A strategy for collecting pharmacoeconomic data during phase II/III clinical trials.


Journal Article

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.

Full Text

Cited Authors

  • Mauskopf, J; Schulman, K; Bell, L; Glick, H

Published Date

  • March 1996

Published In

Volume / Issue

  • 9 / 3

Start / End Page

  • 264 - 277

PubMed ID

  • 10160101

Pubmed Central ID

  • 10160101

Electronic International Standard Serial Number (EISSN)

  • 1179-2027

International Standard Serial Number (ISSN)

  • 1170-7690

Digital Object Identifier (DOI)

  • 10.2165/00019053-199609030-00007


  • eng