Enabling Patient Centricity by Improving Diversity in Clinical Development

Date: 09. 21. 2022

A few weeks ago, our founder and CEO, Dr Gen Li, was invited for an interview with Alivia Kaylor from Xtelligent Healthcare Media, to discuss our data around diversity in clinical trials. The conversation raised some interesting questions about diversity and decentralization in clinical trials. We’ve been reflecting on the issues raised in the discussion, and the strategies the clinical development industry can take to ensure patients who are enrolled in trials are representative of the patients who will receive the drug in the real-world. This is particularly important as new Draft Guidance for Industry from the FDA will demand more action in this area from trial sponsors.

In the US, one of the main factors contributing to the lack of diversity is inequitable access to healthcare, particularly for Black and Latino communities. Additionally, and as Alivia highlighted in the discussion, according to data from the Association of American Medical Colleges, 55% of medical school graduates from 2018-2019 were White, whereas only 22% were Asian, and only 6% were Black or African American.

These disparities are stark, and there is no doubt that they are contributing to the failures of diversity that we are seeing in patient groups in clinical trials. Patients want to feel represented, and they want to visit doctors that look like them in locations that are convenient to them. When recent medical graduates enter society and build their patient base to refer to trials, they often lack patient diversity, which adds another layer of complexity to the problem. Encouraging intakes of medical graduates that properly represent the population in the US is one way of addressing this.

One other way to improve diversity in clinical trials is by taking a data-driven approach. Sponsors can use the data available to them to identify appropriate recruitment sites and select patients that better represent the target population. With insights from data, the industry has the potential to ensure cohorts enrolled in clinical trials are more representative of the patients who will receive the drug. This will enable us to develop safer, more effective treatments for all.

One of the use cases that Phesi’s integrated offering delivers is to help our clients tackle challenges around diversity. We help clients achieve this aim by harnessing the power of real-time data. By reviewing trial, research and patient data – including protocol designs and amendments – Phesi helps sponsors understand patient characteristics for any indication in depth, to ensure trials are patient-centric and protocols are inclusive. Our goal is to help sponsors develop smarter trials that result in faster cures, for everyone.

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