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PREDICTORS OF GI PATIENT PARTICIPATION IN CLINICAL TRIALS

M Stewart, A Stewart, D Leddin
Dalhousie University, Halifax, Nova Scotia

The validity of a clinical trial depends, in part, on recruitment of patients representative of the affected group. Failure to meet this requirement may lead to significant bias. The factors, which influence patients with GI diseases to participate in clincal trials, are not entirely understood. The purpose of this study was to investigate personal and study design factors, which may influence participation.
METHODS: Demographic data was collected and the participants were given the outline of a hypothetical Phase III trial. This included risks, benefits, and chance of receiving placebo, time commitment, and required testing. They were then asked to rate, on a 1-7 scale ranging from strongly discourages participation to strongly encourage participation, 14 factors which may influence a patient's decision to decline or agree to participate.
RESULTS: Three hundred and ten patients were enrolled, 222 agreed to participate in the hypothetical trial, 59 declined and 29 were undecided. Forty per cent were male, 60% over the age of 40, 30% lived in a rural area, 86% had received education to high school level or higher, 40% had a family income greater than $40,000, 20% had previously participated in a clinical trial, and 60% were married.
Participation in a trial was associated with younger age (p=0.002), higher family income (p=0.004), previous participation (p=0.01), and being employed (p=0.05). Access to free medication, quick access to medical care, contribution to new knowledge, confidence in the medical system, positive physician recommendation, limited other options for therapy, and the possibility of more effective treatment were ranked as encouragements to participate (score >5). The requirement for extra tests, media reports and proximity the research center were minimal positive inducements (score between 4-5). The chance of being randomized to placebo, the risk of adverse effects, risk of side effects and time commitment were mild discouragements (score between 3-4).
CONCLUSION: Participation in clincal trials by GI patients is influenced by a variety of personal and trial related factors. Trials designed with these in mind may encourage broader patient participation.

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