Euro Roundup: MHRA pilot seeks evidence of patient involvement in R&D

RoundupsRoundups | 25 March 2021 |  By 

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has begun a pilot project to encourage patient involvement in drug development, asking companies that seek approval for new active substances and new indications to provide evidence of “patient involvement activities they undertook when developing their product.”
For now, the project is focused on gathering information. Applicants can choose whether to provide MHRA with the requested information, which for now will have no effect on the outcomes of submissions. MHRA wants to better understand the roles patients are playing in drug development currently so it can work with other stakeholders to shape their involvement in the future.
In the longer-term, evidence of patient involvement could play a bigger role in the approval process. “The agency hopes that a successful pilot will lead to patient involvement playing a greater role in the final assessment process, when clinical trials are approved, or medicines are licensed,” MHRA wrote.
Clinical trial applications are excluded from the pilot project “at this early exploratory stage,” according to MHRA, which will “be documenting in medical assessment reports if there is evidence of patient involvement in clinical trial applications in order to better understand the current scope of activities.”
Matt Westmore, chief executive of the UK Health Research Authority (HRA), expressed a desire for patients to play a bigger role in the development of clinical trials, rather than just be participants in the studies.
“This is crucial to ensure that studies are relevant, important and acceptable to take part in, so that high quality research can improve people’s health and wellbeing. It is also more fundamentally just the right way to do research – it is about patient voice and patient power in the system,” Westmore said.
MHRA Notice

UK puts accelerated approvals at heart of plan for streamlined clinical trials

The UK aims to be seen as “the best place in the world to conduct streamlined, efficient and innovative clinical research” through actions including accelerated regulatory approvals, according to a policy paper from the UK government.
With the UK’s separation from the European Union granting it greater flexibility over how it handles clinical trials, the government has set out a plan for how research will be delivered in the future. The policy extends well beyond how clinical trials are regulated, for example by covering how to embed research delivery in the healthcare service, but also addresses how MHRA and other authorities can move the UK toward the goals.
The proposals with regulatory implications include a focus on improving the speed and efficiency of study start-up. Officials want to accelerate costing, contracting and approvals. Parts of the plan are designed to prevent delays, but the government also wants to actively speed up approvals, citing the HRA’s ethics review pilot for global clinical and phase I trials as an example of a practical action. HRA is aiming to halve the time taken to approve research applications.
While changes to processes may be needed to achieve some goals, the government thinks there are opportunities to improve clinical research within the existing regulatory framework. That viewpoint is based on the experience of the “rapid set-up and delivery of platform trials” to assess treatment for COVID-19.
“This has all been achieved within existing regulations and guidance and without loss of rigour,” the authors of the report wrote. “The secret has been flexibility, collaboration and innovation in research design, set-up and delivery. We need to carry this approach through into the future of all clinical research, with everyone making use of new and innovative approaches and by working together across research sponsors, regulators, government and the NHS, to support rapid set-up and delivery.”
Policy Document

MHRA tweaks guidance on registering clinical trials and submitting results

MHRA has tweaked its guidance on applying to run clinical trials and managing authorized studies. The revised sections address the registration of clinical trials and submission of summary results.
In the guidance on applying to run studies, MHRA explains the clinical trial authorization process. Most of the document, which was first published in 2014, is unchanged from the version released at the start of the year, but MHRA has altered its advice on what sponsors should do if they lack the registry numbers at the time they are preparing their applications.
The old guidance said sponsors should email MHRA the information “before the first participant is recruited and no later than six weeks after recruitment of the first participant.” MHRA has clarified its position in the updated guidance, stating that applicants should send the details within six weeks of recruiting the first participant. The updated guidance also asks sponsors to inform the Research Ethics Committee of the registration number “as soon as possible.”
MHRA updated the guidance on the same day as it revised its advice on managing clinical trials. The update focuses on the timeframe for submitting a summary of clinical trial results. The old guidance gave sponsors six months to post results for pediatric studies and 12 months to share the findings of all other clinical trials. The revised guidance lacks the reference to the pediatric timeline, although a document focused on research in children still includes the six-month timeframe for reporting.
Application Guidance, Reporting Guidance

Swissmedic reveals new structure of veterinary medicinal product information

The Swiss Agency for Therapeutic Products (Swissmedic) has published the new structure of veterinary medicinal product information, in an effort to harmonize its structure with that of the EU.
After enacting the changes, Switzerland will provide medicinal product information in two parts, one aimed at healthcare professionals, and another designed for lay people. Swissmedic said it “attaches particular importance to the comprehensibility by lay people of the package leaflets for pet medicines in order to help the animal owners use them correctly.”
Some products will only need to come with information designed for one of the audiences. Other changes include the inclusion of a structured breakdown of clinical and preclinical information.
The first texts created in compliance with the new structure are now available but Swissmedic expects it to take until the end of 2024 to complete the harmonization of the documents for all authorized veterinary medicines.
Swissmedic Notice

Finland discusses progress of clinical trial evaluation pilot project

The Finnish Medicines Agency (Fimea) has completed the first clinical trial evaluation under a pilot program intended to prepare it for an upcoming change in EU regulations on human research.
Fimea is evaluating studies accepted into the pilot under the current legislation but the assessment procedure and processing times are taken from the EU Clinical Trial Regulation. Participation in the pilot could help Fimea and clinical trial sponsors to prepare for the new regulations, which Fimea expects to take effect in January.
Outi Konttinen, secretary-general of the National Committee on Medical Research Ethics, said there has been “commendable interest” in taking part in the pilot. "Two studies are currently being piloted and, additionally, we have already made a preliminary decision on the other two studies to be piloted. We welcome new applications as well,” Konttinen  said.
Fimea Notice


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