Tufts CSDD Publishes Record Number of Manuscripts & Hosts First Ever Research Symposium to Honor Former Director
Tufts Center for the Study of Drug Development
An Independent, Academic, Non-profit Research Center at Tufts University School of Medicine in Boston, Massachusetts.
Dear CSDD Friends:
Center faculty and staff published a record number of manuscripts and articles this past month.? One in particular — looking at the value of a single day of delay — resonated immediately with drug development professionals as evidenced by the number of emails we received and the number of references posted in social media.? Based on a robust analysis of 645 drugs and biologics launched since 2000, the Tufts CSDD team estimates that a delay day is now worth approximately $500,000 in unrealized or lost prescription drug sales.? This estimate is a tenth of the widely cited and antiquated $5-million-per-day figure and indicates a sharply declining return-on-development investment now associated with high and rising risk of failure in R&D.
The team also estimated the average direct daily cost of a clinical trial.? Tufts CSDD analyzed budgets for 409 recently completed clinical trials and estimates that a day of delay in a clinical trial is worth $40,000 in direct costs. This estimate of a delay day is less than half the inflation-adjusted figure published in the mid- 1990s and suggests that certain direct costs may be lower today (e.g., operating, procedural and technology costs) and that sponsors and CROs are placing significant pressure on investigative sites to operate more efficiently and work harder for lower relative study grant amounts.? Please refer to the list of recent publications below to access our newest manuscript and articles.
Our project pipeline is very busy at this time.? We recently launched a study looking at the underlying reasons and motivations for dose non-adherence in clinical trials and we have more than a dozen studies underway including one that is gathering use cases of generative AI supporting drug development and another looking at the time and resources dedicated by sponsors, service providers and investigative sites to support the vendor qualification process.? With respect to this last study, we have received a strong response from service providers and sites; we encourage more sponsor companies to complete the online survey.? Please click here to participate.
This has also been a very productive period for the PALADIN and PACT consortia (the former focusing on practices and resources driving more effective and efficient patient advocacy group – industry collaborations, the latter focusing on gathering and analyzing actual experience deploying decentralized clinical trial solutions) and for our custom professional development programs.
I encourage you to review this Insider and visit the Tufts CSDD web site for more information about these initiatives and others.? And, as always, please reach out to me directly?with feedback, ideas and inquiries.
Best regards,
Kenneth Getz
Executive Director & Professor
News of Note
On June 3rd, professionals from the drug development industry and academia convened in Boston for the New Medicines Development at a Crossroads: Trends and Transformation in Drug Development symposium, commemorating Professor Ken Kaitin 's distinguished 38-year career at Tufts CSDD. The symposium began with a keynote presentation on "Navigating a Changing Pharmaceutical Landscape: Ensuring Access to Breakthrough Medicines" given by Professor Kenneth Kaitin. His presentation set the stage for the afternoon sessions, which encompassed insightful historical perspectives, discussions on emerging initiatives at the Center for Clinical Trial Innovation (C3TI) at the FDA led by Kevin Bugin , and a stimulating panel on Trends Driving Transformation on the Horizon, featuring industry experts Murray Aitken , Dr. Lindsay McNair, MD, MPH, MSB , Robert Franco, PhD , and Ken Getz , who delved into topics such as AI, DEI, & DCTs.
?For access to the event video, kindly reach out to our Communications Coordinator, Ava Feuer ([email protected] ).
Professional 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, MHA ([email protected] ).
Upcoming Studies
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 [email protected] . Thank you in advance for your participation in this important research effort!
Vendor Qualification Assessment (VQA) Survey
Tufts CSDD is also conducting an important empirical study looking at the time and cost of the vendor qualification assessment process to all stakeholders involved — including those who issue RFIs/RFPs and conduct qualifications and those who respond to them. ?To complete a survey, please choose the appropriate questionnaire:
All responses are confidential and will only be presented in the aggregate - no individual or organization will be identified. Tufts CSDD will send you a summary report of the results as a thank you for your participation.
Research Highlights
领英推荐
Tufts CSDD May/June Impact Report: Use of Digital Endpoints to Collect Clinical Trial Data is Rapidly Increasing
The May/June 2024 Impact Report(Volume 26, Number 3) is now available. The issue presents new research on the increased usage of digital endpoints as a data collection method in clinical trials.
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
Recent Publications
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.
Lamberti MJ, Dirks A, Kikuchi N et al. Benchmarking Site Activation and Patient Enrollment. TIRS.?April 3, 2024. ?Access Article
To access a comprehensive list of published Tufts CSDD manuscripts & articles, please 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.
June 2024
DIA Annual Meeting | San Diego, CA
June 17 | Having the End in Mind: Building Quality into Clinical Trials | Ken Getz
June 18 | An Update on the PALADIN Consortium | Ken Getz
June 19 | Workshop: Improving Communication Across Differences in Drug Development Teams | Jennifer K. & Emily Botto
June 20 | Regulatory Affairs of the Future: Is Now | Maria I. Florez
June 20 | Panel: The Impact of Racial Discrimination on the Patient Clinical Trial Experience | Host: Jennifer K. & Panelist: Ruby Ford, MPH
Public Health & Community Medicine, TUSM | Boston, MA
June 20 | Benchmarking Patient Enrollment and Examining Recruitment and Retention Strategies in Clinical Trials?| Mary Jo Lamberti
Department of Public Health & Community Medicine, TUSM | Boston, MA
July 2024
13th Clinical Trials in Oncology East Coast | Boston, MA
July 9 | Measuring RBQM Adoption: Insights & Opportunities | Maria I. Florez ? & Abigail Dirks, MS
Become Involved with Tufts CSDD
Become a Corporate Sponsor or donate to support our critical mission of providing data-driven analysis and strategic insight to improve the efficiency and productivity of pharmaceutical development.
Visit our website to learn more about Tufts CSDD and how you can get involved.
Well done Ken and team! You all provide an invaluable service to this industry.