The document outlines the achievements, obstacles, and goals of clinical trial contracting at the University of California (UC). It discusses achievements like developing a comprehensive training program for negotiators and establishing agreements with several companies. Obstacles include sponsor demands conflicting with UC policies on issues like data ownership and subject injury. Goals are to establish more master agreements, improve key relationships, and enhance communication across the UC system.

1. 9/17/2012
Agenda
• Achievements
▫ Training
▫ Communication across the system
Clinical Trial Contracting at UC ▫ Agreements
Achievements, Obstacles and Goals • Obstacles to Negotiation
• UC policies vs. industry practices and policies
UC BRAID Retreat • Goals for 2012-2013
September 14, 2012
Hillary 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*
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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 subsidiaries
Sponsor Demands UC Constraints
▫ Alvine
Restricted use of biological samples Lack of funds and mechanisms to
restrict use ▫ Biogen Idec
Present assignment of intellectual UC needs the paper trail, to record ▫ Boehringer Ingelheim
property existence of invention and assign to ▫ Celgene
proper party
▫ Cook
No start up costs, no overhead for UC will incur a loss if these charges are
certain services not assessed ▫ Merck
Withholding all payment until data UC needs payment for expenses ▫ Medtronic
queries are resolved to sponsor’s properly incurred and work performed ▫ Otsuka
satisfaction
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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 You
Hillary Noll Kalay, JD, MPP
Research Policy Manager
Research, Policy Analysis & Coordination (RPAC)
UC Office of the President, Research & Graduate Studies
1111 Franklin Street, 11th Floor
Oakland, California 94607
Office: 510.987.0355
Fax: 510.987.9456
E-mail: hillary.kalay@ucop.edu
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