PharmacoEconomics

, Volume 9, Issue 3, pp 264–277 | Cite as

A Strategy for Collecting Pharmacoeconomic Data During Phase II/III Clinical Trials

  • Josephine Mauskopf
  • Kevin Schulman
  • Larry Bell
  • Henry Glick
Special Article

Summary

This article presents an overview of the process and organisational aspects required to support the collection of pharmacoeconomic (PE) data during phase II and phase III clinical trials of pharmaceutical products. The process described requires early involvement of the PE study team in clinical trials design and planning, as well as continuing close collaboration between the PE study team and the clinical study team as the data collection plans are implemented.

Adequate resources must be made available for staffing and funding the PE component of data collection and analysis. If the suggested procedures are adequately resourced and implemented, the result should be a comprehensive, complete and accurate database that will allow the PE study team to characterise the economic value of the new drug at the same time as the clinical study team characterise its safety and efficacy. Integrated clinical and economic evaluations are essential for the appropriate use of pharmaceutical products in rapidly changing markets.

Keywords

Adis International Limited Case Report Form Source Document Data Collection Effort Medical Bill 

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Copyright information

© Adis International Limited 1996

Authors and Affiliations

  • Josephine Mauskopf
    • 1
  • Kevin Schulman
    • 2
  • Larry Bell
    • 3
  • Henry Glick
    • 4
  1. 1.Glaxo Wellcome Inc.Research Triangle ParkUSA
  2. 2.Clinical Economics Research UnitGeorgetown University Medical CenterUSA
  3. 3.Independent health economics consultantRaleighUSA
  4. 4.Division of General Internal Medicine, and the Leonard Davis Institute of Health EconomicsUniversity of PennsylvaniaPhiladelphiaUSA

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