February 2022: MHRA Consultation On Proposals for Legislative Changes For Clinical Trials

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.

January 2022: MHRA Proposal for Legislative Changes for Clinical Trials

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.

February 2022: UK HRA Combined Review Webinar Update

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.

December 2021: UK Update

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)

December 2021: Webinars for Transitioning to Combined Review

The HRA UK on December 22, 2021, has released an update for the Combined Review process.  They will be running a series of free, live webinars during December and January to provide an overview of upcoming changes and how they can affect individually the CTIMP applicants, sponsors, and NHS/HSC organizations depending on the role.

Bookings would be done online and the user needs to register for an account on the Learning Management System.

November 2021: Webinars for Combined Review

On 24 November 2021, HRA UK has updated that the Combined review will come into effect for all Clinical Trials of Investigational Medicinal Products (CTIMPs) from 1 January 2022. It was initially run as a pilot that started in 2018 under the name ‘Combined Ways of Working’ (CWoW) but from January 2022 it will be the only way to submit CTIMPs to MHRA and REC. Applications will be completed and submitted in the new part of IRAS.

To facilitate the transition there will be 3 webinars held-Combined Review as an Applicant, Combined Review for Sponsors, and Combined Review for NHS/HSC Participating OrganisationsThe webinars will provide an introduction to upcoming changes, help check the impact of the changes on the organization so as to update any internal processes/procedures as required thereof and provide guidance to available resources for further information and support.

November 2021: Make it Public Annual Report

As part of the delivery of the Make it Public strategy, the HRA has committed to producing an annual report to monitor how researchers are meeting their transparency requirements and what more the organization can to do ensure this is always the case. The first Make it Public annual report has been published for the same on 03 November 2021. The report summarises the transparency parameters in terms of registration of clinical trials, results reporting, informing participants, and sharing data and tissue.

HRA UK has partnered with ISRCTN registry to automatically register all UK clinical trials once they have received a favorable ethics opinion. It is stipulated to go live in 2022. Results reporting has been standardised by providing a  standard set of information to be reported when the research has been completed, including a confirmation that the results have been published. HRA and Medicines and Healthcare products Regulatory Agency are developing a process to share the summary of results collected in the final reports and they plan to track records to follow up with studies that have not yet submitted their end of study information. To keep participants informed, development is ongoing for a new guidance on how to inform participants about study findings and have necessitated Plain Language Summary (PLS) of the study findings to be submitted as part of the final report which is then published on their website. For their fourth pillar of transparency of sharing study data and tissue, platforms such as Wellcome Open Research is in place to allow organisation’s grant holders to rapidly publish all outputs from their research.

For the next phase in development of the transparency strategy a new transparency roadmap will be developed for researchers to see at a glance where they need to take action. The map would trace the study journey from the design and planning stage to completion of research.

 

 

October 2021: Combined Review Service for CTIMPs applications and IRAS Update

The HRA UK has released an update specifying that CTIMP applications via combined review must be submitted using a new part of the Integrated Research Application System (IRAS) and should not be started in the standard part of IRAS. Creating new applications using the standard IRAS system will be disabled from  14 December 2021.

An updated detailed guidance has been released for the step by step guide to using IRAS for combined review.  The guidance comprehensively covers the details required for the creation of an IRAS account, the roles, and tasks of IRAS users, the process of initial submission, and subsequent amendments.

October 2021: Protocol Registration in the UK

A recent update posted by HRA “New partnership guarantees full picture of UK clinical trials” focuses on achieving full registration of clinical trials in the UK.

As per the update posted, “Clinical trials will be automatically registered to guarantee a full picture of research taking place in the UK. HRA has partnered with ISRCTN, to make it easy for researchers to fulfill their transparency responsibilities. From 2022 the HRA will register clinical trials with ISRCTN, taking the burden away from research sponsors and researchers.”.

October 2021: EU Regulatory Update

The European Commission (EC) made available the Draft – Questions and Answers Document – Clinical Trials Regulation (EU) 536/2014 – Version 4.1 (September 2021) on October 14, 2021. This is not a final version and updated versions of the Q&A will be published progressively.

The questions and answers that are added or revised in this version are: 5.8, 7.39 (new), 8.4, annex II

  1. Section 5.8: This section has been updated to include more general information regarding protocol synopsis to be submitted with the clinical trial application according to Annex I D24
  2. Section 7.39: This has been added newly to provide information regarding anticipated date of annual safety report (ASR) submission under specific condition
  3. Section 8.4: Modified to include an additional point for information regarding the good manufacturing practice (GMP) compliance of the active pharmaceutical ingredients
  4. Annex II: Language requirements for part I documents was modified

Section 6 deals with submission of the results, and it is not affected by the current revision.