The MHRA Delivery Plan | Becoming a World Leader in Clinical Trial Regulation

This blog was authored by Fiona Maini, global compliance and strategy principal, Medidata.

Last month, the Medicines and Healthcare products Regulatory Agency (MHRA) unveiled its Delivery Plan for 2021-2023, which aims to drive forward a new era in clinical trial regulation. The plan outlines the MHRA’s core ambitions of putting patients first, becoming a truly world-leading, enabling regulator, who protects public health through excellence in clinical trial regulation and science. It also draws on the findings of Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review (a review into how the health system responds to reports from patients about harmful side effects from medicines and medical devices), which is likely to lead to greater systematic engagement with patients and the prioritisation of patient outcomes.

In concrete terms, the MHRA has committed to creating new regulatory frameworks, developing the use of patient-reported outcome measures to make patient outcomes more central to clinical trials, and rolling out new patient engagement activities. This presents a bold and progressive outlook for the life sciences industry in the United Kingdom.

A Transformational Opportunity for EU Clinical Trial Regulation

This new two-year plan is a sign of the agency’s agility and ability to respond to two of the biggest challenges it has faced: Brexit and the COVID-19 pandemic. It has described the plan as a “generational and highly unique opportunity to deliver a new era and transform the organisation.” Despite the challenges it has faced over the past couple of years, the MHRA stands well-placed to deliver on this plan.

Following the UK’s departure from the European Union, the MHRA had to equip itself for a future outside of the jurisdiction of the European Medicines Agency (EMA). This presented the agency with the opportunity to showcase the UK as a world-class centre for research, with a regulator that can facilitate approvals and drive clinical trial innovation. Collaboration with international industry bodies will be one of the MHRA’s top priorities, and it must focus on maintaining its relationship with the EMA despite the fact that the UK is no longer part of the European Union.

The MHRA has also rightly highlighted its outstanding contribution to public health during the COVID-19 pandemic. The MHRA has demonstrated its flexibility and willingness to work alongside the industry over the past 18 months, as exemplified in the rapid progress of vaccine advancement in the UK, where clinical trials were accelerated to allow the development of a sound evidence base in record time. At the centre of the MHRA’s strategy is a commitment and desire to use the lessons learned from the pandemic to plan for the future and ensure that progress continues to be made.

Putting Patients First

The MHRA emphasizes “putting patients first” throughout the new delivery plan—a point that resonates strongly with our approach at Medidata. This represents a continuation of the work that the MHRA already does in this area, as patients have always been a central focus. For example, the MHRA has already established a Patient Group Consultative Forum, which currently has over 100 participants and provides a bridge between the public and the regulator.

The new plan has been developed with the needs of patients at the forefront. The fact that the MHRA will continue to consult patients as it implements all of the policies that it has outlined further highlights their commitment to delivering meaningful improvements to patients.

The MHRA’s philosophy of putting patients first is accompanied by an overhaul of the clinical trials system to provide patients with more flexibility and hopefully improve patient recruitment and retention—two of the biggest challenges still facing the industry. The commitment to a more innovative and pragmatic approach to clinical trials through an initiative to facilitate the uptake of novel trial designs should help encourage a shift away from more “traditional” clinical trials to remote or hybrid models. The pandemic has shown that we can effectively use technology to reduce patient burden by putting them at the centre of the trial and working in harmony with their daily lives, resulting in significant time, cost, and resource savings. Over the next couple of years, the hope is that this overhaul drives meaningful change in clinical trials and improves the overall patient experience.

Continuing to Innovate

The plan also recognises that the new Medicines and Medical Devices Act is an opportunity for the MHRA to further evolve the UK’s regulatory regime. During the pandemic, the MHRA was incredibly pragmatic in delaying the implementation of new regulation to let companies tackle the challenges that COVID-19 brought. It is pleasing to now see that the MHRA is addressing regulation and compliance with renewed vigour.

The MHRA has also recognised how beneficial its flexibility was during the pandemic and has included a commitment to “reduce regulatory burden by working with stakeholders to identify which flexibilities introduced in response to COVID-19 are safe to embed by Q3, 2021/22.” This highlights the MHRA’s willingness to adapt and work with the industry to develop solutions that work for all parties, while continuing to ensure patient safety. Although the timeline of Q3 2021/22 may look ambitious, the MHRA has the resources and the drive to stay on track and on time.

Overall, this new delivery plan exemplifies the MHRA’s commitment to becoming a world-leading regulator, with patient outcomes at its core. Underpinned by a patient-first approach, the industry looks forward to seeing how the strategy is implemented over the next two years—with the hope that it drives improvements across the clinical trial industry.