From the Executive Director

Dear CSDD Friends:

In September and October, Tufts CSDD will be launching a record number of working group studies. We will soon be kicking off a new study mapping and quantifying the effectiveness of centralized recruitment methods.  Another study launching in September will assess the rapidly evolving global investigative site landscape and develop a new segmentation that will recognize emerging clinical trial execution models including site staff embedded within clinical care settings, remote sites (e.g., specialty labs, retail pharmacies, urgent care facilities), mobile sites and home health services.

In early October, Tufts CSDD will be launching a working group study looking at how sponsor companies are making the transition from legacy high-frequency study monitoring to risk-based monitoring approaches in part in response to ICH E6 R3 and ICH E8 R1 guidelines. And a second study will look to quantify the magnitude of the ‘last mile’ problem in clinical research where prospective patients who inquire about a clinical trial or respond to an outreach campaign are lost, having elicited no response from site personnel or having received outdated and inaccurate clinical trial information.

All of our working group studies offer a unique opportunity for sponsors and CROs to participate in collaborative research initiatives focusing on timely, impactful, and actionable issues. Participating companies help shape the study hypotheses and methodology, review, and interpret study findings and their implications. Throughout the project, working group participants benefit by sharing experiences and insights. Please contact me at Kenneth.getz@tufts.edu if your organization is interested in participating in any of our upcoming working group studies.

We look forward to seeing many of you at upcoming conferences this fall. The CSDD team will be presenting the results of several recently, and soon-to-be-completed studies including research on assessing study volunteer participation burden and its impact on clinical trial performance; The adoption of RBQM and the associated implementation challenges; new strategies for improving diversity and representation in clinical trials; trends and practices in the vendor qualification process and the time and resource investment required by contract service providers responding to the qualification process.

We will soon be accepting registrations for our award-winning Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation. This highly interactive program will be offered virtually during the month of February. More information is available on our website (csdd.tufts.edu)

As always, we welcome your ideas, input, and collaboration. Wishing you the very best,

Kenneth Getz

Executive Director, Tufts CSDD

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

DiMasi JA, Dirks A, Smith Z, et al. Assessing the Net Financial Benefits of Employing Digital Endpoints in Clinical Trials.  Clin Transl Sci. July 28, 2024.  Access article.

Florez, M. I., Botto, E., & Kim, J. Y. (2024). Mapping Strategies for Reaching Socioeconomically Disadvantaged Populations in Clinical Trials. JAMA Network Open. June 7, 2024. Access Article.

Getz K. How Much Does a Day of Delay in Clinical Trials Really Cost? Applied Clinical Trials. June 6, 2024; Volume 33, Issue 6. Access Article.

To access a comprehensive list of published Tufts CSDD manuscripts and articles, visit Articles - Tufts CSDD