As an independent, globally-focused, multidisciplinary academic team of researchers, Tufts CSDD conducts a variety of robust, data-driven assessments and analyses to derive new insights into strategies and practices that optimize drug development performance and efficiency. Each year, the Center’s research agenda focuses on priority and timely topics identified by Tufts CSDD faculty and based on suggestions by individuals or multiple organizations.
Research studies may entail fielding a survey; conducting interviews and in-depth individual and group discussions; gathering primary and secondary data; and performing sophisticated yet practical and highly relevant data analyses.
To support our mission as an academic research center, the results of all Tufts CSDD studies are published in peer-reviewed and trade journals. Tufts CSDD only publishes aggregate analyses — individual companies, specific drugs, and biologics, and proprietary information and experiences are never identified. Participating organizations may also receive customized reports comparing their performance, practice, and experience against aggregate industry benchmarks.
About Our Working Group Studies
Tufts CSDD is in a unique position to convene a group of companies looking to share experiences and data and to collectively review and discuss study findings and insights. These multi-company working group studies have generated compelling analyses, invaluable benchmarks, and novel insights into the drug development process as well as practices and solutions to drive performance improvement and efficiency.
Examples of recently completed and active individual- and working group-funded studies:
| NME drug development metrics by therapeutic class and molecule type | Remote-based clinical teams: performance and best practices | Clinical trial management technology and EDC systems practices and prevalence |
| Trends in drug and biologic approvals | Participant diversity, inclusion, and disparities in clinical trials | Outsourcing strategies and practices |
| Regulatory review cycle times and the impact of regulatory reform on performance | Adoption and use of hybrid and virtual/decentralized models supporting clinical trials | Personnel workload and capacity by R&D function |
| Preclinical cycle times and economics | The use and impact of machine learning and artificial intelligence (AI) in clinical research | FDA expedited development & review programs |
| Protocol design complexity and impact on site and patient participation burden | The use of genetic and biomarker data to inform development strategy | Orphan drug product protocol designs and development speed |
| Study conduct cycle times, patient recruitment and retention effectiveness | Impact of ICH E6 (R2) and E8 on functional operations and R&D operational risk | |
| Adoption and impact of patient engagement initiatives |
The following multi-company working groups are currently active:
To discuss a research topic of interest and for more information about individual studies and multi-companyworking group studies, please contact the Tufts CSDD research team.`
| TOPIC | STAGE | ENROLLMENT |
| Mapping & Quantifying Effectiveness of Central Recruit Methods Among Sponsor Organizations | Fielding Survey | Closed |
| New Segmentation of the Global Investigative Site Landscape | Designing Data Collection Instrument | Closed |
| Assessing the Transition from Legacy High-Frequency Study Monitoring to Centralized & Risk-Based Approaches & Its Impact | Designing Data Collection Instrument | Open |
| Updating Estimates on the Capitalized Cost to Develop a Single Successful Drug | Planning | Open |
| Evaluating Study Volunteer Compensation Practices & Their Impact on Enrollment Performance | Planning | Open |
| Updating Benchmarks on Protocol Design Practices & Complexity | Planning | Open |
Consortia
Consortia have been created within, and are facilitated by, Tufts CSDD. These multi-year, pre-competitive initiatives engage drug development stakeholders in gathering data, resources and insights to establish benchmarks and inform best practices. Two notable consortia at Tufts CSDD include:
Focus: To optimize patient advocacy group (PAG) and industry collaborations to transform the pace of new medicines development
Established: in 2022 with funding provided by Sanofi
Membership: Currently 25 sponsor & PAG organizations
Website: https://sites.tufts.edu/paladinconsortium/
Contact: Trish Davidson (@email) for more information and to join.
Focus: To gather and share empirical evidence on the actual use and impact of virtual and remote solutions supporting clinical trial planning and execution
Established: in 2023 with funding from the Reagan Udall Foundation for the Food and Drug Administration and Medable
Membership: Currently 34 sponsor and CRO companies
Website: https://sites.tufts.edu/pactconsortium/
Contact: Joan Chambers (@email) for more information and to join.