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The Importance of Achieving Diversity in Rare Disease Clinical Trials

Increasing diversity and inclusion in clinical trials has become a subject of heightened focus – and understandably so. Including a more diverse patient population in trials ultimately results in confidence that a product will be able to address the needs of more people. Factor in the unique challenges of the rare disease population, and the urgency to increase diversity becomes even more important, as genetics play such a critical role in understanding rare diseases – and, subsequently, finding treatments and cures. As trials inherently have strict patient eligibility criteria, trial designers need to be more proactive in identifying a diverse and inclusive population of subjects that meet those disease state criteria.

Historically, diversity in clinical research has focused first and foremost on ethnic diversity when there are many facets of diversity. Further, when considering inclusion, there are other factors to consider, such as physical abilities and the limitations they present to participate in clinical trials.

Achieving genetic diversity in rare disease trials means considering all angles of diversity and inclusion – and then taking action to make it a reality. For example:

  • Using telemedicine: This approach provides options for families of patients with rare diseases who may not be able to access clinical trials or genetic services because of geographic barriers. The ultimate goal, especially when considering patient-centric trials, is to be sure not to add to the burden and lack of access to clinical trials. Telemedicine can bridge that challenge and make trials possible.
  • Engaging community physicians: Especially in rare disease studies, there may be a very small handful of sites across the nation – and how many patients will have ready access to those sites, especially if the site is at an academic medical center, for example? Engaging a patient’s own physician to identify eligible patients, when possible, or using local access points or virtual outreach can broaden the possibility of including a diverse population.
  • Simplifying solutions: Providers face challenges when thinking about incorporating genetic testing or clinical trial screening into their practice such as lack of training and uncertainty on how to interpret test results. Further, it takes significant time to interpret the results of testing and sit down with patients and families and really help them to understand the results of those tests, especially given how increasingly complex tests are becoming. Partnering with an organization such as InformedDNA to help interpret results can help streamline the process, increasing the likelihood of a patient really understanding their eligibility and options.
  • Including interpreters in the process: To ensure that patients who do not speak English are not excluded from research, it’s important to ensure access to medical interpreters for every language. That way, every patient, regardless of the language they speak, has the ability to participate in research and understand everything from enrollment through test result interpretation.
  • Providing personalized support: Having patient care coordinators who can liaise directly with patients cannot only help the patient feel supported but increase the likelihood they will stay in the trial through completion. When the care coordinators represent diversity themselves, this can create a commonality and trust that will not only be authentic but help keep patients engaged.
Diversity in Clinical Trials

Achieving genetic diversity in clinical trials is not only critical to study success, but it organically creates patient-centric trials that put the patient at the center of research from the start by reducing physical, financial, and emotional burdens.

Get Informed

Rare disease clinical trial success depends on a well-informed team to decode many of the challenges facing clinical research. Since genetic components add many intricacies to a clinical trial, patient identification and recruitment require strategic thinking and appropriate expertise and resources to ensure the trial’s success.

Learn more about our solutions for sponsors and CROs, including InformedRECRUIT™, that help you overcome rare disease clinical trial challenges. Just submit the short form below. Or, if you’re ready to chat, email us at pharma@informeddna.com or call us at 844-846-3763.