In a bid to put patient involvement at the heart of drug development and clinical trials, the Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a pilot programme to ensure that pharma companies and research teams harness the power of the patient voice.
Starting from 23 March, when submissions for new active substances and new indications are received, the applicant company will be expected to show evidence of the ways in which patients were engaged in the drug’s development.
During this exploratory stage of the pilot, clinical trials will not be asked to do the same but the MHRA will be logging any evidence of patient involvement in clinical trial applications in medical assessment reports to better understand the current extent of patient engagement activities.
During the pilot stage of the programme, providing proof of patient involvement will be voluntary and will not alter or hinder the outcome of applications.
The agency hopes a successful pilot will lead to patient involvement playing a more prominent role in its final assessment process, when clinical trials are approved or medicines are licensed.
“Patients are at the heart of everything we do,” said MHRA chief executive Dr June Raine. “Gathering this information will help us gain a better understanding of the current landscape and give us important insight into the valuable work being done across our innovative life sciences sector.
“I’m excited for the opportunity to learn more so that we can work together to shape the future of effective patient involvement and better outcomes for all.”
For the past few years, ‘patient-centricity,’ ‘patient engagement’ and ‘patient empowerment’ have become buzzwords within the industry. This pilot appears to be a step towards making patient involvement a regular standard rather than a sentiment or aspiration among drug developers and research organisations.
Health Research Authority (HRA) chief executive Professor Matt Westmore said: “The HRA welcomes this initiative from the MHRA to ensure that new medicines are developed in partnership with patients. It complements our own work to support and encourage everyone involved in the development of clinical trials to work with patients beyond just recruiting them as participants.
“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.”
The pilot will see the MHRA undertaking a detailed analysis of all evidence submitted and forms part of the UK’s wider vision for the future of clinical research, called the Future of UK Clinical Research Delivery.
“Clinical research is the backbone of healthcare innovation – it is the way we improve the prevention, detection, diagnosis and treatment of disease. Delivering this research depends on healthcare professionals from all backgrounds, working hand-in-hand with research participants, their families and their carers,” stated the report’s executive summary.
The documents outlined the UK Government’s ambitions to create a “patient-centred, pro-innovation and digitally-enabled clinical research environment, which empowers everyone across the NHS to participate in delivering research and ensures that patients from across the UK are supported to take part in research that is of relevance to them.
“Implementing the vision will unleash the true potential of our clinical research environment to improve the health of us all, to capitalise on our renowned research expertise and to make the UK one of the best places in the world to design and deliver research.”