Enhancing diversity in clinical trials remains a crucial objective within the pharmaceutical industry and regulatory landscape, aiming to promote health equity. Despite concerted efforts, progress in this realm has been sluggish, prompting recent legislative actions and regulatory initiatives to address the issue.
The mandate for diversity in clinical trials, as stipulated in the 2022 omnibus spending bill, has emerged as a pivotal step in addressing disparities within medical research. This legislative action has significantly elevated the discourse surrounding diversity and inclusion in clinical trials, underscoring the importance of representative participant demographics. In response to this mandate, the US Food and Drug Administration (FDA) assumed a proactive role by initiating the drafting of comprehensive guidance aimed at ensuring industry sponsors prioritize diversity in their trial enrollment practices.
The FDA’s draft guidance seeks to establish clear expectations for industry stakeholders regarding the development and submission of diversity plans. These plans are intended to delineate specific enrollment goals for underrepresented racial and ethnic groups in pivotal drug trials. By mandating the inclusion of such diversity plans, the FDA aims to foster greater inclusivity in clinical research and mitigate the longstanding issue of underrepresentation among certain demographic groups.
Despite the legislative mandate and the FDA’s proactive stance, the release of additional guidance has encountered delays. While the 2022 omnibus spending bill stipulated a deadline for the FDA to provide further guidance by the end of 2023, as of the present, such guidance has not materialized. This delay has prompted inquiries and calls for action from lawmakers and advocacy groups, highlighting the urgency of addressing this critical issue.
The Critical Push for Diversity in Clinical Trials Amid Pharma’s Proactive Measures
The absence of updated guidance has led to uncertainty within the pharmaceutical industry and among regulatory stakeholders regarding the specific requirements and timelines for compliance. Moreover, it has raised concerns about potential delays in implementing measures to enhance diversity in clinical trials effectively. Recognizing the significance of this issue, stakeholders across the healthcare ecosystem are urging the FDA to expedite the release of comprehensive guidance to provide clarity and direction to industry sponsors.
In the interim, stakeholders continue to emphasize the importance of prioritizing diversity and inclusion efforts in clinical research. Addressing the underrepresentation of certain demographic groups in clinical trials is essential for ensuring the generalizability and validity of research findings, as well as promoting health equity. As such, there is a collective call for concerted action and collaboration among regulatory authorities, industry sponsors, healthcare providers, and advocacy organizations to advance the cause of diversity in clinical trials and improve the overall quality and impact of medical research.
In parallel, major pharmaceutical companies have implemented their strategies to address trial diversity. Takeda Pharmaceuticals, a prominent Japanese drugmaker, has set ambitious objectives to achieve “unprecedented patient diversity” in phase 3 trials for its pivotal psoriasis candidate, TAK-279. Karen Correa, Vice President and Head of Global Clinical Operations at Takeda, highlighted the company’s commitment to enrolling participants in phase 3 trials that mirror real-world data and the broader patient population.
Takeda Champions Diversity in Clinical Trials for Psoriasis Treatment TAK-279, Setting a New Industry Standard
Takeda’s interest in diversifying its trials stems from its acquisition of TAK-279 from Nimbus Therapeutics, a deal valued at $4 billion. TAK-279, an investigational oral allosteric tyrosine kinase 2 (TYK2) inhibitor, demonstrated promising results in phase 2b studies for treating plaque psoriasis and psoriatic arthritis. Positioned as a potential competitor to Bristol Myers Squibb’s psoriasis drug Sotyktu, TAK-279 holds substantial market potential.
The phase 3 trial designs for TAK-279 incorporate diversity action plans, aligning with the FDA’s initial guidance. Since June 2022, Takeda has integrated diversity action plans into all new clinical trials, underscoring its commitment to inclusivity and accountability.
Karen Correa emphasized that Takeda does not view regulatory mandates as pressure but rather as an impetus to uphold ethical standards and foster diversity in clinical research. This proactive approach reflects Takeda’s dedication to advancing health equity and ensuring that clinical trials are representative of diverse patient populations.
Resource: Pharmavoice, March 27, 2024
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
