A pilot project that puts patient involvement at the
heart of clinical trials and medicine development has been launched
by the Medicines and Healthcare products Regulatory Agency
(MHRA).
From today, when new applications for selected medicines (new
active substances and new indications) are received, the
applicant company will be asked for evidence on the patient
involvement activities they undertook when developing their
product. For clinical trials, whilst additional information won’t
be requested at this early exploratory stage of the pilot, the
MHRA 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.
In considering how patient involvement is integrated into the
approvals process, the MHRA hopes to learn from any
patient-related activities that take place during development,
and use this knowledge to improve the quality of clinical drug
development and health outcomes in the future.
During the pilot, the information provided by the applicants will
be voluntary and will not alter the outcome of their application.
However, in future, 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.
Patients are at the heart of everything we do. 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.
Professor Matt Westmore, HRA Chief Executive, adds:
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 Agency will undertake a detailed analysis of the evidence
submitted.
This crucial patient-focused pilot supports the ambitious vision
of The Future of UK Clinical
Research Delivery, launched today. As a partner, the MHRA is
proud to be part of strengthening and contributing to this
project.
