Industry-Sponsored Research Contracts:An Empirical Study

Mello, Michelle

Abstract

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The aim of this study is to examine policies, practices, and institutional norms concerning the allocation of control over various aspects of industry-funded clinical trials between academic investigators and sponsors. Industry funding has become an indispensable part of biomedical research, accounting for 70% of the funding for clinical drug trials in the U.S. While academic-industry research partnerships carry great benefits, the terms of the contracts between academic institutions and sponsors pose a possible threat to research integrity in that they may restrict investigators' academic freedom. There exists scant empirical data on the nature and consequences of these legal relationships. This study explores five research questions: (1) what institutional structures (such as formal policies and consultation with legal counsel) are in place in academic medical centers to negotiate contracts for industry-sponsored clinical trials? (2) How frequently do contracts between academic institutions and industry sponsors contain provisions relating to control over data, control over the conduct of the trial, control over publication, and confidentiality? (3) To what extent do contract officers and faculty view it as acceptable or unacceptable to cede control over each of these aspects of clinical trials to industry sponsors? (4) What is the incidence and nature of disputes with industry sponsors? (5) Do the answers to Questions 1 through 4 vary according to institutional and faculty characteristics (institutional size, faculty academic rank, faculty specialty, and percentage of funding from industry)? We hypothesize that respondents will report that allocation of control over many aspects of clinical trials to industry sponsors is acceptable, but that large institutions, institutions with formal policies governing industry-sponsored research, faculty with senior academic rank, and faculty with little industry funding will be less likely than other institutions and faculty to view sponsor controls as acceptable. We further hypothesize that the use of formal policies will be associated with a lower incidence of investigator-sponsor disputes. These hypotheses will be tested through a mailed survey of grants and contracts administrators and clinical faculty at academic medical centers. The survey will gather information on institutional policies and procedures, the acceptability of specific types of sponsor controls, disputes with sponsors, and perceived pressures in the research environment. The data will be analyzed descriptively and with chi-squared tests and regression analysis.