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Call for a Centralised Professional Body for UK Clinical Research Sites

I have been thinking about holding this type of meeting for over 30 years! My roles in various research networks and interactions with regulatory frameworks have reinforced the need for a centralised body that can represent site management and clinical research organisations in the UK. In April, we arranged a roundtable with several industry leaders and Lord James O'Shaughnessy to explore the idea. 


By Dr Martin Johnson



This idea of the formation of a professional organisation to represent Clinical Research Sites/Organisations in the UK was born out of decades of fragmented operations and a vision nurtured since the late 1980s.  

 

Back then, as a general practitioner in Barnsley, I worked on numerous primary care studies, an experience that highlighted a significant lack of cohesion and standards across the industry in the country.  

 

This fragmentation not only hampered investigator collaboration but also restricted the evolution of research standards. It was in response to this challenge that I reached out in the early 1990’s to all pharmaceutical companies and Clinical Research Organisations (CROs) whose address I could find, proposing the creation of a primary care research group aimed at setting unified standards.  

 

The initiative was met with considerable support (70% responded), indicating a widespread recognition of the issue. The biggest British CRO back then, Innovex, offered to fund, and we set up IPCRG. 6 months later due to the acquisition of Innovex by Quintiles in 1996 IPCRG got swallowed up and our initiative hit a wall.  

 

Over the years, my roles in various research networks and interactions with regulatory frameworks have reinforced the need for a centralised body. The discrepancies in research protocol management between primary and secondary care, exacerbated by the inability of primary care researchers to contribute to these protocols, have often resulted in inefficient practices and sub-optimal patient care. 

  

Recent developments have added urgency to this cause. The Lord O'Shaughnessy report from last year pointed out the UK’s slipping global ranking in clinical trial initiation, which has plummeted from 4th to 10th place between 2017 and 2022.  

 

This decline calls for a proactive response to harness the capabilities of the private sector through initiatives like the Clinical Trial Accelerated Network. Such efforts could be significantly bolstered by formal incentives for GP referrals to research facilities, aligned with new guidelines that mandate physicians to inform patients about research options. 

  

The challenges are manifold. The protracted NHS R&D processes that affect everything from vendor setup times to patient care, highlight the need for a more streamlined and accountable system (though fortunately private research sites do not require this additional set-up). Furthermore, global trends, such as the reduction of principal investigators and the overall increase in study setup times, underscore the inefficiencies that a centralised professional body could address. 

  

The list of potential benefits from such a body is extensive: 

  

  • Standardisation of Research Practices: From training and PI appointment requirements to audit protocols, a unified approach could significantly enhance operational efficiency and research quality.  

  • Negotiation and Representation: A central body could serve as a powerful advocate in negotiations with regulatory authorities and other stakeholders, ensuring that the interests of research sites are adequately represented.   

  • Resource Management: Central purchasing of equipment and supplies could reduce costs and streamline operations.  

  • Breaking Down Barriers: Facilitating access to primary care networks and standardising processes like unblinding could enhance both patient safety and study integrity.  

  • Enhancing Transparency and Accountability: By fostering a more transparent interaction with bodies like the MHRA, such an organisation could ensure more reliable and timely communication regarding regulatory approvals and standards.   

  • Inclusion and Diversity: Addressing these important aspects could enhance the relevance and reach of clinical research, ensuring broader patient representation and access.  

  • Collaborative Policies with the NHS: A unified approach could streamline collaborations, benefiting both entities. 

 

The necessity of professional organisation is clear, as it would not only address immediate operational challenges but also pave the way for more strategic, collaborative efforts.  

 

While the task is daunting, the potential rewards in terms of enhanced research efficacy, improved patient outcomes, and a more robust research ecosystem in the UK are compelling. This meeting, therefore, is not just a call to action—it is a step toward realising a vision that could redefine the future of clinical research in the UK. 

 

 

About Lord James O'Shaughnessy 

 

Lord James O'Shaughnessy is one of the UK’s leading policy advisors. He has operated at the highest levels of government, including as a Minister at the Department for Health & Social Care, as Director of the No.10 Policy Unit, and as an advisor to DHSC Ministers during the COVID-19 crisis. James is driven by the twin goals of bringing life-changing health innovations to patients and growing the UK’s life science & healthtech industries.  

 

As Minister his responsibilities included implementing the Life Science Industrial Strategy, delivering a new pricing scheme with the pharmaceutical industry, chairing the National Genomics Board, and driving the digital transformation of the NHS. He was also responsible for preparing the health and social care sectors for Brexit and helping to design the post-Brexit regulatory regime. In 2021 James became co-founder and Senior Partner of Newmarket Strategy, a consultancy dedicated to improving access to health innovation by providing strategic advice and technical support to the healthcare, life sciences and health tech sectors. At Newmarket, James provides senior counsel to multinationals, SMEs, investors, universities, hospitals and charities, with a particular focus on technology, digital and data.  

 

He is a Visiting Professor at the Institute of Global Health Innovation at Imperial College, where he chairs the Data, Health & Wealth programme, and a non-executive director of both Health Data Research UK and the Albion Development VCT plc. Outside of health, James chairs the Repairing our Social Fabric programme at the think tank Onward and has a keen interest in education reform. 

 

 

About Dr Martin Johnson 

 

For many years, after devoting much of his time to Primary Care Research (as a GP for 30 years), Dr Johnson developed a specific interest in the management of chronic pain.  

 

He has been involved in Clinical Research for over 30 years and 250+ projects. He takes an active role in research being PI in multiple projects. He is a UK Medical Director at FutureMeds, where he has a specifically interest in pain management, vaccine development, Alzheimer’s research, asthma and new models of research. 

 

 

About FutureMeds   

  

Specialising in conducting clinical trials, FutureMeds is the 1st European Independent Dedicated DCT Site Network offering high levels of traditional and Decentralised Clinical Trial capabilities across the whole network and home nursing solutions in 18 European countries.  

 

FutureMeds is driven by a purpose to connect a global healthcare community and help bring quicker access to life-changing medications and therapies to all those who need them worldwide.  

 

FutureMeds’ Dedicated Research Site (DRS) teams serve as the company’s service foundation. DRS team’s capabilities help pharmaceutical companies and contract research organisations accelerate study timelines, streamline processes, lower costs, improve data quality and ultimately help speed up drug development and patient access to new treatments.  

 

FutureMeds @home, the company’s Decentralised Clinical Trial solution, provides pharmaceutical companies, contract research organisations and other partners with tools, teams & support, enabling them to simplify patient access to trials and boost recruitment, engagement and retention.  

 

Through its acquisitions, partnerships and a strategic focus on patient experience, FutureMeds brings opportunities to diverse European patient populations to participate in clinical research under the medical supervision of qualified physicians and health care professionals.  

  

  

Follow us on LinkedIn  

 

Follow FutureMeds on LinkedIn and join a growing group of engaged, passionate healthcare and pharmaceutical professionals who are on a mission to accelerate the drug development process and achieve regulatory approval faster so patients can safely access the very latest treatments as soon as possible. 

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