The Combined Ways of Working (CWoW) pilot has now been running for 12 months. We give an update on how the pilot has developed and set out our plans for the upcoming months.
The HRA and MHRA, in partnership with the Devolved Administrations, have been piloting a streamlined process for the submission and review of applications to run Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK. The process aligns with the requirements of the EU Clinical Trial Regulation 536/2014, and is helping to prepare the UK for a future regulatory landscape.
The Combined Ways of Working pilot requires a single CTIMP application to be submitted for both the Clinical Trial Authorisation (CTA) and the Research Ethics Committee (REC) opinion. The reviews are undertaken independently, but the outcome of the review is co-ordinated to ensure that any requests for further information or changes to documentation are compatible. Applicants receive a single co-ordinated communication to request further information or document changes, and a single communication to confirm the final decision
Some of the highlights of the first year of the pilot include:
- a mean approval of 42 days from submission to authorisation, including HRA/HCRW approval where relevant
- co-ordinated requests for further information between
the REC and MHRA achieved for all applications
- responses to requests for further information
from applicants received within the 14-day requirement
- applicant guidance documents developed and published to support organisations joining the pilot.
Catherine Blewett, Senior Development Manager
In the first year of the pilot we received over 40 applications, which was a great opportunity for us to test our processes and joint working arrangements to deliver a co-ordinated review and authorisation process. We have also been liaising closely with trial sponsors and Contract Research Organisations to gather feedback to improve the process and guidance documents on an ongoing basis. We recognise that it’s really important that any process which we implement for CTIMP submission and authorisation meets the needs of sponsors as well as those of the regulatory bodies, so this insight into the applicant perspective has been invaluable and we are incredibly grateful for the level of engagement.
The pilot will now continue, meaning more applications have an opportunity to benefit from a co-ordinated CTIMP review process.
The pilot has limited capacity, but we are keen to increase this as more organisations get involved. For this reason, we’re encouraging CTIMP sponsors who are interested in taking part, to contact us and register their interest.