The Tufts CSDD Insider is the best way to stay connected with the Tufts Center for the Study of Drug Development. Published monthly to provide updates on center activity, The Insider details upcoming research studies, professional development courses, publications and presentations. The most recent issue of the Insider is available below. 
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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 On June 26, the FDA issued a draft guidance on Diversity Action Plans required of research sponsors to demonstrate their intent, rationale, and plans to achieve proportional representation in their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.

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Kenneth Getz

Executive Director, Tufts CSDD

CSDD Cost Study Graphic #1-2

Tufts CSDD offers a variety of custom on-site and virtual Drug Development Training Courses covering fundamental areas of drug development and regulatory science, and hot topics on issues, challenges, new practices, and solutions. Programs are customized to the specific needs of individual organizations. Interested in more information? Visit our website for a list of sample topics or email Sarah Wrobel


Tuft CSDD is currently collecting industry data for a research study that updates the Center’s earlier empirical work estimating the total cost of new drug and biologics development, average development time, and attrition rates by phase and therapeutic category.


Participating in the study is crucial for pharmaceutical and biotechnology companies to ensure that current, comprehensive data informs R&D strategies and regulatory discussions, especially given the historical underrepresentation of smaller and mid-size firms in past assessments. An updated, evidence-based estimate is essential for guiding policymaking and fostering innovation in biopharmaceutical development worldwide.


Please contact Dr. Joseph DiMasi — the study’s principal investigator — indicating your organization’s willingness to participate, whom from your organization will serve as the liaison and please provide the designated liaison’s contact information. You can also contact Dr. DiMasi for additional information about the Tufts CSDD survey project and how any data provided by your company would be used.

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Tufts CSDD/DIA Artificial Intelligence (AI) Study
Tufts CSDD and the Drug Information Association (DIA) are conducting a global study to understand the uses of artificial intelligence (AI) and machine learning (ML) in drug development. The goal is to capture the attitudes, perceptions, practices, and experiences of industry professionals with AI technology, and to gather information on the resources and skills required to successfully adopt it. The survey should take about 20 minutes of your time. In appreciation for your participation, you will have the option to receive a summary report of the results of this research. Your responses are anonymous and will be strictly confidential, and results will only be reported in the aggregate. If you are interested in participating, please complete the survey here.
If you have any questions, feel free to contact the research team at Thank you in advance for your participation in this important research effort!


Introducing Our July/August Impact Report
Dollar Value of One Day Delay in Drug Development is Now 20% of Blockbuster Era Levels

The July/August 2024 Impact Report (Volume 26, Number 4) is now available. The issue presents new estimates of the financial value of a day of delay in drug development. The results show a dramatic decline in the average value of a lost or delayed day of prescription drug or biological sales and present variation in financial value by disease conditions.

Learn more | Purchase online

The Tufts CSDD Impact Report keeps you up-to-date with the evolving drug development & clinical trial landscape through data-driven analyses, trends, and industry insights. Annual and multi-reader subscription rates are available. Subscribe today to stay informed.
May 2024 Chart

To access hard-hitting Tufts CSDD charts and tables, visit

Florez, M. I., Botto, E., & Kim, J. Y. (2024). Mapping Strategies for Reaching Socioeconomically Disadvantaged Populations in Clinical TrialsJAMA 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.


DiMasi J, Dirks A, Smith Z, Valentine S, Goldsack J, Metcalfe T, Grewal U, Leyens L, Conradi U, Karlin D, Maloney L, Getz K, Hartog B. Assessing the Net Financial Impacts of Employing Digital Endpoints in Clinical Trials. Clinical and Translational Science (revised; preprint server) Access article.

Harper B, Getz K, Karcher T. Back to (Communication) Basics: Reducing Site Burden & Establishing a Sponsor/CRO-of-Choice Relationship with Investigative Sites . DIA Global Forum. May 31, 2024. Access Article. 
Smith Z, DiMasi J, Getz K. New Estimates on the Cost of a Delay Day in Drug Development. TIRS. May 21, 2024. Access Article.
Kim JY, Ford RM, Shang Z. Mapping Baseline ChaptGPT Usage to Support Drug Development. Applied Clinical Trials. May 21, 2024. Access article.
Smith Z, Getz K. Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials. TIRS. May 11, 2024. Access Article.
To access a comprehensive list of published Tufts CSDD manuscripts and articles, visit Articles - Tufts CSDD
The Tufts CSDD team members are presenting at and attending the following conferences. Let's schedule a time to meet. 

July 2024

13th Clinical Trials in Oncology East Coast | Boston, MA

Measuring RBQM Adoption: Insights and Opportunities

Maria Florez  & Abigail Dirks  | July 9 


NIH Institutes of Health | Virtual Program

Engaging the Public as Partners in Clinical Research

Ken Getz | July 17


September 2024

Mobile in Clinical Trials | Philadelphia, PA 

Next-Generation Investment to Support Patients and Sites Remotely in Clinical Trials - Navigating the Landscape and Practical Steps for Success

Zak Smith | September 16  


Panel: Demonstrating the Value and ROI of Digital Technologies in Trials

Zak Smith (Moderator) | September 16  


DPHARM: Disruptive Innovations to Modernize Clinical Research | Philadelphia, PA

ROI Keynote: Examining Short & Long Term ROI from DCT Deployments

Ken Getz | September 17  


Tufts CSDD Reports on the Uptake of AI in Clinical Research: Trial Planning & Execution

Mary Jo Lamberti | September 18 


Global Site Solutions Summit | Hollywood, FL

Keynote on the Evolving Global Site Landscape

Ken Getz | September 29  

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