Outcomes research collaborations between third-party payers, academia, and pharmaceutical manufacturers: What can we learn from clinical research?
Research collaborations between academic researchers, regulatory agencies, and pharmaceutical manufacturers have made the drug development process more efficient and have frequently supported the successful documentation of quality, safety, and efficacy of pharmaceuticals (the so-called three hurdles). Over recent years issues of drug cost, access, and utilization have moved to center stage, giving rise to a "fourth hurdle approval" process by third-party payers. This requires new forms of collaborative research among new players. This contribution highlights the need for a "triangular" relationship in the field of outcomes research between scientists in academia, third-party payer institutions, and pharmaceutical manufacturers. We discuss, and illustrate by case studies, how successful models of collaboration from the drug development process might be relevant to research activities related to the fourth hurdle. Case studies which may provide useful models for collaborative outcomes research include the "International Conference on Harmonization" process, the voluntary consultation procedures established by drug regulatory agencies, and the Quebec experience in database sharing.
Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria. hans-georg.eichler@meduniwien.ac.at
Hans-Georg
HG
Eichler
Sheldon X
SX
Kong
Jean-Pierre
JP
Grégoire
D035843:Biomedical Research / Q000458:organization & administration*; D003219:Confidentiality; D016265:Conflict of Interest; D016527:Drug Costs; D004345:Drug Industry; D004363:Drug Utilization; D006297:Health Services Accessibility / Q000458:organization & administration; D006801:Humans; D007256:Information Systems / Q000458:organization & administration; D007343:Insurance Carriers; D007373:Interinstitutional Relations; D015279:Organizational Culture; D017063:Outcome Assessment, Health Care / Q000458:organization & administration*; D014495:Universities / Q000458:organization & administration*