NEGOTIATING AND IMPLEMENTING MASTER CLINICAL TRIAL AGREEMENTS Justine

NEGOTIATING AND IMPLEMENTING MASTER CLINICAL TRIAL AGREEMENTS Justine Gordon – Moderator Research Foundation for The State University of New York Leigh Gentilcore Stony Brook University Mont Brownlee JHMI Clinical Trials Office

Objectives • Learn how to identify when and what type of Master Clinical Trial Agreement is appropriate • Understand who needs to be brought into the discussion • Discover the biggest obstacles to the negotiations and how these can be managed or overcome

What is a Master Clinical Trial Agreement • An agreement which articulates agreed-upon terms and conditions between a university and a sponsor, which can then be used as a basis for future projects with that sponsor

Types of MCTAs • Investigator-Initiated Study (IIS) • Sponsor-Initiated

Who Initiates • Sent from industry to institution • Go out blind to initiate MCTAs

Typical Provisions • • • Intellectual Property Publication Indemnification Confidentiality Subject Injury

Multiple MCTAs with the Same Company? • Both IIS and Sponsor-initiated • MCTA by phase

Clinical Research Organizations • How do CROs fit into the picture?

Alternatives to MCTAs • Model/Template Agreement

Regulatory Considerations • Magi • Pharma Guidelines

Case Studies • Special Circumstances • Mergers/Buyouts/Transitions

Resources

Questions?

Contact US Leigh Gentilcore, MBA Clinical Trials Administrator Office of Sponsored Programs W 5510 Melville Library Stony Brook, NY 11794 -3362 631 -632 -4949 Leigh. Gentilcore@stonybrook. edu Mont Brownlee, III, J. D. Associate Director, Contracting Office of Research Administration The Johns Hopkins School of Medicine 1629 Thames St, Suite 200, Baltimore MD 21231 410 -502 -0232 fbrownl 1@jhmi. edu Justine Gordon, CRA Associate Director Grants & Contracts Administration The Research Foundation for SUNY 35 State Street Albany, NY 12207 518 -434 -7105 justine. gordon@rfsuny. org