UC BRAID Clinical Trial; Contracting


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Clinical Trial Contracting at UC

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UC BRAID Clinical Trial; Contracting

  1. 1. 9/17/2012 Agenda • Achievements ▫ Training ▫ Communication across the systemClinical Trial Contracting at UC ▫ AgreementsAchievements, Obstacles and Goals • Obstacles to Negotiation • UC policies vs. industry practices and policiesUC BRAID Retreat • Goals for 2012-2013September 14, 2012Hillary Noll Kalay ▫ More master agreements ▫ Improve relationships with certain companies ▫ Improve communication across UC Achievements: Greater Achievements: Training Communication and Collaboration• Developed comprehensive, 11-module training program for clinical trial negotiators across UC• Covers: ▫ Overview of phases of clinical trials, classes of devices ▫ Laws and regulations ▫ UC’s policies ▫ Negotiation do’s and don’ts of clinical trial agreements Achievements: Greater Achievements: Agreements Communication and Collaboration (9/2011 – 9/2012)• Sharepoint site • Abbott ▫ Discussion board • Allergan ▫ Agreements in negotiation • Bayer ▫ Resources • AstraZeneca• Working groups • Gilead ▫ Budgeting • Merck ▫ Device Trials • Novartis • Pfizer • Pharmacyclics* 1
  2. 2. 9/17/2012 Obstacles to Agreements: Obstacles to Agreements Sponsor Demands vs. UC Legal/Accreditation Requirements • Not negotiating directly with decision-makers ▫ CROs: will often not honor terms of masters Sponsor Demands UC’s Obligations • Negotiation of contract AND budget Keep terms of the agreement, budget, UC must disclose public records, etc. confidential unless exempt under law • Study team completion of paperwork Access to protected health information Access must comply with federal and • Demands of sponsors vs.: state law ▫ Legal obligations (as a research site, public IP extending beyond performance of the Bayh-Dole, UC’s obligations to other study research funders institution) No notification of adverse events Must have access to records post- ▫ Principles and policies of the University following study closure, no access to study; accreditation requires study records provided to Sponsor notification of adverse events following ▫ Realities of UC as a large, public institution following study study closure Obstacles to Agreements: Obstacles to Agreements: Sponsor Demands vs. Sponsor Demands vs. University Policies and Principles University Policies and Principles • The goals of our policies: Sponsor Demands UC Policies and Principles No payment for subject injury Policies require reimbursement for • To promote research injuries that directly result from studies • To make advances available to the public Ownership of raw data UC must own raw data • To leave the subject in no worse position (physical or Right to edit publications UC and its researchers must have control financial) for participating in the research over publication Everything related to the study must Confidentiality terms cannot interfere be kept confidential with publication rights; principle of open academic environment No “related” research Research of one investigator cannot affect the research of another Will only register study as required by ICMJE registration guidelines federal law Obstacles to Agreements: UC is a large public research Goals institution • More master agreements ▫ Abbott device subsidiariesSponsor Demands UC Constraints ▫ AlvineRestricted use of biological samples Lack of funds and mechanisms to restrict use ▫ Biogen IdecPresent assignment of intellectual UC needs the paper trail, to record ▫ Boehringer Ingelheimproperty existence of invention and assign to ▫ Celgene proper party ▫ CookNo start up costs, no overhead for UC will incur a loss if these charges arecertain services not assessed ▫ MerckWithholding all payment until data UC needs payment for expenses ▫ Medtronicqueries are resolved to sponsor’s properly incurred and work performed ▫ Otsukasatisfaction 2
  3. 3. 9/17/2012 Goals Goals• More master agreements • More master agreements• Improve relationships with key companies • Improve relationships with key companies ▫ Example: Johnson & Johnson • Improve communication across UC  Address each party’s concerns regarding: ▫ Campus to Campus:  Data and IP ownership  More advanced training  Research restrictions  SharePoint, work groups  Scope of confidential information  Single system-wide database?  Subject injury and indemnification ▫ External RPAC website Contract Repository Goals • More master agreements • Improve relationships with key companies • Improve communication across UC ▫ Negotiator to PI, PI to Negotiator:  Knowledge of PI’s communications with sponsor  PI training?  Others? Thank YouHillary Noll Kalay, JD, MPPResearch Policy ManagerResearch, Policy Analysis & Coordination (RPAC)UC Office of the President, Research & Graduate Studies1111 Franklin Street, 11th FloorOakland, California 94607Office: 510.987.0355Fax: 510.987.9456E-mail: hillary.kalay@ucop.edu 3