title: Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors.
abstract: We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.
authors.affiliation: Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Ave., Boston, MA 02115, USA. mmello@hsph.harvard.edu
authors.forename: Michelle M
authors.initials: MM
authors.lastname: Mello
authors.forename: Brian R
authors.initials: BR
authors.lastname: Clarridge
authors.forename: David M
authors.initials: DM
authors.lastname: Studdert
mesh_terms: D000288:Administrative Personnel / Q000191:economics / Q000523:psychology; D001290:Attitude; D002986:Clinical Trials as Topic / Q000191:economics* / Q000941:ethics; D016265:Conflict of Interest / Q000191:economics; D032982:Contracts / Q000941:ethics / Q000592:standards*; D003625:Data Collection; D005180:Faculty, Medical; D017408:Guidelines as Topic; D006801:Humans; D007221:Industry / Q000191:economics; D033181:Information Dissemination; D016134:Organizational Policy; D011643:Publishing / Q000941:ethics / Q000592:standards; D012107:Research Design; D012108:Research Personnel / Q000191:economics* / Q000523:psychology*; D012109:Research Support as Topic; D012577:Schools, Medical; D011795:Surveys and Questionnaires; D014481:United States