Patient recruitment for clinical trials on traditional Chinese medicine: Challenges, barriers, and strategies

Abstract

Failure to recruit sufficient numbers of participants is a major barrier to the completion of randomized controlled trials in traditional Chinese medicine (TCM) clinical trials. The purpose of this paper is to analyze the commonly used strategies for the recruitment of patients in TCM clinical trials, to identify the most common reasons for attrition and refusal, and to identify barriers and potential solutions to the difficulties. There are four stages in the actual recruitment process, which included introducing the project to the potential patients, explaining how to implement the project, assessing and intensifying the understanding and facilitating patient decision-making. When insufficient recruitment occurred, the following steps should be considered: reevaluating the required sample size; adding new sites to the trial; eliminating hospitals that had poor recruiting records; extending the patient recruitment period, modifying the patient inclusion/exclusion criteria; and shifting placebo-controlled to active-controlled arrangements. Success in reaching target recruitment depended largely on being able to directly contact patients through posters, newspaper advertisements, television interviews, patient support groups, and physician referrals in hospitals. Suspicions against the placebo and unwillingness to stop taking other herbal supplements made recruitment more difficult, time-consuming, and costly. In a Chinese community, open advertising in the local newspaper may be particularly attractive.