In the wake of COVID-19, decentralised trials—remote research facilitated by digital tools—have become increasingly prominent. They have the potential to vastly increase access and participation, but not necessarily for everyone. The University of Birmingham leads the way with new recommendations for equality, diversity, and inclusion (EDI) in decentralised trials.

Researchers from the Centre for Patient Reported Outcomes Research (CPROR), the NIHR Birmingham Biomedical Research Centre (BRC) and the Applied Research Collaboration West Midlands at the University of Birmingham have addressed the barriers to inclusive participation in decentralised clinical trials (DCTs). An interdisciplinary approach involving academics, trialists, public contributors, and industry experts has developed a set of recommendations to combat these barriers.

These guidelines for sponsors and trial teams aim to ensure that DCTs are designed, delivered, and reported in ways that promote inclusivity. By following these suggestions, DCTs could be much more accessible and involve more underserved groups from design to completion.

Decentralised trials present an excellent opportunity for inclusivity, but also introduce new barriers, including digital literacy and access to reliable internet. For instance, many patients may need access to a mobile phone or the technical knowledge to use digital tools. Furthermore, particularly among the elderly or people with disabilities, technical knowledge may be limited due to lack of experience, hindering participation. Cognitive and physical limitations often also affect engagement from these groups, exacerbating health disparities and overall undermining the purpose of DCTs.

Decentralised trials present an excellent opportunity for inclusivity

To help promote equitable participation, the guidance stresses the importance of designing trials that specifically address the needs of marginalised communities. Targeted recruitment strategies which more carefully consider challenges faced by certain groups, and involving diverse stakeholders is an important step to ensuring EDI in these trials. Including patients from underserved communities in the design process could ensure maximum responsiveness within trials.

Providing extensive support for participants throughout the trial process is another key element of the guidance. Ensuring that patients and trial staff alike have access to lay-friendly training materials which are clear and accessible is a vital way of promoting diversity. Special consideration should be taken regarding varied learning styles – ensuring translations, visual aids and demonstrations are all included can promote confidence with digital tools.

Ensuring translations, visual aids and demonstrations are all included can promote confidence with digital tools.

The guidance also suggests offering flexible communication based on the preference of the participants. This could range from video calls to text messages, to ensure participants feel as supported and confident as possible. Remote delivery of interventions, such as therapy or sample collection, can also help alleviate logistical barriers like travel, making trials more accessible for patients who may otherwise be excluded.

The importance of transparency in trial reporting was the final area of focus of the guidelines. This encompasses both scientific outcomes and an analysis of how data quality may have been affected by digital barriers. Researchers are encouraged to track participant diversity and report on the effectiveness of strategies aimed at reducing disparities. Disaggregating data by factors such as disability, race and gender confirms data collection or design of the trial has not disadvantaged any group.

Dr. Lee Aiyegbusi, the lead author of the study and Associate Professor at the University of Birmingham’s Department of Applied Health Science, highlighted the importance of considering the perspectives of all patients when designing decentralized clinical trials. He noted ‘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.’

‘By prioritising equity, diversity, and inclusion, we can ensure that all patient voices are heard and valued.’

Focusing on equity, diversity, and inclusion is vital to ensure that trials are scientifically accurate, responsible and relevant to diverse communities. By extending research to as many people as possible, it will allow a significantly greater, and more impactful understanding. For DCTs to be the most effective, they need to be accessible to everyone.

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