In Conversation with Gary Quashie, OPIS: The Evolving Clinical Trial Landscape in the UK
The UK’s clinical trial landscape has undergone significant changes in recent years since Brexit and, the COVID-19 pandemic, driven by a push from the government to boost the country’s economy by attracting more pharmaceutical investment.
We spoke with Gary Quashie, who has now helped over 100 biotechnology & medical device companies with their clinical, commercial, and regulatory strategies across UK, EMEA and US. He explained how the UK government commissioned a comprehensive review in early 2023 led by former health minister James O'Shaughnessy to examine the state of the UK clinical trials market. The review consulted with industry experts and stakeholders before making 27 detailed recommendations that regulators like the MHRA and organizations like the NHS, HRA, and NIHR are now acting on.
Some of the most impactful changes being implemented include reducing commercial trial approval timelines to 60 days (initial submission review + post amendment review), implementing more coordinated national contracting and standardized processes to accelerate study start-up times, and leveraging real-time data to increase transparency for patients and research networks.
UK regulators have also introduced more flexibility in the clinical trial application process. Since 2021, applicants have seen more leeway to request additional time to respond to regulators’ requests for amendments or clarifications. Gary explained how there was a period where Biotech leaders expressed how they’d experienced delays in approval processing timelines, but the MHRA has worked hard to address previous staffing bottlenecks and their announcements now forecast continued improvements in approval timelines. For example, performance reports show that between July and October 2023, the MHRA approved 2,000+ clinical trial applications within the 60-day target. With continued improvement during the Christmas period moving into 2024.
The growth of real-world evidence and decentralized trial designs have likewise strongly influenced how CROs like OPIS, who have 25 years experience in running over 1,500 clinical trials, approach running studies. Gary emphasized the value of gathering real-world data to provide patients more information about managing their own health and wellbeing, which in turn encourages patient retention. He said OPIS leverages learnings from FDA guidance and extensive stakeholder input on best practices for enrolment, screening, remote monitoring, and data security for decentralized trials. OPIS has also proactively embraced delivery methods like microneedle patches and oral therapeutics that are well-suited for decentralized approaches.
Gary comments that a hybrid approach combining virtual and on-site elements is often optimal for maintaining patient engagement in trials. He pointed to Apple's ResearchKit as an example where lack of physical support led to very high drop-out rates. OPIS has set up clinical.net and processes to address key considerations like supplies, logistics, product handling, and biosafety oversight for decentralized trial designs.
Looking ahead 3-5 years, Gary would first and foremost like to see more community engagement in the UK to build greater public trust and awareness around clinical research. He suggested more small grants and incentives be made available to community leaders, advocacy groups and volunteers to develop grassroots programs promoting education and active participation in trials.
Gary also stressed the critical importance of focusing on diversity, equity, and inclusion in trials, noting that representative participant populations are essential for sound scientific results. He cited initiatives in the US like the proposed DEPICT Act that have catalysed more open discussion in the industry about the need for diverse, inclusive trials.
While tremendous progress has been made, challenges remain. The UK should continue efforts to position itself as an attractive global destination for clinical research across therapeutic areas now and in the coming years. But doing so in a way that prioritizes boosting engagement, transparency, and tangible benefits for diverse patient populations must remain a priority amidst the focus on speed and efficiency. Regulators and industry leaders will need to collaborate closely to strike this delicate balance.
If the UK can succeed in these goals, it will not only strengthen its international reputation in life sciences, but also build greater public trust by showing that when done right, clinical research is an innovative and efficient way to put patients first and support the healthcare ecosystem.
OPIS will be at COG UK, taking place on the 20th & 21st February 2024, in London. More information can be found here: https://www.thepbcgroup.com/cog-uk
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