Clinical trials need to be more diverse according to the Digital Medicine Society, which hopes a new set of tools can help sponsors and CROs recruit a broader range of participants.
The Digital Medicine Society – an organization that represents the digital medicine space whose members includes Janssen, Takeda and Lilly – rolled out the digital tools this week citing a recent report that highlighted the lack of diversity in studies.
According to the study, which was based on the analysis of clinical trials between 2015 and 2019, nearly 80 percent of participants are white, while only 45 percent are women.
The Digital Medicine Society also referenced recent US FDA calls for greater diversity in drug research as a motivation for development of the toolset.
CEO Jennifer Goldsack said "it's been one year since the FDA issued draft guidance for DEI in clinical trials, and while organizations have hired DEI heads, many lack a team, sufficient budget, and clear direction to make a real difference.
“The digital tools available to us today can position us to stop admiring the problem of non-representative clinical trials and actually address the problem. To really move the needle, we need to stop making excuses and these new resources help us do just that."
Resources included in the toolkit are designed to remove obstacles to assessing, identifying, and implementing digital tools to advance diversity, equity, and inclusion (DEI) in trial design and conduct.
For example, the authors suggest definitions for terms like "diversity," "equity," and "inclusion" as well as details to guide each step of a digitized clinical trial.
The toolkit also features an interactive timeline that tells clinical research organizations (CROs) and sponsors which digital tools they can use during each stage of a digitized clinical trial, DEI opportunities and risks to consider, and real-life examples of tool usage.
The DEI also provides recommendations on how to use digital tools to improve and increase enrolment and retention of diverse participants in digitized clinical trials.