RELATIONSHIPS BETWEEN SPONSORS AND INVESTIGATORS IN PHARMACOECONOMIC AND CLINICAL RESEARCH

Potential conflict between the goals of the investigators and the spon sors of pharmacoeconomic and clinical research has been well documente d. Although there have been efforts to formalise relationships between sponsors and investigators in some areas of clinical research, no set of guidelines or standardised contract to govern pharmacoeconomic res earch relationships is currently in use.In this paper, we discuss a nu mber of provisions that should be included in a sponsored research agr eement to define the responsibilities and clarify the rights of the pa rties in the collaborative research relationship. We also present an e xample of a sponsored research agreement that we have designed as a mo del formal contract between sponsors and investigators. The most salie nt areas in the research agreement include: publication, specification of analysis, data access/ownership, confidentiality, termination and payment to investigators. While this paper focuses on pharmacoeconomic research, many of the principles have relevance to a broader range of research relationships and to other clinical economics and clinical t rials research.