Specific compliance issues in an antiestrogen trial of women at risk for breast cancer

Compliance is of enormous consequence to the study aims and to the reliability of results that emerge from a long-term antiestrogen chemoprevention trial. It is important that such a trial utilize a committed population who receive adequate study materials to inform them of the aims of the trial and to motivate continued compliance. A run-in period on a placebo should precede actual randomization. A simple dosing schedule of once per day, or at the most twice per day, is essential for program success. Subjects need to be contacted frequently and may need an incentive to comply. The assessment of compliance requires careful monitoring and follow-up of subjects on scheduled visits and completion of scheduled questionnaires. Medication use self-report and pill counts should be used and the collection of periodic blood follicle-stimulating hormone samples should be a part of the study although only a small sample of this sera plasma actually will be utilized for determining compliance. These compliance-enhancing strategies can help to ensure the integrity of this important trial.