A more streamlined application process and quicker approval times are some of the best things about our Combined Ways of Working (CWoW) pilot – according to researchers attending a recent feedback workshop in London.
Health researchers from the pharmaceutical industry and the NHS took part in a one-day session to comment on their experiences of the pilot so far.
The CWoW pilot aims to improve the service being offered for the approval and ongoing management of Clinical Trials of Investigational Medicinal Products (CTIMPs).
It is being run by the Health Research Authority and Medicines and Healthcare products Regulatory Agency (MHRA), in collaboration with the Devolved Administrations.
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.
The pilot is also helping to prepare the UK for the future regulatory landscape.
More than 60 studies have now been approved via the CWoW pilot.
During the workshop, sponsors were asked to give feedback under four main sections:
- submission of the application
- Research Ethics Committee (REC) meeting
- requests for further information from the REC and MHRA
- guidance and document templates
100 per cent of attendees said the combined submission to the HRA and MHRA was preferable to separately submitting their applications to both regulators.
The 25 workshop participants also reported reduced overall time frames for approval, increased collaboration and convenience as benefits of submitting their research through the pilot.
We also received feedback on the benefits of telephone attendance at REC meetings and on how to make information and guidance for applicants clearer.
Following this feedback, we are now looking at refinements to the pilot that can be made before it is rolled out further. This will include:
- testing new scenarios to confirm that the system works well in these cases
- reviewing the information required for the REC and MHRA reviews and considering where the information should sit within the application dossier
- considering how we can ensure correspondence is sent to and received by the most appropriate people within a sponsor organisation
- developing guidance on common pitfalls to be avoided when submitting a CTIMP application.
We also plan to develop and publish guidance relating to common pitfalls to be avoided when submitting a CTIMP application.
The pilot is still open to applications, though capacity is limited. If you are interested in submitting, please email firstname.lastname@example.org.