New recommendations to promote equity, diversity and inclusion in decentralised clinical trials

More patients from underserved communities could join and benefit from clinical trials, thanks to a set of new recommendations developed by a Birmingham-led international research group. The eleven recommendations, aiming at enhancing equity, diversity, and inclusion in decentralised clinical trials, have been published today in Nature Medicine.

Decentralised clinical trials (DCTs) involving the use of digital tools to facilitate remote research have become increasingly common, especially after the COVID-19 pandemic. These innovative trials facilitate virtual interactions between clinical trial teams and participants by making it easier to collect, transfer, and store electronic data. While DCTs can make it easier for more individuals to participate in clinical trials, they also present several challenges which may create or worsen existing health inequalities and limit the generalisability of results.

For example, they can exclude already underserved populations who do not have access to the internet, possess electronic communication devices, or have low digital literacy levels. Adherence to the use of digital health technologies can also be a challenge, particularly for older or disabled patients whose cognitive or physical issues may make it difficult to remember or action the steps required to operate the devices.

To address these barriers, researchers from the Centre for Patient Reported Outcomes Research (CPROR), NIHR Birmingham Biomedical Research Centre (BRC) and Applied Research Collaboration West Midlands at the University of Birmingham convened an international group of academic researchers, trialists, public contributors, regulatory and industry experts and developed a set of recommendations for sponsors, trial delivery teams, and researchers planning and running DCTs. The guidance covers all trial stages, from design to reporting:

• Trial design – for example, identifying groups that may be disadvantaged or excluded by the implementation of DCTs; creating tailored recruitment and retention plans for the target patients, including considering using a variety of electronic methods to match their preferences; ensuring key stakeholders are involved in trial design; considering remote delivery of therapies and sample collection
• Trial support – providing lay-friendly training and support for patients, training for trial delivery staff, and considering participant needs and preferences for communications
• Trial reporting - reporting experiences of the impact of decentralisation on data collection, quality, and equity

Dr Lee Aiyegbusi, lead author of the study, co-lead of the NIHR Birmingham BRC Patient-reported Outcomes research theme, and Associate Professor at the University of Birmingham’s Department of Applied Health Science, said: “Our research underscores the importance of integrating the perspectives of all patients into decentralised clinical trials to enhance their relevance and impact. By prioritising equity, diversity, and inclusion, we can ensure that all patient voices are heard and valued.”