Adapting to Policy Shifts: Why Diversity in Clinical Trials Still Matters

Recent policy shifts within the federal government have caused uncertainty. These rapid changes reflect the evolving nature of government regulations aimed at improving efficiency. However, at KLEO, we want to emphasize one constant amid these fluctuations—our commitment to diversity in clinical trials.

On January 29, 2025, the U.S. Office of Management and Budget (OMB) rescinded M-25-13, a memorandum issued just two days earlier that required federal agencies to temporarily pause all activities related to the obligation or disbursement of all Federal financial assistance that may be implicated by recent executive orders. The release of M-25-13 cause confusion and impacted many in our field, including clinical trial sponsors and healthcare organizations relying on federal contracts.

M-25-13 faced immediate legal challenges, and in the days after its issuance, a federal judge issued an administrative stay on portions of the memorandum before the memo was officially rescinded by the OMB. Despite the rescission, however, the White House press secretary clarified that the funding "freeze" was still in place, stating that the rescission applied only to the OMB memorandum, not to the broader implementation of the President’s executive orders.

The freeze, according to OMB, is intended to ensure that federal financial assistance is aligned with the Administration's priorities, particularly in areas such as immigration, foreign aid, environmental and energy policy, and diversity, equity, and inclusion (DEI) programs.

In clinical research, ensuring that study participants reflect the diversity of our broader population is critical. This commitment to inclusiveness ensures that new medical products and treatments are effective across all demographics, considering variations in race, ethnicity, age, and gender. At KLEO, we believe that diverse trial participation strengthens the scientific validity of clinical data and makes healthcare innovations accessible, relevant, and safe to broader populations.

As we continue to work alongside innovators to bring medical products to market, we will always advocate for strategies that place an emphasis on reaching underrepresented groups. Despite regulatory changes and uncertainty, our core values remain unchanged. We will continue to prioritize diversity in our clinical trial strategies, ensuring that healthcare innovations can improve the lives of everyone.

At KLEO, we're not just moving with the tide of policy changes—we’re committed to ensuring inclusivity in clinical trials to build a healthier future for all.