The success of a clinical trial often depends on attracting the appropriate participants so that the sample reflects the general population. But how to ensure that this is the case? We?ve found some of the major problems with clinical trial diversity and how to solve them.
Who is Represented?
Studies indicate that many trials under-represent women, people of colour, and people over the age of 65.1 This is a huge problem because adverse side effects in minority groups could go unidentified.
But why is there a disparity in clinical trial diversity? One study indicated 5 major reasons for gaps in participant diversity:
Mistrust in the study including lack of understanding of the study?s value and fear of participating or communicating with researchers.
Lack of Comfort in participating because of fear of family members? opinions or mistrust of the process.
Lack of Information
Time and Resource Constraints including the financial burden and time commitment involved such as transportation availability. This is a particular concern for someone living in urban areas or senior citizens.
Lack of Awareness including the existence of the trial.2
Increasing Clinical Trial Diversity
We identified some tips to consider when designing your clinical trial to increase diversity:
Communication is key to ensuring the comfort of your participants. The form and timeliness of interaction can affect responses and willingness to join or remain in the study. It is important to establish the communication that is most appropriate and useful for your participants, whether it be face-to-face interaction, a jargon-free pamphlet, or digital communication like email or text.2 Communication should be consistent to keep patients content and answer their questions. The packaging and labeling of your products can also contribute to the effectiveness of your overall communication.
Flexibility can be a determining factor for whether a participant joins the study. Providing flexible transportation or compensation options may increase likelihood of participation.2 For example, offering alternate operation hours could allow for busy working moms to attend, and creating transportation options can increase senior participation.3 Your distribution logistics can be crucial to this flexibility.
Involve Physicians by making them aware of the trial and provide the necessary communications to inform their patients. Physicians can be a fantastic resource for recruitment and they maintain a more personal relationship with patients, making them more comfortable being involved in a study.2
Diversity is so important to any clinical study and a fair sample of the population ensures that research is fully representative. Bay Area Research Logistics can boost your ability to manage a diverse clinical trial with our planning, packaging, labeling, and distribution services. Contact us today to learn more!
What other strategies do you think could create more clinical trial diversity? Leave us a comment, we?d love to hear your thoughts!
1 Fox-Rawlings, Stephanie R., Laura B. Gottschalk, Laur?n A. Doamekpor, and Diana M. Zuckerman. ?Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?? The Milbank Quarterly 96, no. 3 (2018): 499?529. https://doi.org/10.1111/1468-0009.12344.
2 Clark, Luther T., Laurence Watkins, Ileana L. Pi?a, Mary Elmer, Ola Akinboboye, Millicent Gorham, Brenda Jamerson, et al. ?Increasing Diversity in Clinical Trials: Overcoming Critical Barriers.? Current Problems in Cardiology 44, no. 5 (2019): 148?72. https://doi.org/10.1016/j.cpcardiol.2018.11.002.
3 Taylor, Nick. ?Tools for Doctors Key to Increasing Clinical Trial Diversity, Say Experts.? Outsourcing-Pharma.com. William Reed Business Media Ltd., January 6, 2020. https://www.outsourcing-pharma.com/Article/2020/01/06/Tools-for-doctors-key-to-increasing-clinical-trial-diversity.
Further Reading and Studies: