From the Executive Director

Dear CSDD Friends:

Notable announcements and events during this past month underscore areas that are most challenging and changing drug development operating practices: In early June, a private equity group (EQT) took a majority ownership stake in CluePoints, a leading provider of risk-based quality management (RBQM) solutions. Later in the month, the unprecedented proliferation of ML/AI vendors and users was on display at the DIA Annual Meeting. On June 26, the FDA issued a draft guidance on Diversity Action Plans required of research sponsors to demonstrate their intent, rationale, and plans to achieve proportional representation in their clinical trials.

Tufts CSDD has been conducting empirical research to explain and inform many of these notable occurrences. Studies underway on the adoption of RBQM and on protocol data optimization strategies will characterize inefficiencies and opportunities to more effectively manage high and rising clinical data volume and the challenges associated with source data review and verification. Tufts CSDD — in collaboration with the Drug Information Association —has been compiling real AI/ML use cases to show where progress in drug development is being realized. Several CSDD studies are examining factors associated with the underrepresentation of select patient communities in clinical trials and gathering hard evidence on practices and solutions improving access and patient enrollment diversity. Please reach out to me if you’d like to learn about these and other studies and opportunities at Tufts CSDD.

We have also seen an unprecedented number of requests for proposals and presentations during May and June. Please contact me if you would like to discuss new study ideas or upcoming meetings and conferences where you would like Tufts CSDD to participate. Our Circle of Supporter members also meet twice each year to discuss burning issues and set research priorities. Please let me know if your organization is interested in joining these discussions.

This Insider and the CSDD website  are always great places to learn about Tufts CSDD projects, publications, and presentations. We welcome your input and collaboration.

Kenneth Getz

Executive Director, Tufts CSDD

To access hard-hitting Tufts CSDD charts and tables, visit  https://csdd.tufts.edu/impact-reports.