The HRA and Medicines and Healthcare products Regulatory Agency (MHRA) have been exploring opportunities to improve the service being offered for the approval and ongoing management of Clinical Trials of Investigational Medicinal Products (CTIMPs).This combined ways of working pilot brings together the two organisations’ regulatory approvals, streamlining the process in a way that would fit with the EU’s new Clinical Trial Regulation.
PRA Health Sciences and Quotient Sciences have both been part of the pilot. Professionals from these organisations describe their experience of submitting applications through the new process below.
Quotient SciencesIt’s great to have a more joined up approach from the regulators. The interaction and co-ordination between the REC and the MHRA works really well.
PRA Health SciencesOverall we have seen a significant decrease in MHRA and REC approval timelines which has been welcomed by our clients; the pilot process was straightforward and fitted well into PRA’s established processes.
The pilot process requires a single CTIMP application 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 timeframe for responding to requests for information from ethics is reduced to 14 days under the combined ways of working process; something we recognise was a challenge for some sponsors.
PRA Health SciencesOne change to the usual approvals service is the 14-day window for updating applications in response to requests for further information from the regulators. The pilot is also developing guidance around clinical trial amendments, which will be important if the combined approval system is launched.
Quotient SciencesCombining parts of the approval process removes some of the minor comments that would have been received outside of the pilot. The change to the 14-day turn around for responses to queries about applications is more than manageable, and we’ve found that timelines from submission to approval have actually been much shorter.
PRA Health SciencesIn terms of submitting applications, the guidance instructions are clear and well written. There is also a handy checklist for submission which people found useful.
The pilot is ongoing and is being rolled out to more RECs each month, giving a greater number of booking options for sponsors looking to be allocated to a specific meeting.
Quotient SciencesWe’re always interested in how we can reduce our timelines, and as more RECs become involved in the pilot, allocation to meetings will become more flexible, speeding things up further.
PRA Health SciencesOne benefit of the pilot is that it has been a very positive advert for clinical research in the UK; PRA work with sponsors Globally and many of them have been keen to get involved in this new approach which streamlines the process for the benefit of all parties.
We’ve moved past the pilot and all CTIMP applications should now be created in the new part of IRAS and submitted via our combined review service.
Find out more about submitting via combined review (link: Combined review - Health Research Authority (hra.nhs.uk). If you’re a first time user, please contact our team at cwow@hra.nhs.uk for help and support getting started.