From the Executive Director

Dear CSDD Friends,

For stakeholders throughout the clinical research enterprise, words and terminology matter. We deliberate over the definition of concepts and variables and how they are measured.  But more than words, as an enterprise we commit to the intent behind them to advance scientific and operating excellence.  Today there is wide agreement, for example, that the term ‘Decentralized Clinical Trials’ is a misnomer though its intent and promise is widely embraced.  The term places remote and virtual technology solutions in relation to the investigative site when a major impetus for their deployment is to offer access and convenience to the patients at the heart of all clinical trial activity. 

Last month, in private and public conversations and meetings, we witnessed another case where terminology and intent were unexpectedly at odds:  Although the words ‘Diversity’ and ‘Inclusion’ — long established principles guiding strategies and practices in drug development — have fallen out of favor, it is our unrelenting intent and commitment to ensure access and proportional representation in our clinical trials that matters most.

Tufts CSDD projects play a key role in measuring how intent and commitment — strategies, practices, solutions and regulatory reforms — are impacting performance, quality and economic outcomes. We publish the results of our research extensively to share learnings and insights.  We have a rich pipeline of projects presently: we are assessing the transition of high frequency, legacy monitoring to centralized monitoring; measuring patient and site participant burden in clinical trials;  looking at centralized recruitment strategies and their impact on enrollment performance; quantifying the value proposition of risk-based quality management; evaluating practices that influence vaccine confidence; and — in collaboration with TransCelerate — identifying actionable opportunities to optimize clinical data volume. 

We recently launched a new study looking at participant compensation strategies and their impact on enrollment effectiveness.  And later this year we will be constituting our next protocol design and complexity benchmarking study.   Please refer to the Tufts CSDD website or reach out to me directly (Kenneth.getz@tufts.edu) to learn more about and to participate in any of the Center’s projects. 

Lastly, I want to acknowledge and thank our faculty, students and the Tufts CSDD admin team for an outstanding Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation. Through word-of-mouth, we already have registrations for next year’s program.  Please refer to our website or contact the Tufts CSDD team (Sarah.wrobel@tufts.edu and Ava.Feuer@tufts.edu) for more information about any of our professional development offerings including customized onsite and virtual programs.

As always, we welcome your collaboration and support. 

Kenneth Getz

Executive Director, Tufts CSDD

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

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