ABSTRACT

Research arrangements between pharmaceutical manufacturers and universities are commonplace, and a long history of mutual cooperation and understanding exists with regard to issues such as intellectual property rights, scientific independence and integrity, contractual issues, and academic freedom. In recent years, pharmaceutical manufacturers have expressed an interest in developing and validating health-related quality of life (HQL) instruments either in the randomized clinical trial (RCT) setting or in independent studies parallel to a RCT. This chapter discusses the reasons underlying a pharmaceutical manufacturer’s interest in funding HQL research within the context of medical, regulatory, and marketing uses of the research. The chapter also reviews some of the ethical issues surrounding industry-sponsored research. The issue of ethical conduct of industry-sponsored pharmacoeconomic research was raised by Hillman et al. (1991) and is addressed within the context of this discussion.