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Clinical trials design: structure modifying agents for osteoarthritis. Future guidelines: areas for development

N Bellamy1

  • 1Centre of National Research on Disability and Rehabilitation Medicine (CONRAD), University of Queensland, Brisbane, Australia.

Osteoarthritis and Cartilage
|July 27, 1999
PubMed

Insights

Recent OsteoArthritis Research Society International (OARSI) guidelines offer expert recommendations for Structure Modifying Osteoarthritis Drugs (STMOAD) trials. Continued development in trial design is needed, but current methods can identify STMOAD agents.

Area of Science:

  • Rheumatology and Clinical Trial Design

Background:

  • Clinical trial guidelines require evidence-based recommendations and expert opinions.
  • Recent OsteoArthritis Research Society International (OARSI) guidelines were developed by a multidisciplinary Task Force.

Purpose of the Study:

  • To outline key areas for continued development in clinical trials for Structure Modifying Osteoarthritis Drugs (STMOAD).
  • To affirm the utility of current methodologies for identifying STMOAD agents.

Main Methods:

  • The study is based on the principles guiding the development of recent OARSI guidelines.
  • It reflects a Task Force Workshop involving academia, regulatory authorities, and industry.

Main Results:

  • Specific areas for improvement in STMOAD trials include patient selection, study duration, sample size, outcome assessment, imaging, response definition, and pharmoeconomics.
  • Despite areas needing development, current methodologies offer opportunities to identify STMOAD class agents.

Conclusions:

  • Guideline documents for STMOAD trials necessitate regular revision to incorporate evolving developments.
  • Current methodologies provide a viable pathway for identifying STMOAD agents, despite ongoing refinement needs in trial design.

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