The Medicines and Healthcare products Regulatory Agency is playing a fundamental role helping to ensure that the UK remains one of the best places in the world to deliver safe, cutting-edge research. Part of this work is the recently-launched combined review service for all new Clinical Trials of Investigational Medicinal Products (CTIMPs), which provides a more streamlined and efficient service for research applicants.
For those who haven’t heard the news, since the first of January the combined review offers a single application submission route and a co-ordinated review for all new CTIMPs, resulting in a combined regulatory and ethics decision on a clinical trial. Applicants just need to do a single application, thus facilitating rapid start up and potentially benefitting patients sooner.
Building on this, we are testing a new process as part of our vision to improve the speed and efficiency of clinical research approvals. We are calling on sponsors, research organisations and investigators running studies involving both a medicine (a clinical trial, CT) and a medical device (a clinical investigation, CI) to join our CT/CI coordinated assessment pilot and contribute to develop a new streamlined route within the combined review journey.
The call for expressions of interest is open. Join the pilot today and contribute to potentially changing the application process of clinical research involving both a medicine and a medical device. By doing so, you will be supporting the UK-wide ambitious vision of The Future of UK Clinical Research Delivery.
The benefits of joining the CT/CI PiIot Programme
Benefits for sponsors, research organisations and investigators include:
- a single submission for Clinical Trial Authorisation and Clinical Investigation Application
- a co-ordinated review process by the Medicine and Device divisions of the MHRA, as well as the Research Ethics Committee (REC), under the same aligned timeframe
- combined communications to request further information
- helping to drive the development of a new combined process
To join the pilot, you must have a trial involving both an investigational medicinal product (a clinical trial, CT) and a medical device (a clinical investigation, CI).
The pilot excludes applications for any Advanced Therapy Investigational Medicinal Products (ATIMP) or First Time in Human studies with novel compounds that requires Expert Advisory Group (EAG) review.
If your study meets the criteria and you would like to express your interest in joining the pilot programme to benefit from the joint CT/CI assessment procedure, please email email@example.com with the subject line CT/CI pilot.