The European Journal of Health Economics

, Volume 7, Issue 2, pp 129–136 | Cite as

Outcomes research collaborations between third-party payers, academia, and pharmaceutical manufacturers

What can we learn from clinical research?
  • Hans-Georg Eichler
  • Sheldon X. Kong
  • Jean-Pierre Grégoire
Original Papers

Abstract

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.

Keywords

Drug development collaboration Drug regulatory agencies Outcomes research Pharmaceutical manufacturers Third-party payment 

Notes

Conflict of interest:

No information supplied.

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Copyright information

© Springer Medizin Verlag 2006

Authors and Affiliations

  • Hans-Georg Eichler
    • 1
    • 4
  • Sheldon X. Kong
    • 2
  • Jean-Pierre Grégoire
    • 3
  1. 1.Department of Clinical PharmacologyMedical University of ViennaViennaAustria
  2. 2.Outcomes ResearchMerck & Co., Inc.Whitehouse StationUSA
  3. 3.Faculty of Pharmacy and Population Health Research UnitLaval UniversityQuebec CityCanada
  4. 4.Department of Clinical PharmacologyMedical University of Vienna, Allgemeines KrankenhausViennaAustria

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