The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that it will soon launch a public consultation on changes to the UK legal framework for clinical trials, which could result in greater transparency and increase patient involvement.
The consultation, which the MHRA confirmed was imminent to The Pharmaceutical Journal on 12 January 2022, may also include a proposal for a legal requirement to publicly register clinical trials before they begin and to publish a summary of results in a “timely manner” after they end.
In a written parliamentary answer on 11 January 2022, George Freeman, minister for science, research and innovation at the Department for Business, Energy and Industrial Strategy, said the proposals would help make the UK “the best place to research and develop safe and innovative medicines”.
“We have the opportunity to improve our regulation to support clinical trials in the best interest of patients, in line with the ambitions of the Life Sciences Vision, to make the UK the leading global centre for innovative research design and delivery, across all types and phases of trials.”
Freeman said the aim of the legislative proposals outlined in the consultation was to “streamline” clinical trials approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality and promote patient and public involvement in clinical trials.
In a blog published on 21 December 2021, the MHRA said that current UK legislation was “silent” on transparency requirements, but that the Medicines and Medical Devices Act 2021 (which became law in February 2021) provided an opportunity to design a regulatory environment for clinical trials that would support the development of innovative medicines and ensure that the UK remains a favourable base for life sciences for the benefit of UK patients.
The blog said: “We have been working with stakeholder partners, including patients, to develop proposals for public consultation. This includes introducing a proposal for a legal requirement to register a trial in a public register prior to its start and to publish a summary of results in a timely manner, i.e. 12 months following the end of the trial (unless otherwise justified and authorised).”
The article added that, to ensure that the protection of clinical trial participants remained “at the heart” of legislation, the MHRA would also consider introducing a requirement to make information about the outcome of the trial available, in a suitable format, to participants “within a timely manner”.
“We are also considering what appropriate sanction legislation could offer to drive registration and reporting.”
The MHRA said it would provide further information on the consultation launch date in due course.