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Patient managed clinical trial

T Hokkanen1, E Hemminki, P Aalto

  • 1Tampere School of Public Health, Finland.

Controlled Clinical Trials
|April 1, 1997
PubMed
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This study explored a novel postmenopausal hormone therapy trial design. Recruitment was successful, but patient compliance with hormone therapy was poor due to randomization aversion and physician attitudes.

Area of Science:

  • Clinical Trials
  • Women's Health
  • Pharmacology

Background:

  • Postmenopausal hormone therapy (HT) is common.
  • Traditional trial designs may not reflect real-world healthcare practices.
  • There is a need for trial designs that incorporate patient management and placebo effects.

Purpose of the Study:

  • To design and evaluate a novel clinical trial for postmenopausal hormone therapy.
  • To incorporate patient management, placebo effects, and align with ordinary healthcare services.
  • To assess the feasibility and identify challenges in such a trial design.

Main Methods:

  • A randomized recommendation to use or not use hormone therapy was given.
  • Participants were invited to discussion groups and completed questionnaires.

Related Experiment Videos

  • Participants were instructed to consult their own physicians and self-fund the therapy.

    • Main Results:

    • The trial design demonstrated success in patient recruitment.
    • Compliance with hormone therapy after six months was unsatisfactory.
    • Key challenges included patient aversion to randomization, physician attitudes, and difficulty discontinuing therapy.

    Conclusions:

    • While recruitment was effective, the trial design faced significant compliance issues.
    • Patient and physician factors, along with therapy adherence, pose challenges to innovative trial designs.
    • Improving compliance may necessitate modifications leaning towards traditional trial structures unless societal perceptions of research evolve.