The UK government will now make changes to the law that underpins how clinical trials are regulated in the UK following a public consultation. There were over 30 proposed changes made in the consultation, most of which are being taken forward, some with minor amendments. Below, we highlight a few areas that we think are important to note and are likely to be relevant for clinical trials for rare conditions.
One of the original proposals from the consultation was around introducing a legal requirement for the design of clinical trials to have involvement from people with relevant experience such as a patient, family member or carer.
Involving people with a lived experience of a condition in the design of a clinical trial is a vital step towards making clinical trials more patient centered. The importance of PPI was acknowledged in the response to the consultation and it has been decided that instead of introducing a law that requires PPI, the MHRA will be producing a guidance document that highlights best practice. This is because a law around PPI was considered to potentially be too restrictive and encouraging PPI through guidance allows for a much more flexible approach towards involving patients in clinical trial design and other stages of the clinical trial process. We support this choice.
Improving diversity of clinical trials
Ensuring that a cohort being studied as part of a clinical trial is representative of the wider population is important in addressing health inequalities.
The consultation response states that instead of introducing legislation to support diversity in clinical trials, it will be encouraged via a guidance document. This is because requiring a certain level of diversity in clinical trials could inhibit some areas of research as it may not always be appropriate to have an equal distribution of ethnicities and/or genders in a trial population. For example, there are some conditions that affect certain ethnic groups more than others and genetic conditions that are inherited in an X-linked recessive pattern are likely to impact more males than females.
Improving information sharing
A few of the proposals that are being taken forward that aim to improve information sharing include the introduction of legislation that requires a clinical trial in the UK to be registered publicly. Currently this is only recommended as best practice, although most trials are publicly registered as part of their approval process, however this will formalise this expectation and improve the availability of information about ongoing clinical trials in the UK.
There will also be legislation that requires a summary of the clinical trial results to be published within 12 months after a trial has ended and to share these results with the trial participants in a suitable format. This is a positive step towards improving the transparency of clinical trials and ensures that the results are publicly available for everyone to benefit from.
Visit the government website for more information and a full list of all of the changes that the UK government plans to make on the laws regulating clinical trials. If you’d like to discuss this further with our policy team, please email email@example.com