Clinical Researcher: How Sponsors Can Meet Diversity Regulations

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June 20, 2023, 5:55 PM EDT

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Clinical trial participation amongst minority groups in the U.S. is woefully inadequate a challenge that has plagued this industry for years. In December 2022, substantive diversity, equity, and inclusion (DEI) legislation was signed into U.S. law and went into effect in February 2023 to help correct the significant disparity and hold sponsors responsible for ensuring that their trials represent diverse patient participant populations.

No one doubts the inherent value of broader representation in clinical trials; however, sites are burdened with delivering DEI enrollment requirements. Without an effective strategy, such regulation might impact the ability to carry out any research at all, according to conversations with industry research professionals.

"Everyone realizes the benefits of representative populations as participants in clinical trials," said a clinical operations executive at a multinational pharmaceutical company in an April 2023 interview. "Now the issue has more to do with how granular regulations might get, how it fits into overall drug development strategies, and whether it might ultimately hinder our ability to address the requirements across all regions of development while controlling for costs and ensuring scientific rigor."

While sites are responsible for participant enrollment, now sponsors must actively provide diversity guidance and support during protocol design and study start-up. Sponsors will need a reliable mechanism to ensure a diverse representation of participants in their trials or risk derailment.

Supporting Sites with Data Analytics

One way to mitigate potential impacts is for sponsors to enable their site partners with systematic data analytics. Sponsors and contract research organizations (CROs) need to manage ever- growing volumes of data in real time to ensure that trials meet planned timelines while addressing the diversity plans they have submitted to the U.S. Food and Drug Administration (FDA). Yet managing such data is difficult across all stakeholders, particularly given the rapidly expanding and disparate array of trial data sources out there.

According to a 2021 study by Tufts University, Phase III clinical trials generated an average of 3.6 million datapoints, or three times the amount of data collected by late-stage trials in 2011. Lokavant's internal analysis suggests that by 2030 these clinical trial datasets will skyrocket to seven times that of 2011.

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