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]

**PARTICIPATE IN A SURVEY: Assessing the Adoption of Facilitated Protocol Feasibility Reviews**

Tufts CSDD is following-up on its recent Protocol Design Complexity study.  In collaboration with Medidata Solutions, we have created a survey to learn more about best practices from sponsors who have implemented/have begun implementing facilitated feasibility reviews of their draft protocols.  The survey is designed to take no more than 10 minutes to complete, and those who participate can enter for the chance to win a $50 Visa gift card.  All participants who enter to win will receive a summary report of the aggregated, benchmark results.

The survey can be found here and is available until August 19.

Your participation will provide us with valuable information on ways that life sciences organizations are optimizing the study design process. All data will be reported in the aggregate only to ensure company confidentiality.

If you have any question, comments or concerns regarding the survey, please email .(JavaScript must be enabled to view this email address).

 

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.

**NEW WORKING GROUP: eClinical Trials and Standards Adoption Working Group**

Much has changed over the past decade regarding implementation of industry-wide eClinical trials (eCT) solutions and standards. The passage of FDASIA (Food and Drug Safety and Administration Act) in 2012 allows the FDA to require biopharmaceutical companies to submit standardized electronic submissions through a phased-in process of guidance to the industry.  As a result, we're seeing organizations re-evaluate their current implementation of CDISC standards and adoption of technology through various approaches. To document and examine these organizational initiatives, Tufts CSDD is spearheading a new study in collaboration with CDISC. The study will be designed to examine and gather baseline data on the usage of eCT solutions and standards.  eClinical spans a number of areas and has led to solutions that create improvements and efficiencies; however, this also poses a number of challenges. Tufts CSDD will examine current and projected usage of eClinical by type of activity, task or program, and gather perceptions and attitudes about technology and standards adoption.  This study will also gather data on the impact of these solutions and standards on drug development performance and efficiency and explore future areas of convergence.  

Participating companies will work together to design the study methodology. Working collaboratively with CDISC, Tufts CSDD will facilitate the working group process, implement the data collection activity, gather and analyze the data and prepare a preliminary report to review and discuss with the working group. The working group will be comprised of a select group of pharmaceutical and biotechnology companies and CROs that are interested in sharing ideas, insights and data in order to develop more accurate, validated metrics to guide  management decision-making. In total, Tufts CSDD hopes to engage 15 to 20 companies in the Steering Committee and we are looking for each participating company to provide modest support to cover Tufts CSDD staff time and travel costs.

To our knowledge, no robust study has recently quantified and benchmarked eClinical solutions and standards; this is an excellent time to conduct one. Prior studies conducted by Tufts, CDISC and CenterWatch will be used for baseline data as appropriate. Two face-to-face meetings of the Steering Committee will be held, one at the beginning of the project to discuss the methodology and metrics to collect and the second meeting to discuss the preliminary study results and their implications and insights. Tufts CSDD invites your company to participate in this exclusive and intensive exercise. We look forward to speaking with you about this exciting and important project in more detail.
 
Participation Details: Please contact Mary Jo Lamberti if your company would like to work with us on this critical study.

If you have any questions or would like addition information regarding Sponsored Research or Multi-Company Working Groups, please .(JavaScript must be enabled to view this email address).

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