Ensuring good participant adherence in clinical trials plays an important role in that poor adherence may jeopardize the internal validity of the trial. Improving adherence in clinical trials on traditional Chinese medicine (TCM) has long been a concern for Chinese researchers who are conducting clinical trials. Drawing on from our past experiences in managing patient adherence in large-scale clinical trials, we identified factors that influence adherence and categorized them by sources into factors with respect to the trial protocol, on the part of the patients and the investigators. On this basis, we developed a series of ways to improve participants’ adherence, while taking into account the characteristics of TCM trials, in the hope of providing reference for peer clinical researchers. 1. Introduction Participants’ adherence can be defined to describe the implementation of prescribed medical orders in clinical trials. It refers to the subjects’ acceptance of prescribed treatment which contained the dosages and courses and followup. Adherence is closely related to the quality of clinical trials; low patient adherence with prescribed treatments is a very common problem in clinical trials and can seriously distort the generalizability and validity of controlled clinical trials [1]. A research showed that different adherence can lead to difference of end events significantly [2]. In addition, it can also save funding and reduce cycle time when improving the adherence in clinical trials. The adherence in clinical trials had been drawing more and more attentions of researchers abroad in the 1990s, and “The Journal of Compliance in Health Care” pays special attention to it. The phenomenon of non adherence is widespread among clinical trials [1, 3]. A study involved 1367 participants with hypertension showed that there are only 15.9% high adherers [4]. Some patients take medicine by an act of volition, and in double-blind, placebo-controlled trials, the code that was broken can lead to poor adherence also [5]. Poor adherence includes two aspects: one is adherence of drug therapy; that is, the patients fail to take drug in accordance with the prescribed methods of taking medicine, or accept the forbidden treatment, another one is adherence with followup; that is, patients do not follow up or get check on schedule or drop out without any reason during the trial. For the particularity of TCM clinical trials, there are some characteristic in patients adherence; part of the western medicine doctors mistrust the curative effect of TCM; their negative attitudes
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