Health literacy and diversity in clinical trials

Posted in October 2022

October is health literacy awareness month. Health literacy is about people having enough knowledge, understanding, skills and confidence to understand health information and navigate health and social care systems. It is incredibly important to pharmaceutical development and the successful launch of new therapies. That is why Branding Science Vice President Tom Donnelly and Associate Director Portia Gordon are involved in the Intellus Clear Healthcare Communications Taskforce as Chair and member respectively.

To understand more about health literacy and its impact on pharmaceutical development, Tom and Portia recently took part in the taskforce’s work to improve participation among racial and ethnic groups in clinical trials by leveraging health literacy principals. Existing research has shown that reasons for reluctance may include:

  • Mistrust of the clinical research system due to historical abuses
  • Aspects of the trial design such as inadequate recruitment and retention efforts
  • Frequency of study visits
  • Time and resource constraints for participants
  • Transportation and participation conflicting with caregiver or family responsibilities

The problem is so great that the U.S. Food and Drug Administration (FDA) noted in their 2022 Diversity Guidelines that “in addition, language and cultural differences, health literacy, religion, limited access within the health care system and a lack of awareness and knowledge about what a clinical trial is and what it means to participate may impact clinical trial participation among racial and ethnic minority populations.”

Tom, Portia and the team focused on communication clarity during trial recruitment, with a view to analyzing rates and reasons for diverse groups refraining from participating in clinical trials. They conducted a 2-phase project. First, they conducted qualitative research using in-depth phone interviews with qualifying individuals on topics regarding trust in the healthcare system, awareness of clinical trials, and reluctance towards participation. Next, they conducted quantitative research using an online survey with members of the Black, Indigenous and People of Color population, covering reasons to participate or not to participate in clinical trials. A few of the key insights included:

  • Only 23% have confidence that they are fully aware of a clinical trial’s meaning, process, etc.
  • Participants show higher rates of approval towards statements that are in favor of clinical trials and prove its benefits.
  • Respondents felt they would not participate specifically because race was in the summary and that is a cause for concern to many.

This research indicated that clinical trial recruitment materials need to be carefully worded and focused. Clinical trial organisers and pharmaceutical companies more generally need to recognize that clinical trials are viewed as useful but not without risk. Those that are designed to reach specific ethnic groups raised suspicion and were perceived as riskier and less attractive. Those who have participated in clinical trials previously or know anyone who has, are more likely to participate in future. Higher awareness leads to higher participation and that organisers need to find a way to overcome low awareness and understanding around clinical trials whilst also minimising the perceived risk to the individual taking part.