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Contract Pilot Data Presentation

Contract Pilot Data Presentation. Adam P. Rifkind, Esq. Associate Director, Corporate Contracts Office of Research Services University of Pennsylvania P-221 Franklin Building 3451 Walnut Street Philadelphia, PA 19104-6205 www.upenn.edu/researchservices/ rifkind@upenn.edu

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Contract Pilot Data Presentation

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  1. Contract Pilot Data Presentation Adam P. Rifkind, Esq.Associate Director, Corporate ContractsOffice of Research ServicesUniversity of PennsylvaniaP-221 Franklin Building3451 Walnut StreetPhiladelphia, PA 19104-6205www.upenn.edu/researchservices/ rifkind@upenn.edu Phone: 215 898-9990Fax: 215 898-0403 Libby D. Salberg, B.A., J.D. Director, Office of Grants & Contracts Management Vanderbilt University Medical Center 3319 West End Avenue, Suite 100 Nashville, TN 37203-6968 http://www.mc.vanderbilt.edu/gcm libby.salberg@vanderbilt.edu Phone: 615 322-7400 Fax: 615 322-7405

  2. We would like to thank the following for all of the help they provided throughout our attempts to accomplish our mission; • Dr. Daniel Rosenblum • Dr. Lili Portilla • Paymon Hashemi • REDcap team at Vanderbilt, • All the member Institution data coordinators • Our fellow Contracts Committee members • Nick Gaich of Stanford University.

  3. Overview Purpose • Develop objective metrics to be used for process improvement across the CTSA Consortium. Objectives • Collect defined time data points at all CTSA sites • Determine median and completion times for execution. • Obtain information on factors that may influence contract negotiation times.

  4. Why are we studying contracts negotiation? • An area of high concern for the CTSA Consortium are delays in starting clinical trials and the potential for contracts negotiation to contribute to delays. What do we hope to learn? • The CTSA Consortium will measure the time it takes to execute (have both parties sign) contracts for clinical trials at each site as a means to gain knowledge and improve process.

  5. How did we choose the data points? • Tracking ability • Commonality of usage • Other data points may be used going forward. How will the information be used? • Improve timelines for contracts negotiation. • Look at processes with a view towards improvement. • Use the Pilot Study to develop methods of data collection, identify obstacles to collecting data, and to inform the design of future studies.

  6. When did the study start? • The study started April 1, 2009. When will the study end for a site? • The study will end when a site has recorded the execution date of 90% of the contracts that site was tracking in the study. When will the study end? • The study will end when every site has recorded the execution date of 90% of the contracts that site was tracking in the study.

  7. What contracts are tracked in the study? • Our focus was on industry-initiated, industry-sponsored clinical trials. The inclusion and exclusion criteria are contained in the protocol (available on the CTSA Wiki). • Protocol adjustment was made to extend the enrollment period from the month of April 2009 to the end of May 2009, because of the ARRA.

  8. Sample Questions or Issues Thus Far • What if a study is withdrawn? • How do you classify clinical trial devices if they do not fall into classically defined Phase I, II, III, and IV drug trials? • At our institution, contracts are not executed until IRB approval. How will this be reflected in the study?

  9. Thank you for your time.Any questions? Adam P. Rifkind, Esq.Associate Director, Corporate ContractsOffice of Research ServicesUniversity of PennsylvaniaP-221 Franklin Building3451 Walnut StreetPhiladelphia, PA 19104-6205www.upenn.edu/researchservices/ rifkind@upenn.edu Phone: 215 898-9990Fax: 215 898-0403 Libby D. Salberg, B.A., J.D. Director, Office of Grants & Contracts Management Vanderbilt University Medical Center 3319 West End Avenue, Suite 100 Nashville, TN 37203-6968 http://www.mc.vanderbilt.edu/gcm libby.salberg@vanderbilt.edu Phone: 615 322-7400 Fax: 615 322-7405

  10. Contract Pilot Data Presentation Data Collection Update: June 22nd, 2009 Nick Gaich, B.A. Executive Director, Chief Operating Officer Stanford University School of Medicine 555 Middlefield Road Menlo Park, Ca 94025-3443 http://www.sccter.stanford.edu ngaich@stanford.edu Phone: 650 736-1875 Fax: 650 498-7564

  11. Current Landscape • Organizational Commitments • Organizational Submissions • # Contracts under study • Contract Maximum per Organization: 25 • 39 • 30 • > 498 • Summary Breakdown: • 2 Organizations exceeded maximum: • 10 Organizations at maximum • 4 Organizations : 20-24 range • 4 Organizations: 15-19 • 4 Organizations: 10-14 • 6 Organization: 1-9

  12. Early Observations

  13. Early Observations

  14. Early Observations Studies Completed 69 Range/Days: Low: 0 “same day” High : 69

  15. Key Characterics of Finished Agreements Number Percent Modeled from Master Template/existing CT Agreement ? Includes a Contract Research Organization (CRO) ? Multicenter Study ?

  16. Next Step Reporting Organizational Drill Down

  17. Thank you for your time.Any questions? Nick Gaich, B.A. Executive Director, Chief Operating Officer Stanford University School of Medicine 555 Middlefield Road Menlo Park, Ca 94025-3443 http://www.sccter.stanford.edu ngaich@stanford.edu Phone: 650 736-1875 Fax: 650 498-7564

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