A System for Handling Unsolicited Postmarketing Study Proposals

Abstract

Pharmaceutical companies frequently receive unsolicited study proposals from a variety of individuals interested in conducting postmarketing studies with their products. A system for handling and funding these proposals has been developed by the Regional Research (RR) Group in the Department of Medical Development-Marketed Products at Glaxo Inc. This group facilitates the processing, review, and follow-up of these proposals. Following committee review, approved studies are supported financially and monitored by the RR Group. The primary purposes for funding these studies are to: 1) support marketed products through publications and presentations; 2) support efforts of sales representatives by providing them with a resource for responding to individuals interested in conducting clinical studies; and 3) encourage development of scientific data that may not conform to established clinical programs. By providing this support, RR makes available a mechanism to sponsor studies not planned by the clinical and marketing groups, but considered interesting and informative. Product visibility and public relations with the medical community are also enhanced through the support and successful completion of these studies.