Regulatory demands for greater diversity are likely to change drug development and prompt industry to rethink protocol design according to new analysis.
The study – published in the current addition of clinical cancer research – looked at the likely impact recent diversity initiatives – including recent draft guidelines released by the US Food and Drug Administration (FDA) – will have on the drug industry’s approach to trials.
And the impact has been significant according to the authors, who write that such measures represent a “profound change to the drug development process.” They predict significant change to the clinical research ecosystem will be “needed to undo decades-long disparities in clinical trial participation rates among racial and ethnic minorities.”
They cite staff training as an area in which sponsors, CROs and trial sites will need to invest to meet diversity goals, suggesting drug studies will need to be run by “culturally competent clinical trial staff.”
The financial infrastructure surrounding trials will also need to evolve according to the researchers.
“Defining which financial supports are allowable for patient study-related costs through legislation and regulation would provide needed clarity for trial sponsors to address common barriers to participation.”
Regulators’ demands for diversity are also likely to accelerate alignment of trial regulations according to the authors, who predict knowledge sharing will increase.
“Harmonization of international regulations and development of frameworks to facilitate the design and conduct of diverse global clinical trials would decrease the burden of implementing comprehensive diversity, equity, and inclusion (DEI) initiatives.
“Effective change management practices, including the analysis of ongoing efforts, and non-competitive sharing of ideas will be essential for identifying successful strategies to improve DEI in clinical research, including in clinical trials.”
Cancer trial diversity
The good news is that the trials industry is already responding according to the authors, who cite the oncology sector as an example.
“Many in the oncology research community have begun implementing strategies to facilitate culture shift from a retrospective view of DEI to one that is prospective and integrated into comprehensive development plans.
“However, meaningful, sustainable change will require long-term dedicated efforts from sponsors of all sizes, academic researchers, patient advocates, and federal agencies.”
They point to the US National Cancer Institute’s Cancer Therapy Evaluation Program and Community Oncology Research Program as examples of how a diversity enhancement infrastructure could be developed.
“They have well-established track records of supporting clinical trial infrastructure and staff across the United States, including at non-traditional community sites; building on this experience could provide a roadmap for additional investments.”