For a number of years now we have been working with the HRA (Health Research Authority), and in partnership with the Devolved Administartions of the UK, behind the scenes to explore opportunities to improve the services we provide to Clinical Trial Sponsors. Increased integration is beneficial irrespective of the future regulatory landscape.
The joint venture, between the MHRA and Research Ethics Service saw the birth of a pilot scheme, the Combined Ways of Working pilot (CWoW). The pilot has now been actively assessing live clinical trial applications since April 2018.
Under the CWOW pilot, UK organisations involved in the review and authorisation of clinical trials of investigational medicinal products (CTIMPs) are working more closely together and harmonising our assessment, producing a single UK decision on a clinical trial.
This is a huge change to the way clinical trials are currently assessed, which is very exciting!
The pilot process requires only a single CTIMP application dossier to be submitted for both the Clinical Trial Authorisation (CTA) and the Research Ethics Committee (REC) opinion. The application is jointly assessed by both organisations and any requests for further information are co-ordinated and combined. A single communication to confirm the final UK decision is sent to the applicant.
Only certain RECs are involved in this pilot at present, although the number involved is expected to increase as more applications are submitted into the pilot.
As the pilot has been progressing, both the MHRA and the HRA have been updating and improving our current processes to make sure they are aligned with the upcoming regulation. Part of the change will see both internal case management systems receiving a makeover with the goal being a seamless joint assessment and communication between the organisations and Sponsors.
It’s been a great opportunity to train our team members too. It also enables contract research organisations (CROs) and Sponsors to review their internal process and modify them in preparation for the new regulation, a ‘dummy run’ if you like.
I am delighted the pilot has really taken off. Thanks to all the Sponsors and CROs who have engaged with us and have been prepared to participate! We’ve found it incredibly useful.
Feedback from Sponsors and CROs has been extremely positive. The pilot offers the potential for quicker, more streamlined trial approval and hence faster trial start-up, a highly desirable prospect for all concerned.
How can we support you in preparation for the new regulation?
The Government has committed to align with the EU’s new Clinical Trials Regulation as far as we possibly can, without delay, when it does come into force in the EU (subject to usual parliamentary approvals).
Involvement with the pilot is a great way to make sure sponsor organisations are aware of and understand of the new ways of working and in particular, have an opportunity to reflect on future internal changes they may need to start to consider. For example, we are aware that some sponsor organisations have different departments dealing with the CTA and the REC submissions. As the CWoW involves the submission of one application dossier for both the CTA and the REC, this may need to be managed differently in the future.
Involvement with the pilot will help sponsor organisations to understand possible changes and any potential impact. While this is currently a pilot scheme, we expect that the process which is being developed will be implemented for all CTIMPs in the future.
We also hold fortnightly teleconferences that you can join to keep up to date with the pilot and we can provide you with guidance documents too.
Interested in joining the CWoW?
To find out more about the pilot and how to get involved please see the guidance on the HRA website or email cwow.admin@nhs.net and include ‘combined ways of working pilot’ in the subject line.
Lessons learnt?
Working together is more efficient than working apart. We can learn from each other and in doing so make sure our messages to you are clear and simple.
We are all striving for the same thing, the seamless approval of safe clinical trials in the UK.