research in general. The reality is that the perceived risks are likely unfounded and overblown.
Implementation of the EU’s Clinical Trials Regulation is now anticipated in December 2020, in all likelihood after the UK’s withdrawal from the EU; therefore, the timeline of instituting the standards will have no bearing on the UK’s activities, and current procedures will continue.
The HRA and MHRA process is now in an advanced state of implementation and has been designed to be fully aligned with the new EU process. At the same time, the combined ways of the working pilot (which is the precedent of the proposed procedure) is also in compliance with EU’s CT-1 and CT-2 (please see notes below). The end result will be that the current modus operandi will be maintained in the UK – and can only improve if the UK is granted access to the EU electronic portal following full implementation of the EU Regulation. (The original implementation date in 2014 has been delayed due to issues with this electronic portal.)
A recent article in Outsourcing-Pharma by Melissa Fassbender demonstrates the strength of clinical trial participation as well as upcoming clinical project investment in England. Clinical research in England is growing at a record-setting pace with support from a recent £20.5bn investment to transform service delivery – as the NHS looks to conduct more studies in primary care settings. The last 12 months has shown a record increase of over 2000 new studies, bringing the total to over 6000 ongoing studies. With every NHS trust now recruiting patients into clinical trials, UK trial participation is set to rise even further.
Navigating clinical trial uncertainty in the UK, US, and around the world can be challenging. ARG is here to help. Please contact firstname.lastname@example.org to learn more.
- CT-1: Detailed guidance on the request to the competent authorities for authorisation of a clinical trial of a medicinal product for human use, the notification of substantial amendments and the declaration of the end of trial.
- CT-2: Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use.
(Photo by David Dibert)