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:
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trial or respond to an outreach campaign are lost, having elicited no response from site personnel or having received outdated and inaccurate clinical trial information.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
Professional Development
Calling All Biopharmaceutical Companies: We Need Your Help (& Data)!
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.
Participating in the study is crucial for pharmaceutical and biotechnology companies to ensure that current, comprehensive data informs R&D strategies and regulatory discussions. Given the growth and significance of small firms in the biopharmaceutical landscape in recent years, we are making an effort in the current study to gather data additionally for the small firm sector. A new estimate is essential for guiding policymaking and fostering innovation in biopharmaceutical development worldwide.
To learn more and get involved, contact the study's principal investigator, Dr. Joseph DiMasi.
Upcoming Studies
Share Your Experiences on the Regulatory Submission Process
Working Group: Mapping & Quantifying Effectiveness of Central Recruit Methods Among Sponsor Organizations
The Tufts Center for the Study of Drug Development (Tufts CSDD) is forming a working group to map and quantify the effectiveness of central recruitment methods among sponsor organizations. Primary study objectives include quantifying central recruitment methods overall, and on a per-patient basis, by therapeutic area, itemizing primary central recruitment costs, and measuring the impact of these methods on recruitment and retention effectiveness.
For more information, contact Jennifer Kim Ph.D. and Mary Jo Lamberti, Ph.D.
Participate in Tufts CSDD Pre-Competitive Consortia for Quantitative Evidence, New Insights and New Practices
PALADIN Consortium
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
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
Tufts CSDD's September/October Impact Report
Participation Burden for Patients in Clinical Trials is Rising, Especially in Non-Oncology Studies
The September/October 2024 Impact Report (Volume 26, Number 5) is now available. This latest issue presents the results of Tufts CSDD's groundbreaking work on assessing patient participation burden in clinical trials. Conducted in collaboration with 14 pharmaceutical companies, the results characterize factors contributing to rising levels of participation burden and identify opportunities to reduce this burden and optimize protocol designs.
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
To access hard-hitting Tufts CSDD charts and tables, visit https://csdd.tufts.edu/impact-reports.
Recent Publications
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
Connect with Us
The Tufts CSDD team members are presenting at and attending the following conferences. Let's schedule a time to meet.
September 2024
FDA Diversity Action Plans: Deciphering the Guidance and its Consequences | Virtual
Panel Discussion (Webinar)
Joan Chambers | September 4
Clineco Webinar on the Financial Value of Development Time | Virtual
Quantifying the Value of a Delay Day
Ken Getz | September 10
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
CRAACO: Clinical Research as a Care Option | Philadelphia, PA
Insights from Tufts CSDD into Evolving Trial Partnership Models
Joan Chambers | 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
SDC Webinar on Patient Engagement | Virtual
Progress Report on the Patient Engagement Movement
Ken Getz | September 19
RBQM Live! | Virtual
Keynote: Unlocking the Path to RBQM Maturity
Ken Getz | September 24
ZS Leadership Meeting | Philadelphia, PA
Refining the Assessment of Patient and Site Burden in Clinical Trials
Ken Getz | September 25
Global Site Solutions Summit | Hollywood, FL
Keynote on the Evolving Global Site Landscape
Ken Getz | September 29
View all previous & upcoming conferences and presentations.