June 2022: ISRCTN Registry Update

The ISRCTN Registry has recently updated its display of study records for making compliance tracking easier, and to encourage trialists to follow transparency recommendations. Registry records now display green badges to highlight prospective registration, regular updating of ongoing records and posting protocols, statistical analysis plans (SAPs), data links, and results to the record.

April 2022: Combined Review – New Video Explains IRAS User Roles and Recent Changes

On 06 April 2022, HRA UK posted on its website, a short, animated video to explain how the different roles work in IRAS for combined review and the permissions each has in the system.

The clip focuses on collaborators, covering recent changes to IRAS for combined review of a CTIMP or combined CTIMP and device project.

  1. Changes are applicable only to the new part of IRAS, for applications submitted through combined review.
  2. Every project in the new part of IRAS must have a Chief Investigator (CI) and a Project Deputy.
  3. Now, all collaborators can have edit access in the system. Moreover, collaborators can now book the Research Ethics Committee (REC), respond to requests for further information (RFIs), create amendments or reports and provide end of trial notification.
  4. If the project is not yet authorised, all collaborators will have been upgraded to unlimited edit access. If the project has been authorised, all collaborators will be removed automatically by the system when this change is made. The Project Deputy or CI will need to re-add the collaborators.
  5. Changes made by people with edit access will be stored once saved.
  6. The person that sends the project to the Sponsor will receive the tasks in the system to book the REC, and then to respond to any RFIs, if needed.
  7. The email correspondence about the project is only sent to the contact listed in question C1.

To view the full video, click here.

March 2022: The Draft UK Resolution: Strengthening Clinical Trials to Improve Public Health

An article, “UK proposes global effort to strengthen clinical trial transparency” has been published on 30 March, 2022, on TranspariMED.

On 30 March 2022, an original draft resolution text by the United Kingdom – ‘Strengthening Clinical Trials to Improve Public Health’ was made available online. The UK will make a proposal at the 75th World Health Assembly (WHA) to be conducted between 22-28 May 2022, to improve clinical trial quality and conduct globally.

The following steps pertaining to clinical trial study design, registration, and results posting are proposed in this draft:

  • Ensuring new trials are not duplicative, are of sufficient size and appropriate design
  • Introducing grant conditions for funding clinical trials to encourage the use of standard data protocols and to mandate registration on a clinical trial registry within the World Health Organization’s International Clinical Trials Registry Platform (ICTRP)
  • Establishing mechanisms to secure a commitment from researchers to share pre-publication results with regulatory bodies
  • Establishing mechanisms to ensure the results of clinical trials are reported in a timely manner following primary study completion, including through registering the results on a clinical trial registry within the ICTRP, and encouraging timely publication of the trial results ideally in an open-access publication

Additionally, the draft requests the Director General of the WHO to develop a global action plan for implementing the principles of this resolution and to present the draft action plan for consideration by the 76th World Health Assembly in 2023.

Download the full text of the UK draft resolution here.

March 2022: Changes to Automatic Registration

On 25 March 2022, HRA UK posted an update regarding the changes to the process of automatic registration for clinical trials of investigational medicinal products (CTIMPs) and combined investigational medicinal product and a medical device (IMP/device) trials submitted through combined review. If a trial approved through combined review is or will be registered on ClinicalTrials.gov, sponsors can request not to be automatically registered with ISRCTN Registry. Until 31 March 2022, if the sponsors have registered or plan to register on ClinicalTrials.gov, they must notify HRA via email [email protected].  From 31 March 2022, sponsors can specify this in their IRAS application.

Both ClinicalTrials.gov and ISRCTN will feed in to Be Part of Research if UK locations are included, bringing the goal of having a full record of all UK clinical trials in one single place closer.

More information regarding the updated process can be found here.

March 2022: Phase 1 Review Timelines and Seven-day Submission

On 04 March 2022, HRA UK posted an update regarding the review timelines for Phase 1 studies. Many Research Ethics Committees (RECs) will accept the submission of Phase 1 applications up to 7 days before the REC meeting date. To make a request for seven-day submission for an application, sponsors should contact their preferred REC which is flagged to review Phase 1 clinical trials.

As per the Phase 1 application process, the coordinated initial outcome from the MHRA and REC will be issued together within 7 days of the REC meeting. The aim is to deliver ethics opinions for Phase 1 clinical trials within a short timeframe, while maintaining robust ethics review.

More information related to Phase 1 application process can be found here.