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:

 

We begin the new year with many compelling trends unfolding as operating pressures to lower costs and increase efficiency intensify. These trends promise to optimize and transform drug development processes and performance: cautious and growing use of AI/ML and generative AI; rising levels of customization in protocol design and clinical trial execution; increasingly integrated and agile approaches to utilize infrastructure, data, personnel and external collaborations.

Transformational trends, strategies and practices drive Tufts CSDD’s 2025 agenda. And we’re very excited about this year’s portfolio of activity (here’s a partial list):

  • Assessing patient and site participation burden in traditional and DCT-enabled clinical trials
  • Quantifying the return on investment in deploying risk-based quality management components
  • Evaluating strategies and practices to optimize protocol design and clinical data management
  • Examining the transition from legacy high-frequency study monitoring to centralized and risk-based monitoring
  • Mapping the global investigative site landscape, recognizing new clinical trial execution segments (e.g., local facilities and retail pharmacies)
  • Assessing trends, issues, and best practices associated with workforce and patient recruitment effectiveness
  • Measuring the adoption of DCT solutions use and its impact on clinical trial performance
  • Evaluating study volunteer compensation practices and their association with enrollment performance
  • Updating benchmarks on protocol design complexity in traditional and rare disease conditions

Please reach out to me directly (Kenneth.getz@tufts.edu) for more information and to participate in any of these projects.

At the end of this month, we begin Tufts CSDD’s 2025 Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation. Now celebrating its 52nd anniversary, this internationally-recognized program provides R&D professionals of all levels with a comprehensive overview of the drug development process, strategies and best practices to optimize performance.  Outstanding speakers from industry and academia share their expertise to create a highly stimulating and rewarding learning environment. Many organizations are taking advantage of our group registration discounts and sending multiple staff. Please contact Sarah Wrobel or visit our website to register and for more information.

Lastly – I point your attention to our January/February 2025 Impact Report. This newest issue presents the results of a recent empirical study measuring the adoption and impact of AI/ML and offers insights into use cases delivering compelling time savings. You can access the Impact Report on the CSDD website.

As always, we welcome your feedback and ideas. We look forward to collaborating with you in 2025!

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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

Reg Open

Last Chance to Register!

Registration for the 52nd Annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation, scheduled virtually on Thursdays from 11 am - 3 pm EST: January 30, February 6, February 13, and February 20, will close on January 17, 2025.
 
This unique course prepares both new and experienced professionals for success in the life sciences sector by providing a comprehensive overview of the pharmaceutical development process. It focuses on key topics vital to professionals involved in all aspects of bio-innovation, especially as the industry rapidly evolves.
 
“Taking the Tufts CSDD course was an incredibly beneficial experience. I gained so much knowledge…The speakers and presentations were fantastic.” - Director, Clinical Development
 
Organizations registering three or more colleagues can benefit from group rates. For details, please contact Sarah Wrobel at sarah.wrobel@tufts.edu. For more information about the 4-day virtual course, please visit Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation or email csdd@tufts.edu.  Don’t miss this opportunity to enhance your expertise!

 

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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Introducing 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) is now available. Tufts CSDD’s most recent Impact Report 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

Data Digest January 2025-1

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

Recent Publications

Getz K. Popular Culture and Clinical Research Literacy. Applied Clinical Trials.  December 11, 2024. Access article.

Blaustein M, Getz K. ROI and Rare Disease: Retooling the Gene Value Machine. Pharmaceutical Executive. November 2024. Access article.

Kim J, Palmer E, Galindo J, Sfera D. Case for the Underdog: Unleashing the Potential for Small, Community-Based Research Sites. Applied Clinical Trials.  December 5, 2024. Access article.

Grabowski H, DiMasi J, Long G. Postapproval Innovation For Oncology Drugs and the Inflation Reduction Act. Health Affairs. October 8, 2024. Access article.
 
Zhang V, Getz K. Trends in Patient Recruitment Advertising From 2012-2019. Applied Clinical Trials.  September 25, 2024. 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. 

January 2025

AI/ML in Plain Language Communications

Ken Getz

Center for Information and Study on Clinical Research Participation Webinar | Virtual | January 22

 

Delve Into Aspects of RBQM Maturity

Maria Florez  & Abigail Dirks

5th Risk-Based Quality Management Summit | Philadelphia, PA | January 29

 

February 2025

Mapping the Evolving Global Landscape of Investigative Site Models

Joan Chambers

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

Ken Getz (Panelist)

SCOPE Summit 2025 | Orlando, FL |  February 5

 

DCT Collaborative Workshop

Ken Getz

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

View all previous & upcoming conferences and presentations.

 

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