Since April 2018, the NHS Health Research Association (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have been piloting a new process to offer a single clinical trial application route with a single UK decision, combining the Research Ethics Committee (REC) opinion as well as the MHRA Clinical Trial Authorisation (CTA).
The new combined process is part of the regulators' implementation of the EU Clinical Trials Regulation 536/2014 in the UK, due to come into full effect in 2020.
The new process involves a single Clinical Trials of Medicinal Products (CTIMP) application dossier being submitted for both CTA and REC opinion, and in England and Wales this also incorporates HRA and Health and Care Research Wales (HCRW) approval. The reviews are then undertaken independently, but the outcomes are coordinated to ensure that any requests for further information or changes to documentation are compatible. CTIMP applicants then receive a single communication confirming the final decision.
The HRA's review of the pilot one year on highlights that the applications dealt with through the new process have had a mean approval of 42 days from submission to authorisation, including HRA/HCRW approval where relevant.
The pilot has been open to applications by prior agreement only but will be opened up to all CTIMPs eventually. Parties interested in submitting a CTIMP in the pilot can enquire here. So far, only certain RECs are involved in the pilot, but the number is set to increase over the coming months, as can be seen in the REC meeting schedule.
The HRA has published a suite of documents on the pilot, including FAQs, guidance, instructions to sponsors for new applications and substantial amendments/end of trial notifications, informed consent procedure template, and a non NHS/HSC Site Assessment Form.
The MHRA's Dr. Martyn Ward, Senior Responsible Owner, Clinical Trials Programme, spoke at the BIA's Regulatory Innovation Conference on September 17, 2019, discussing the success of the pilot programme and its forthcoming expansion. Dr. Ward mentioned that the MHRA's target time for initial assessment is 30 days, with a target for final approvals within 60 days.