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Is recruitment more difficult with a placebo arm in randomised controlled trials? A quasirandomised, interview based
A J Welton1, M R Vickers, J A Cooper
1Medical Research Council Epidemiology and Medical Care Unit, Wolfson Institute of Preventive Medicine, St Bartholomew's and Royal London Hospital School of Medicine and Dentistry, London ECIM 6BQ. a.j.welton@mds.qmw.ac.uk
BMJ (Clinical Research Ed.)
|April 24, 1999
Summary
Including a placebo in clinical trials for hormone replacement therapy may decrease women's willingness to participate. Reluctance to take placebos was a key factor influencing decisions, impacting recruitment for preventive studies.
Area of Science:
- Clinical Trial Design
- Medical Ethics
- Women's Health Research
Background:
- Hormone replacement therapy (HRT) is a common treatment for menopausal symptoms.
- Clinical trials are essential for evaluating the efficacy and safety of HRT.
- Patient recruitment and retention are critical for successful clinical trial outcomes.
Purpose of the Study:
- To assess the impact of a placebo arm on women's willingness to participate in HRT clinical trials.
- To identify factors influencing patient recruitment in preventive trials.
Main Methods:
- Quasirandomised, interview-based study design.
- Involved 436 postmenopausal women aged 45-64 across 10 general practices.
- Assessed stated willingness to enter a trial and reasons for decisions.
Main Results:
- Women informed about a trial without a placebo were more willing to participate (39%) compared to those informed about a trial with a placebo (30%).
- Explicit reluctance to take placebos contributed to lower participation rates.
- Primary motivations for participation included altruism and personal benefit; reasons for non-participation included fear of side effects or unnecessary medication.
Conclusions:
- The inclusion of a placebo arm in preventive clinical trials may negatively affect patient recruitment.
- Trial designers should consider patient perceptions of placebos when planning recruitment strategies.