The HRA and the Medicines and Healthcare products Regulatory Agency (MHRA) will hold a workshop in London next week to get feedback on the Combined Ways of Working (CWoW) pilot.
The workshop, which is fully booked, is for sponsors and Contract Research Organisations (CROs) that are participating in the pilot, and will help to develop the pilot further as we look to encourage more applications through the scheme.
The CWoW pilot, run by the HRA and the MHRA, in collaboration with the Devolved Administrations, aims to improve the service being offered for the approval and ongoing management of Clinical Trials of Medicinal Products (CTIMPs).
The process requires only one CTIMP application dossier to be submitted for both the Clinical Trial Authorisation (CTA) and the Research Ethics Committee (REC) opinion.
Applicants then receive a combined communication to request any further information required and a single communication to confirm the final decision.
This increased assimilation is seen as a positive step forward and sponsors submitting applications under the pilot have reported reduced overall time frames for approval.
The workshop will look at the pilot so far including the current process, the application dossier and the guidance in place to support applicants.
Catherine Blewett, Senior Development Manager, Health Research Authority
The Combined Ways of Working pilot is a more streamlined and co-ordinated process for the review and approval of drugs trials in the UK, and over 50 studies have now been approved since the pilot began over a year ago.
This workshop will gather feedback from sponsors and CROs in relation to the new Integrated Research Application System (IRAS) which is currently being developed for CWoW, and the CWoW pilot more generally.
The outcome of the event will help the MHRA and HRA to develop the pilot further. We are keen to make sure the process works well as more commercial and non-commercial sponsors join the pilot.