New report: Embedding trials and building trust

Key insights

• Poor public trust forms a major barrier to improving representation and participation within trials.  
• Embedding trials within healthcare can normalise and simplify trial participation.  
• Public unease with the motives of clinical research can be assuaged by more transparent economic evaluations.  
• GPs and primary care physicians, who enjoy significant public trust, should be supported to facilitate patient participation in clinical trials.  

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The development of the UK’s clinical trialling ecosystem is dependent on growth in public trust, both within the trials themselves and the pharmaceutical industry as a whole, suggests a new report from independent think-tank PPP.

Embedding trials and building trust forms the second instalment of the Clinical Research Coalition (CRC) – a four-part series discussing how the UK can improve inclusivity within clinical trials and accordingly develop treatments with better efficiency and efficacy. The report outlines that while legislation has sought to address public concern with the sharing of data and to minimise the inconvenience of trial participation, there has been a paucity of action to grow trust within the clinical research ecosystem generally. Offering insight on the patient perspective, the report provides clarity to policymakers and trial organisers alike on the nature of public hesitancy around trial participation.   

Embedding trials and building trust discusses following areas of consideration for policymakers:  

• Communication, and how organisers can drive inclusion through plainly talking about the outputs and economics of clinical trials.  
• Relevance, and how embedding clinical trials within healthcare can allow trial organisers to build on the public trust in primary care networks – as well as creating opportunities to clarify where trialling fits into the overall provision of care to prospective patients.  
• Convenience, and utilising the principles of patient and public involvement to ensure that trial participation is minimally impactful on the lives of patients.  
• Data, and ensuring that the collection and sharing of data does not create a new barrier to patient engagement.  

Providing a section discussing each of the above themes, and noting insights from a cohort of representatives of regulatory bodies, academic clinicians, industry leaders, primary care leaders, population health experts and information technology experts, the report makes the following recommendations: 

• Researchers should regularly update their patient and public involvement strategies to enable maximal involvement in the design and implementation of trials. Clearly embedding, and highlighting, patient involvement will help to emphasise the value of trials to the public and improve relatability. These updates should adhere to the HRA’s Best Practice Principles for Public Involvement. 

• The sponsors of clinical trials should publish a plain language economic evaluation of their trial alongside any scientific/medical plain language summary. These briefings should be made available in a central location, such as clinicaltrials.gov.  

• Researchers and sponsors should seek to communicate to patients through primary care providers where possible, encouraging patients to increasingly view trial participation as a standard element of care provision.  

• Researchers and sponsors should seek to develop toolkits for primary care providers to support effectively communication with patients about trial opportunities. 

• Digital platforms that allow patients to engage with health services, such as the NHS App, should offer users maximal opportunity to see and select what data they share. Moreover, where possible, patients should be informed where, why, and how, their data is being used to support clinical research. 

The roundtable that served as the evidence base for this report was conducted in January 2022 and chaired by Dr Simon Kolstoe, a Reader in Bioethics (University of Portsmouth) and Independent Chair of both the Ministry of Defence Research Ethics Committee (MODREC) and the UK Health Security Agency’s Research Ethics and Governance Group (REGG).  

Commenting on the report and the ongoing work of the CRC, Dr Simon Kolstoe said: “Clinical trials are an essential part of producing new medicines, but not everyone is given the chance to participate. If barriers to participation are not identified and addressed, there is the very real risk that social inequalities will be turned into healthcare inequalities. In this report we highlight five practical recommendations that will help to embed trials into everyone’s healthcare and promote the trust that is needed to make trials more accessible, to more people.“

The CRC series is still ongoing and will conclude after the publication of a fourth report which will summarise the insights of previous reports and provide commentary from the representatives of several patient groups.  

Download the full report here.

 

For further information about PPP’s Clinical Research Coalition, please contact eliot.gillings@publicpolicyprojects.com.    

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Public Policy Projects (PPP) is an independent policy institute committed to global public policy reform. We bring together expert policymakers, stakeholders, academics and business leaders with a common interest in the future of public policy.  

PPP promotes policy reform through evidence-based research and ongoing analysis into healthcare, life sciences, environment, energy and international diplomacy. We promote a progressive, global and inherently liberal world view through a diverse portfolio of policy papers, publications, events and thought leadership.