OCT East 2023: Achieving Global DEIA in Clinical Trials


Harsha K. Rajasimha, PhD, founder and executive chairman, IndoUSrare, provides the OCT audience insights into better achieving DEIA clinical trials.

In a presentation at Outsourcing in Clinical Trials East Coast 2023, Harsha K. Rajasimha, PhD, founder and executive chairman, IndoUSrare, and former guest of the Applied Clinical Trials Podcast, discussed what industry must do to achieve diversity, equity, inclusion, and access (DEIA) in clinical trials.

To begin, Rajasimha pointed out that the access portion has “gone missing.” Of the major considerations typically taken into account in clinical trials: patient recruitment and retention, managing protocol complexity and amendments, vendor management, and manual repetitive tasks and errors; all of which are overshadowed by cost, diversity is often left out.

Harsha Rajasimha, MS, PhD Founder and Chairman, IndoUSrare | Image Credit: © author

Harsha Rajasimha, MS, PhD, Founder and Chairman, IndoUSrare

What are the largest barriers to achieving DEIA in clinical trials? Geographic location is a major pain point, which is nothing new to industry. There often isn’t alignment on complex cultural barriers such as language, religious beliefs, and dietary restrictions. A lack of data for all diversity parameters, especially in rare diseases, as well as mistrust among diverse populations are also major barriers.

Rajasimha addressed that one of, if not the largest issue within mistrust among diverse populations is that they are less frequently asked to participate in trials.

How can these paint points be addressed to work towards achieving DEIA in trials? It starts with regulatory policies, mandates, and guidelines. There also must be a commitment among all stakeholders with a shared goal. This includes global thinking and cross-border collaboration as well as more inclusive digital and data platforms. An overarching solution is implementing next generation training and education programs for cultural competency for clinical trial stakeholders.

While the COVID-19 pandemic disrupted many aspects of the clinical trials industry, it has provided the opportunity for stakeholders to reflect on pain points such as diversity. Rajasimha concluded by noting that industry has never been so open to new ideas and technology. The time to make clinical trials more accessible is now.

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