Background Although industry sponsors provide approximately70 percent of the funding for clinical drug trials in the UnitedStates, little is known about the legal agreements that existbetween industry sponsors and academic investigators. We studiedinstitutional standards regarding contractual provisions thatrestrict investigators' control over trials.
Methods We used a structured, cross-sectional mail survey ofmedical-school research administrators responsible for negotiatingclinical-trial agreements with industry sponsors.
Results Of 122 institutions approached, 107 participated. Therewas a high degree of consensus among administrators about theacceptability of several contractual provisions relating topublications. For example, more than 85 percent reported thattheir office would not approve provisions giving industry sponsorsthe authority to revise manuscripts or decide whether resultsshould be published. There was considerable disagreement aboutthe acceptability of provisions allowing the sponsor to insertits own statistical analyses in manuscripts (24 percent allowedthem, 47 percent disallowed them, and 29 percent were not surewhether they should allow them), draft the manuscript (50 percentallowed it, 40 percent disallowed it, and 11 percent were notsure whether they should allow it), and prohibit investigatorsfrom sharing data with third parties after the trial is over(41 percent allowed it, 34 percent disallowed it, and 24 percentwere not sure whether they should allow it). Disputes were commonafter the agreements had been signed and most frequently centeredon payment (75 percent of administrators reported at least onesuch dispute in the previous year), intellectual property (30percent), and control of or access to data (17 percent).
Conclusions Standards for certain restrictive provisions inclinical-trial agreements with industry sponsors vary considerablyamong academic medical centers. Greater sharing of informationabout legal relationships with industry sponsors is desirablein order to build consensus about appropriate standards.
Source Information
From the Department of Health Policy and Management, Harvard School of Public Health (M.M.M., D.M.S.); and the Center for Survey Research, University of Massachusetts (B.R.C.) — both in Boston.
Address reprint requests to Dr. Mello at the Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Ave., Boston, MA 02115, or at mmello{at}hsph.harvard.edu.
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