Academic medical centers' standards for clinical-trial agreements with industry.
BACKGROUND
Although industry sponsors provide approximately 70 percent of the funding for clinical drug trials in the United States, little is known about the legal agreements that exist between industry sponsors and academic investigators. We studied institutional standards regarding contractual provisions that restrict investigators' control over trials.


METHODS
We used a structured, cross-sectional mail survey of medical-school research administrators responsible for negotiating clinical-trial agreements with industry sponsors.


RESULTS
Of 122 institutions approached, 107 participated. There was a high degree of consensus among administrators about the acceptability of several contractual provisions relating to publications. For example, more than 85 percent reported that their office would not approve provisions giving industry sponsors the authority to revise manuscripts or decide whether results should be published. There was considerable disagreement about the acceptability of provisions allowing the sponsor to insert its own statistical analyses in manuscripts (24 percent allowed them, 47 percent disallowed them, and 29 percent were not sure whether they should allow them), draft the manuscript (50 percent allowed it, 40 percent disallowed it, and 11 percent were not sure whether they should allow it), and prohibit investigators from sharing data with third parties after the trial is over (41 percent allowed it, 34 percent disallowed it, and 24 percent were not sure whether they should allow it). Disputes were common after the agreements had been signed and most frequently centered on payment (75 percent of administrators reported at least one such dispute in the previous year), intellectual property (30 percent), and control of or access to data (17 percent).


CONCLUSIONS
Standards for certain restrictive provisions in clinical-trial agreements with industry sponsors vary considerably among academic medical centers. Greater sharing of information about legal relationships with industry sponsors is desirable in order to build consensus about appropriate standards.
Mello
Michelle M
MM
Department of Health Policy and Management, Harvard School of Public Health, Boston, MA 02115, USA. mmello@hsph.harvard.edu
Clarridge
Brian R
BR
Studdert
David M
DM
D000046:Academic Medical Centers / Q000331:legislation & jurisprudence / Q000592:standards*; D035843:Biomedical Research / Q000191:economics / Q000331:legislation & jurisprudence / Q000592:standards; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D032982:Contracts / Q000592:standards*; D003430:Cross-Sectional Studies; D030881:Disclosure; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence*; D007373:Interinstitutional Relations; D015337:Multicenter Studies as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D017008:Negotiating; D011643:Publishing; D012109:Research Support as Topic; D011795:Surveys and Questionnaires; D014481:United States