Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of (a) the reasons for trends in the level of patients participating in clinical trials in England since 2018 and (b) the impact of financial incentives to GPs to enrol patients in clinical trials on levels of participation; whether he has had discussions with the (i) British Medical Association and (ii) Royal College of General Practitioners on this matter; how the amount paid per patient enrolled onto a clinical trial will be calculated; and whether measures will be put in place to ensure (A) patients (1) are able to give and (2) have given fully informed consent and (B) vulnerable patients are protected.

Overall, there has been an increase in the number of participants recruited to clinical studies in England since 2018. During the COVID-19 pandemic, recruitment to studies on the National Institute for Health and Care Research (NIHR) Clinical Research Network (CRN) Portfolio increased by 90% to an average of over 115,000 participants recruited per month in 2020/21. During the pandemic, many non-COVID studies were paused to focus on nationally prioritised COVID-19 studies. The Department, working in partnership with NHS England, has taken action to recover the UK’s capacity to deliver research through the Research Reset programme. By May 2023, a rolling average of over 77,000 people were recruited to studies on the NIHR CRN portfolio, 10,000 more than the monthly average prior to the pandemic in 2019/20.

In February 2023, the Government commissioned an independent review to offer recommendations on how to resolve key challenges in conducting commercial clinical trials in the UK and transform the UK commercial clinical trial environment. The Lord O’Shaughnessy Review, published in May 2023, highlights the opportunities for primary care to deliver population-scale trials. A comprehensive response will be published in the autumn covering decisions on the recommendations not covered in our first step, including financial incentives for general practitioners (GPs) to take part in commercial trials. We will seek input from stakeholders as we make our assessment.

Payments to GPs for involvement in clinical research delivery are based on standardised costing methodologies supported by NHS England and NIHR CRN to provide transparency and reassurance that there are not undue incentives to GPs or other health professionals, or inappropriate personal financial gain.

All clinical trials are reviewed by a Research Ethics Committee (REC) prior to the research starting. All RECs in the UK are recognised as meeting the standards set out in legislation. RECs consider the method of seeking consent and the information that is provided to potential participants, including those that may be vulnerable, to ensure that they are appropriately informed and able to make a choice about participation.