Negotiating industry-sponsored clinical trial agreements: a view from the trenches.
A number of possible factors, including issues of cost, enrollment, and time, contribute to the decline in the percentage of industry-sponsored clinical trials conducted in academic institutions as opposed to those conducted at for-profit entities. This piece focuses on the agreement negotiation process. If negotiators were given easier access to the sponsor's decision makers, it is likely that the negotiations would proceed more efficiently. Also noted are reports by academic investigators of difficulty in getting access to unblinded trial data, which are needed for patient care and publication.
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Office of Corporate Sponsored Research and Licensing, Massachusetts General Hospital, Charlestown 02129, USA. nzapol@partners.org
D002986:Clinical Trials as Topic / Q000592:standards*; D004345:Drug Industry / Q000592:standards*; D006801:Humans; D007373:Interinstitutional Relations; D014481:United States