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The Role of a Modern Data Infrastructure in Patient Diversity and Inclusion
from Supporting Diversity and Inclusion Goals for Clinical Trials with an Effective Analytics Strategy
Today more than ever, clinical development is a data-driven industry. As clinical trials become increasingly decentralized and complex, many life sciences organizations are struggling to scale sufficiently to handle the volume and variety of data that continues to proliferate. Instead of trying to adapt, patch, or modify legacy systems to account for modern-day challenges, organizations must develop an innovative data infrastructure and ecosystem that simplifies the process of organizing and managing diverse data streams.
The need for comprehensive data analysis has become even more pressing since the Diverse and Equitable Participation in Trials (DEPICT) Act was passed in February 2022. The DEPICT Act seeks to boost diversity in clinical trials by requiring enhanced data reporting on clinical trial demographics, and requires clinical trial managers to provide resources that improve access to clinical trials. The recently passed legislation states that:
■ Investigational New Drug (IND) and Investigational Device Exemption (IDE) applicants must report clinical trial enrollment targets by subgroups such as race, ethnicity, and sex and provide the rationale for those targets. ■ The FDA will have the authority to mandate post-marketing studies when sponsors do not meet diversity enrollment targets without good reason. ■ The FDA will publish an annual report aggregating and analyzing data provided by sponsors on progress towards goals for increasing diversity in clinical trials.
Further important DEPICT clarifications are:
How sponsors should submit a “Race and Ethnicity Diversity Plan” with applications proposing clinical research, or continuing with trials to support the approval of drugs, biologics, and medical devices. Sponsors must set enrollment goals for a full range of populations in order to obtain relevant pharmacological and genomic data that can help design larger studies appropriately. AND importantly have patient retention strategies, which may involve collaboration with community health workers and patient advocates and reimbursement for expenses to participants in need.
To fulfill these goals, access to near real-time data and analytics is more crucial than ever to ensure you are delivering to your plan.
Sponsors must develop and disseminate actionable and scalable solutions to promote the goal of diversity in enrollment, and to facilitate subgroup analysis in clinical trials.
