Clinical Trials: Combined Ways of Working
The MHRA and Health Research Authority (HRA) have been running a pilot scheme for the approval and ongoing management of Clinical Trials of Medicinal Products known as the Combined Ways of Working (CWoW) scheme. The CWoW streamlines the process by combining both the MHRA clinical trials authorisation (CTA) application and UK Research Ethics Committee (REC) application in a single submission. This allows for a reduction in the submission of duplicated documents, a single communication channel with the MHRA and UK REC, joint receipt of questions and approvals leading to a faster overall approval. The process aligns with the principles of the EU Clinical Trial Regulation 536/2014.
Experience to Date
Diamond has been assisting clients to navigate through the CWoW scheme for clinical trials being carried out in the UK. A feature of CWoW is to aim to have a joint decision from the MHRA and REC by day 60, and the statistics after the first year of the pilot claim that the average approval time is as little as 42 days. Diamond’s experience has been in keeping with this, highlighting the effectiveness of this new pilot scheme. The 7-day submission ‘window’ for CWoW submissions has been a useful tool in allowing clients to plan workloads effectively, and the 14-day deadline to respond to queries has been achieved. Diamond have been regularly attending CWoW update meetings and communicating directly with the CWoW team to ensure that we are at the forefront of the latest changes and updates, to allow us to provide our clients with up to date advice.
Latest Regulatory Intelligence
The scheme had been open only to applications by prior agreement, however, we understand from discussions with the MHRA during a recent Scientific Advice Meeting that CWoW will shortly be open to all applicants. However, this information has not been formally posted on MHRA or HRA websites.
[Authors: Lauren Phin, Alison Malcolm, Francois Rugiero and Maria Fernandez]