Monitoring in clinical trials of complementary and alternative medicine

Abstract

Background Clinical trial monitoring is an essential activity for quality assurance (QA) to ensure the protection of human rights and the reliability and transparency of the data collection process. The purpose of this article is to enhance the understanding of monitoring process and major findings in clinical trials of complementary and alternative medicine (CAM). Methods Based on International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use (ICH-GCP), we summarized main concept of monitoring process. Personal experiences on monitoring for CAM studies were also narratively described. Results In this brief article, the basic concept of QA and quality control (QC), various monitoring activities during the study process, and major findings regarding clinical trials of CAM are suggested in an effort to improve understanding of monitoring in clinical research on CAM. Conclusion When performing clinical trials for CAM-related interventions, the monitoring recommended in GCP is needed to be recognized as a mandatory element in the course of CAM research.

Methodological issues in conducting yoga- and meditation-based research: A narrative review and research implications

“…For instance, if a given intervention is expected to affect the cognitive ability (e.g. multitasking) of the participants, then it is prudent to recruit participants for whom multitasking forms an important part of their work or life [ 18 , 38 ]. This criticism, however, stems from the belief that meditation may affect a specific cognitive ability.…”

“…), and the method adopted by them to ensure the fidelity of intervention delivery. These raise concerns about the methodological robustness of the research and also act as a roadblock in replicating the research findings [ 18 , 26 ].…”

“…and most importantly about the meditative practice under study (FA, OM, GM, ASD or mixed; kind of breathing; the level of exertion; modification of the practice based on age and culture of the participants, preparatory steps, etc.) [ 18 , 26 ]. It is also prudent to inform participants beforehand about the meditation-based intervention under study and its potential effect in a neutral yet specific manner.…”

“…However, the available research on the yoga and meditation-based interventions suffered from several methodological limitations: non-incorporation of the theoretical framework of the yoga/meditation practices while developing the interventions, lack of validated instruments to measure the practitioners’ experience, issue related to participant recruitment, and setting up effective control arm, concern over monitoring of meditation-based clinical trials, difficulty in assessing the role of various overt and covert factors on the outcome, etc. [ [14] , [15] , [16] , [17] , [18] ]. This has also been reflected in the ongoing research on the efficacy of yoga and meditation-based intervention for mental and physical consequences of COVID19 pandemic [ 19 ].…”

Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial

“…The research purpose, strategy, and procedures in clinical studies involving integrative medicine are frequently different from those in trials of pharmacological interventions conducted for the purpose of gaining regulatory approval to market a new drug entity [2]. Nonetheless, the protection of human participants, overseeing the research steps in the study plan, and confirming the accuracy of the data collected are equally important in clinical trials of integrative medicines as in drug and device studies [2].…”