Sponsored Research at Tufts CSDD
As part of its broad research agenda, the Tufts Center for the Study of Drug Development conducts Sponsored Research on a wide variety of topics identified by individual or multiple companies. Sponsored Research typically focuses on operational or R&D management issues, and may entail creation of a multi-company working group, survey creation, collection of company data, and publication of aggregate analyses. Individual participating companies may also receive customized reports, comparing their benchmarks against an industry mean.
Tufts CSDD brings broad expertise, creativity, and over 35 years of experience to its Sponsored Research program. Here are some examples of what we offer:
- Primary and Secondary Research - including surveys, executive and opinion leader interviews, focus groups, and original and secondary data analyses.
- Facilitated Roundtables and Management Meetings - including small and large group conference-style presentations and moderated discussions held onsite at the sponsor organization or at a neutral location (for example at Tufts CSDD’s own conference facility).
- White Papers and Custom Management Reports - including the compilation of source information, and the review and analysis of significant R&D trends. Tufts CSDD will work closely with the sponsor organizations throughout the process. At the conclusion of the project, Tufts CSDD will prepare a summary report* that may be submitted for publication in a trade or peer-review journal, as well as customized reports for sponsoring organizations.
* Note that the Tufts Center for the Study of Drug Development publishes aggregate analyses only; individual companies, drugs, and proprietary data are never identified.
The following are examples of Sponsored Research recently conducted by Tufts CSDD:
- Benchmark study on capacity planning, economics, and forecasting [Multi-Company Working Group]
- Market sizing, structure, and trends analysis
- Clinical trial efficiency assessment: analysis of protocol complexity and amendments [Multi-Company Working Group]
- Quantitative assessment of the impact of clinical outsourcing on development performance, quality, and cost [Multi-Company Working Group]
- Assessment of various R&D strategies and management practices
- Long-range projection on adoption of new practices, technologies, and innovations
- Opportunities for improved R&D efficiency and effectiveness [Multi-Company Working Group]
Multi-Company Working Groups
Meeting industry’s goal of improved R&D efficiency often depends on the willingness of individual companies to share with their industry peers insights gleaned from experiences with different R&D operating models and strategies. Moreover, by sharing internal drug development metrics, timely and reliable industry-wide benchmarks can be generated, which can lead to operational changes and improved performance.
As an independent and neutral academic research group, Tufts CSDD is in a unique position to convene such a group of companies, collect and analyze proprietary data, solicit insights, and prepare objective reports. We call this our Multi-Company Working Group program, and it has led to the creation of many compelling analyses, invaluable benchmarks, and novel insights into the drug development process.
Studies Currently Open for Company Enrollment
Multi-Company Working Groups meet at Tufts CSDD offices in Boston to refine project goals, finalize surveys, review results, and generate discussion and insight. Note that Tufts CSDD will only share aggregate data and analyses; individual companies, drugs, and proprietary data are never identified. The following Multi-Company Working Group projects are just getting underway:
**NEW** Working Group Study Commitment Letter to Develop Standard Practices and Policies for Optimizing Social Media Communities in Clinical Research
Kick-off: March 20, 2013
Study Overview: The emergence of interactive web based communities has introduced a host of opportunities and major challenges with respect to patient recruitment and communication, data integrity and pharmacovigilance. Although these communities play a growing role in clinical research, no standard policies and practices have been established to guide clinical research professionals. Tufts CSDD has now constituted a working group of nearly two dozen companies to develop a comprehensive set of proposed principles and standard practices.
Process: A kick-off meeting is scheduled in Boston at the Tufts CSDD offices on March 20th, 2013 where participants will discuss and refine Working Group objectives and deliverables and establish subcommittees.
Specific committee and subcommittee objectives will include: capturing and prioritizing case examples; articulating management policies and procedures and best practices with respect to pharmacovigilance, safety, data and research integrity; identifying potential solutions for leveraging social networking content.
At the conclusion of the study, Tufts CSDD and the working group will prepare a report containing comprehensive recommendations for each participating organization and a summary report for industry-wide review.
The agenda for the Boston meeting is as follows:
- Welcome, Introductions and Context-Setting (10 - 10:30am)
- Discuss and Refine Working Group Aims, Mission, Charter and Deliverables (10:30 - noon)
- Establish Subcommittees and their Individual Objectives, Activities and Deliverables (noon - 2:45pm)
- Reiteration of Next Steps (2:45 - 3pm)
Participating companies are sending more than one representative. Functions represented include pharmacovigilance and safety, clinical operations, patient recruitment, clinical development, medical affairs and policy. During the kick-off meeting, we will discuss ideal participation inputs from key internal functions as well as how to best engage regulatory agencies, social media experts and other stakeholders to inform the working group.
Participation Details: For more details, or to participate in the study, contact Stella Stergiopoulos at Tufts CSDD.