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.
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.
- Changes are applicable only to the new part of IRAS, for applications submitted through combined review.
- Every project in the new part of IRAS must have a Chief Investigator (CI) and a Project Deputy.
- 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.
- 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.
- Changes made by people with edit access will be stored once saved.
- 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.
- The email correspondence about the project is only sent to the contact listed in question C1.
To view the full video, click here.
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.
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.
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.
In February 2022, the MHRA has released a consultation page for users to submit their responses online to their eight weeks of public consultation for the UK clinical trial legislations.
It accommodates for the submission of responses in a ‘Yes or ‘No’ format along with a justification for three important transparency-based questions in the proposal. Questions involving the requirement in their law for registering trials, summary results posting within 12 months of the end of the trial, and sharing trial findings with participants.
On January 28, 2022, UK HRA posted an update regarding the changes to the deferrals process and automatic registration of a research summary on the HRA website.
From January 31, 2022, the rules around deferring registration and publication of a research summary on the HRA website will change. Below are the changes that will be applicable from January 31, 2022 onwards:
- Publishing limited information: As opposed to the previous process where a deferral from registration of all information was provided, the sponsors will now need to publish a minimum record of the clinical study on a publicly accessible registry if a deferral is agreed by the authority.
- A new maximum timeline: A maximum deferral period of 30 months will be applicable for all deferral requests approved from January 31, 2022, onwards. The initial deferral will still last for 12 months. Sponsors can apply to extend the deferral period by 12 months at a time until the study comes to an end. An extension for another 12 months and then up to a further 18 months can be applied for, by the sponsor (a maximum of 30 months in total from the end of the study).
- How to request a deferral: Trials using combined review can submit a deferral request in the new part of the Integrated Research Application System (IRAS) by answering the deferral question in part C of the study information question set. For all other studies, deferral can be requested by emailing [email protected] Further information on requesting a deferral can be found here.
Update on automatic registration: HRA had started with automatic registration for all new clinical trials of medicines that gained approval through the combined review process since January 01, 2022. Trials submitted through combined review after January 01 that are given approval, are being registered in the ISRCTN Registry.
Automatic registration applies to clinical trials of investigational medicinal products (CTIMPs) and combined trials of an investigational medicinal product and an investigational medical device (IMP/device trials). These trials will be automatically registered once all approvals are in place (HRA/Research Ethics Committee and MHRA approvals) at no cost to the applicant by the authorities. More information related to automatic registration can be found here.
On 17 January 2022, MHRA UK launched eight weeks of public consultation for the UK clinical trial legislations. The proposal invites views on various parameters including research transparency and the clinical trial approval process.
In line with the Make it Public strategy, proposal for a ‘requirement’ in the legislature for trial registration, summary results posting within 12 months of the end of the trial, and sharing trial findings with participants have been discussed. Views on the response and timelines to MHRA queries, decisions, and other responses applicable as per the newly introduced Combined Review have also been called for. Detailed guidance can be accessed here.
On January 15, 2022, HRA announced the Combined review webinar on upcoming changes is now open for booking. All applicants, sponsors, and NHS/HSC participants can apply on various dates between February and March 2022 via their Learning Management System (LMS). The webinar will be recorded and a version will be made available for anyone who cannot attend a live session.
The webinar will provide an introduction to the upcoming changes, the impact of these changes on the organization, and any internal processes or procedures that might need to be updated and provide guidance for available resources providing further information and support.
Changes to the Rules on Deferring Research Registration and Publication
On 24 December 2021, UK HRA published a new maximum timeline for deferrals. Deferrals have a validity of 12 months and applicants request their extension for deferral every 12 months. Under the new policy, this will be a maximum of 30 months after the study ends. When the deferral ends the research sponsors are required to add full information onto the registry, along with the summary of results which will then be published on the HRA website. Trials not deferred are registered on the ISRCTN registry automatically.
For clinical trials where deferral is approved, researchers are yet required to upload reduced information in an approved registry. For deferrals approved after 31 January 2022, the minimum information expected to be published on a registry is available here-Research registration and research project identifiers – Health Research Authority (hra.nhs.uk)