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:

 

The results of several Tufts CSDD studies received a lot of attention on LinkedIn and in the media this past month. There was active discussion about our recent analysis quantifying the cost of a day of lost prescription drug sales and the direct cost of a clinical trial day of delay. Several news outlets featured our recent results presenting use cases of AI/Generative AI in drug development and their associated time and cost savings. Social media discussion and an article in the trade press focused on our study assessing actual DCT component use and its effect on clinical trial timelines and enrollment performance.

As always, we’re very pleased to see stakeholder discussion, debate and reference to our study findings. And we appreciate recognition of the importance of empirical data in informing strategic management decisions.

It has been a very busy month of research project activity. Our working group study assessing the transition of high frequency, legacy monitoring to centralized/risk-based monitoring is underway as is our working group study looking at centralized recruitment strategies and their impact on enrollment. We are hard at work updating our estimates of phase transition probabilities and the capitalized cost to develop a single successful drug.

The Tufts CSDD research team has been working on a clinical data optimization study in collaboration with TransCelerate, several studies quantifying patient participation burden based on protocol design and execution elements, adoption and impact of risk-based quality management practices, and a working group study mapping the changing investigative site landscape. Next month we will be launching a new study looking at participant compensation strategies and their impact on enrollment effectiveness.

Please refer to the Tufts CSDD website or reach out to me directly (Kenneth.getz@tufts.edu) to learn more and to participate in any of the Center’s projects.

We want to welcome our students who registered for the Tufts CSDD’s 2025 Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation and attended our first session late last month. This virtual course will be held once a week through February. We also want to extend our appreciation to the outstanding line-up of faculty from industry and academia. Please refer to our website or contact Sarah Wrobel (Sarah.wrobel@tufts.edu) to learn about any of our professional development offerings including customized onsite and virtual programs.

We welcome your active engagement and collaboration.

Best regards,

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Kenneth Getz

Executive Director, Tufts CSDD

Upcoming Studies

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New Working Group Study Assessing How Companies are Transitioning from Legacy, High-Frequency to Risk-Based Study Monitoring

This study has launched with a large number of participants and will be examining how companies are approaching this transition, specific practices to systematically reduce SDV/SDR, implementation and change management challenges encountered, and experiences and impact of onsite and remote monitoring practices. For more information contact Ken Getz (Tufts CSDD — in collaboration with the Drug Information Association — is starting a working group study to assess how companies derive and implement compensation for their study volunteers.  The study will also assess the relationship between compensation practices — overall and by therapeutic area — and enrollment performance.  For more information contact Ken Getz (kenneth.getz@tufts.edu).

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New Working Group Study Examining Study Volunteer Compensation Practices

Tufts CSDD — in collaboration with the Drug Information Association — is starting a working group study to assess how companies derive and implement compensation for their study volunteers.  The study will also assess the relationship between compensation practices — overall and by therapeutic area — and enrollment performance.  For more information contact Ken Getz (kenneth.getz@tufts.edu).

Professional Development

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Tufts CSDD Custom Drug Development Courses

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. 

Participate in Tufts CSDD Pre-Competitive Consortia for Quantitative Evidence, New Insights and New Practices

PALADIN Consortium

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Mission:  To optimize patient advocacy group (PAG) and industry collaborations to transform the pace of new medicines development

Membership:  Currently 25 sponsor & PAG organizations

Contact Trish Davidson (Patricia.Davidson@tufts.edu) for more information and to join.

PACT: Partnership for Advancing Clinical Trials

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Mission:  To gather empirical data on the use and impact of virtual and remote solutions supporting clinical trial planning and execution

Membership:  Currently 34 sponsor and CRO companies

Contact Joan Chambers  (Joan.chambers@tufts.edu) for more information and to join. 

Research Highlights

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Tufts CSDD's January/February Impact Report
Use of Artificial Intelligence to Support Clinical Trial Activity Yields Time Savings of 18%

The January/February 2025 Impact Report (Volume 27, Number 1) provides evidence on the state of adoption of AI/ML in clinical development and its reported impact on cycle time improvements and efficiencies. The report also highlights investments that companies are making in AI/ML and barriers to adoption.

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.

Data Insights Digest

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

Recent Publications & Media Mentions

Getz K. Replacing Anecdotal with Empirical Evidence on the Impact of DCTs. Applied Clinical Trials. February 2025. https://www.appliedclinicaltrialsonline.com

 

Studna A. New Data Links Decentralized Clinical Trial Approaches to Improved Diversity in Patient Populations. Applied Clinical Trials. January 29, 2025. Access article.

 

Lamberti M, Rosner S. DIA/Tufts CSDD Research: AI Saving Time in Drug Development. DIA Postcast. January 17, 2025. Access podcast.

 

Kim J, Getz K. Is There Progress Amidst the Swinging Diversity Pendulum? Applied Clinical Trials.  January 14, 2025. Access article.

 

Buntz B. How a 'Rising Tide' of Inclusivity is Transforming Clinical Trials. Drug Discovery & Development. January 3, 2025. Access article.

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

 

Connect with Us

The Tufts CSDD team members are presenting at and attending the following conferences. Let's schedule a time to meet. 

 

February 2025

Mapping the Evolving Global Landscape of Investigative Site Models

Joan Chambers

SCOPE Summit 2025 | Orlando, FL | February 4

 

PANEL DISCUSSION: Enhancing Clinical Trials: Building Trust, Engagement, and Real-Time Impact

Abigail Dirks (Panelist)

SCOPE Summit 2025 | Orlando, FL |  February 4

 

Impact of PRO Type, Frequency and Modality on Patient and Site Burden: Insights from BMS/Tufts/ZS Research Study

Abigail Dirks

SCOPE Summit 2025 | Orlando, FL |  February 4

 

A Multi-Company Study Examining the Adoption and Use of AI 

Mary Jo Lamberti  & Maria Florez

SCOPE Summit 2025 | Orlando, FL | February 5

 

PANEL: Empowering Partnerships: Collaborating with Patients and Advocacy Groups to Accelerate Clinical Research

Joan Chambers (Panel Moderator) 

SCOPE Summit 2025 | Orlando, FL |  February 5

 

PANEL: Decentralized Clinical Trial Elements to Improve Participant Access and Representation

Abigail Dirks (Panelist)

SCOPE Summit 2025 | Orlando, FL |  February 5

 

DCT Collaborative Workshop

Ken Getz

Clinical and Translational Science Institute | Los Angeles, California | February 12

 

ROI on DCTS in Clinical Trials

Ken Getz

DPHARM Webinar | Virtual | February 20

 

View all previous & upcoming conferences and presentations.

 

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