Driving Equity in Clinical Trials with a Diversity First Mindset…….Meeting The Need.

A paradigm shift for increased diversity in clinical trials cannot be overemphasized post-covid-19 pandemic. Identifying, recruiting, and retaining study participants are critical to trial success. However, in cases of participants who are ethnically diverse, the challenges are particularly profound.

The persistent overrepresentation of white participants in clinical trials is particularly striking as consideration is not given to the heavy burden of chronic disease in minority ethnic populations.

Why Advocate for Diversity?

Why is it so important?

• Improving the effectiveness, efficiency, and safety of the new drug
• Building broad confidence across all communities and increasing public perceptions as everyone sees representative participants
• Reducing health disparities by providing access to unapproved investigational medicines and potentially lifesaving therapies when there are few or no alternatives.

If healthcare is really for everyone, then everyone deserves access to revolutionary diagnostics and therapeutics, so increasing clinical trial diversity is an ethical, medical, moral, scientific, and strategic imperative. Inclusive research equals medically and scientifically sound research and supports more informed regulatory decisions and more accurate interventions.

Motivations to Participate

Altruism is a common reason why people volunteer for clinical trials. It is an opportunity to contribute to the common good or help others who have or may develop similar health issues, allowing the person to help grow the base of scientific knowledge. Diverse people rarely participate due to a lack of awareness and not even being asked to participate.

Best Practices for Improving Patient Diversity

1, Building Better Communication and Trust: Rebuild faith in clinical trials within underrepresented communities by speaking to historical errors and recognizing the root cause of health disparities is essential to bridging the gap. CROs and sponsors should make it clear at inception that the goal is to advance community health. Without clinical trials, the development of new medicines to improve the human condition would not be possible.

2, Building Partnerships in Regional and Local Communities: Sponsors and CROs should aim to proactively engage a network of clinical trial sites located in diverse, underserved communities. Partnerships should be scalable and sustainable, with a long-term-oriented strategy that bridges multiple indications. A consistent pipeline of trials within the communities ensures economic sustainability in the long run.

3, Diversity in Clinical Trial Staff: A diverse pool of investigators, trial coordinators, and providers would show a human face to the trials and in the long run develop the next generation of study leaders and facilitators.

4, Clear understanding of Social Determinants of Health: Clinical trials rarely report participants’ socioeconomic status, so social determinants are too often underplayed. However, access to convenient transportation, exercise/recreation facilities, and nutritious foods are significant contributors to overall health and wellness. Failing to capture potential barriers to trial participants will lead to a decrease in a group of fully representative trial participants. To address this, sponsors and CROs should place more emphasis on the social determinants of participation in clinical trials.

At Xcene Research we take pride in finding innovative global health solutions for today and the future through clinical research one way this can be achieved is through equity in clinical trials.