Best practices for advancing clinical research in the community

This blog article was written by Chris Williams, founder of Tiggo Care, a community care business supporting vulnerable adults in London.

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Introduction

Community based clinical research refers to research studies primarily conducted via general practitioners, community health centres, pharmacies, and local outpatient facilities rather than academic institutions. Study designs vary from randomised controlled trials (RCTs) to cohort and case-control studies. This blog post focuses on RCTs.

Well-designed RCTs using a community-based approach have been shown to improve access to underrepresented populations, increase diversity in study populations and accelerate enrollment. By following best practices for conducting community-based clinical research, including appropriate training and stakeholder engagement, you can ensure your trial is a success. Let's take a closer look.

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Engaging with the community

Engaging with key community stakeholders is essential to delivering a successful community-based RCT. You will need to recruit participants from hundreds or even thousands of sites. Appropriately managing these relationships can be challenging, and failing to do so can lead to poor recruitment of the right participants (i.e., those that are eligible, willing to join, and compliant). Budgeting additional team members to manage these relationships can ensure stakeholders remain engaged, recruit the right participants and encourage them to remain compliant, getting you as close to complete follow-up as possible.

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Regulatory requirements

As with all clinical trials, you must ensure your community-based RCT meets regulatory requirements and that everyone involved is appropriately trained. This can be costly and logistically challenging, especially when running a study with many sites. When designing a training program, particular focus should be given to informed consent, proper blinding of participants, participant safety, data management and reporting. Many stakeholders in a community-based trial may have never been involved in clinical research before. Therefore, you must ensure they all have the appropriate skills to remain compliant.

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Promoting research integrity

As the clinical trial manager, you must promote research integrity amongst all your stakeholders, which will help maintain participant safety and the validity of the research. Explaining randomisation and bias principles will help ensure you have valid and reliable research. It's also essential to maintain public trust in your trial. Most participants will have likely never participated in a clinical study, and it's up to you to ensure they understand the process and that everyone involved acts honestly.

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Patient-Centred Research

We've discussed the importance of training and building relationships with site managers and staff assisting with community-based clinical research. Still, it's also crucial to encourage patients' active participation and remember they're essential stakeholders in the trial. This is more commonly known as patient-centred research and involves paying particular attention to each participant's beliefs, preferences, and needs..

In community-based research, there are additional challenges when using a patient-centred approach. Diverse study populations spread over large geographic areas require clinical trial managers to balance varying beliefs and needs while trying to maintain the integrity of their study. This is why it's essential to ensure site managers fully understand the concept of research integrity because they have the best understanding of the beliefs and needs of the participants at their site. If they fully understand the study's parameters and determinants of good study design, they'll be best placed to meet the needs of the participants at their sites.

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Conclusion

In conclusion, community-based clinical research can help improve diversity and accelerate enrollment, but additional planning is required to account for the complexities of managing many hundreds or thousands of sites. Proper training for site managers and staff on research integrity and regulatory requirements can reduce the strain on trial managers. A patient-centred and appropriate engagement with the community can help ensure your trial runs well from start to finish.

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Bibliography

• Community-based clinical trials (CBCT), Nih.gov
• Katie Goodman, RN, BSN (2020) The benefits of community-based clinical trials - American oncology network, LLC, American Oncology Network, LLC
• Younossi, A. et al. (2021) Enhancing clinical trial diversity, Deloitte Insights. Deloitte
• Versavel, S. et al. (2023) “Diversity, equity, and inclusion in clinical trials: A practical guide from the perspective of a trial sponsor,” Contemporary clinical trials, 126(107092), p. 107092
• Jayadevappa, R. (2017) “Patient-centered outcomes research and patient-centered care for older adults: A perspective: A perspective,” Gerontology & geriatric medicine, 3, p. 2333721417700759
• Sharma, N. S. (2015) “Patient centric approach for clinical trials: Current trend and new opportunities,” Perspectives in clinical research, 6(3), pp. 134–138. doi: 10.4103/2229-3485.159936
• Goodlett, D. et al. (2020) “Site engagement for multi-site clinical trials,” Contemporary clinical trials communications, 19(100608), p. 100608. doi: 10.1016/j.conctc.2020.100608
• Walker, R. et al. (2014) “Research staff training in a multisite randomized clinical trial: Methods and recommendations from the Stimulant Reduction Intervention using Dosed Exercise (STRIDE) trial,” Addiction research & theory, 22(5), pp. 407–415. doi: 10.3109/16066359.2013.868446
• Bouter, L. M. (2018) “Fostering responsible research practices is a shared responsibility of multiple stakeholders,” Journal of clinical epidemiology, 96, pp. 143–146. doi: 10.1016/j.jclinepi.2017.12.016