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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Banner Insider Sept2024
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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trial or respond to an outreach campaign are lost, having elicited no response from site personnel or having received outdated and inaccurate clinical trial information.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.

On September 30, we will be hosting a special half-day in-person roundtable in Boston focusing on opportunities and solutions to optimize the regulatory submission process. Senior drug development professionals from pharmaceutical and biotechnology companies are invited to attend this no-cost workshop. However, space is limited to ensure a highly interactive and substantive discussion.  Please contact Sarah Wrobel (sarah.wrobel@tufts.edu) to learn more and to register.

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,

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Kenneth Getz

Executive Director, Tufts CSDD

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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.

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Share Your Experiences on the Regulatory Submission Process
The Tufts Center for the Study of Drug Development, Tufts University School of Medicine, is conducting a new study looking at trends, inefficiencies, and opportunities to optimize, the regulatory submission process.  As part of this research we’re conducting a global survey among clinical research and regulatory professionals. Please take a moment to share your experience.  As a thank you for your participation, we’ll send you a summary of the study findings, their implications and insights.  Click here to begin the confidential survey:
 
 

 

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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

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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. 

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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.

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 Digest August 2024

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

Dirks A. Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials Pharma Focus Asia. September 2024.  Access article.
 
Ralic D, Ford R, Monreal B, Vieyra K, Getz K. Documenting the Last Mile Leak in the Patient Recruitment Pipeline. DIA Global Forum.  September 2024. 
 
Getz K. The Relationship Between Participant Diversity and DCT Use in Clinical Trials. Applied Clinical Trials. September 2024.

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

 

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.

 

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