Relationships between sponsors and investigators in pharmacoeconomic and clinical research.

Potential conflict between the goals of the investigators and the sponsors of pharmacoeconomic and clinical research has been well documented. 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 research relationships is currently in use. In this paper, we discuss a number of provisions that should be included in a sponsored research agreement to define the responsibilities and clarify the rights of the parties in the collaborative research relationship. We also present an example of a sponsored research agreement that we have designed as a model formal contract between sponsors and investigators. The most salient 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 trials research.