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May 16, 2022

Why is patient diversity in clinical trials important?

Expanded diversity will benefit more patients in more communities. Insights management can help get us there.
diversity in clinical trials

Clinical trials show us how medicines, medical devices, and complementary treatments work in people. The challenge, however, is that clinical trials don’t include nearly enough different people. In the US, racial and ethnic minorities are dramatically and persistently under-represented. In 2020, 75% of the over 30,000 clinical trial participants, in the trials of 53 new drugs approved that year by the FDA, were white.

Considering the preponderance of some chronic diseases in minority groups and ethnic populations — as well as different responses to treatment in diverse populations — these numbers are unsustainable, and to some extent, inexcusable. Race and ethnic background, age, gender, genetics, comorbidities, organ dysfunction, weight, and even patients’ geographic location can all play a role in determining a treatment’s safety and effectiveness.

For example, African Americans make up 20% of the people living with myeloma in the U.S. Yet they only account for 6% of all patients in clinical trials. African Americans receive 12.5% of pancreatic cancer diagnoses, yet only represent 8% of participants in pancreatic cancer clinical trials. Six percent of trial participants were classified as Hispanic — and they make up 8.5% of US cases.

A lack of diversity in clinical trials prevents the full picture of a drug’s efficacy from coming into focus. Without diversity in the trial experience, health care solutions for the range of populations will be tough to achieve.

Why is there a lack of diversity in clinical trials?

The challenges facing medical research teams in working toward a more diverse clinical trial design include:

  • Logistical and financial barriers for many patients in underrepresented populations
  • Lack of engagement with minority communities (where there may be mistrust of or hesitation of being involved with the healthcare system); too few minority clinical investigators who are easier for participants to relate to and trust
  • Language and cultural barriers
  • Trials are repeatedly being held in the same general locations — around large hospitals, academic centers, and professional for-profit clinical trial units — which are often too far for some patients to travel

How do we increase diversity participation in clinical trials?

Overhauling patient recruitment in clinical trials is one way to increase diversity. More patient participation from diverse communities will translate into more complete data to serve a wider patient base. Sponsors and clinical research teams can only develop better treatments equally effective for the entire patient population with proper representation of each subgroup of patients. The FDA recently delivered guidelines on enhancing diversity in the clinical trial population. The focus of the guidelines includes:

  • Relaxing restrictive eligibility criteria
  • Making trial circumstances less burdensome (expanding clinical study location sites, reducing the number of visits needed, using the latest health technology communication tools to enable virtual clinical trials, offering compensation for participation)
  • Providing resources in multiple languages
  • Working more closely with community patient advocates early in the development process to better understand the needs of diverse patient communities

How can insights management technology help?

With travel and accessibility among the barriers to clinical trial diversity, technology can be key to increasing access. Although one-off virtual meetings like those used in business or in telehealth applications may be problematic in clinical trial settings – due to the limitations of many patients’ time, accessibility to central clinical trial sites to participate in virtual events, and their own lack of technology – other types of virtual tools can be used to increase patient engagement in clinical trials.

A complete insights management platform provides the means to unify many trial-related activities in a single system. For example, network analytics within an insights management solution can give trial sponsors a more complete picture of targeted disease communities and influential experts. Social listening technology provides a glimpse into conversations around health conditions, treatments, and other issues. Finally, asynchronous virtual engagement can connect patients and researchers to enable better trial design and identify risks to enrollment and participation. Pharmaceutical teams report that people in virtual environments have a more equitable platform for forthright communication – a natural way to work toward more inclusive clinical trials.

Ready to dive deeper? Read our e-book and answer five questions to determine if your organization or clinical team is ready to implement insights management technology and reap the rewards of a more effective flow of information.



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