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GAP: From Sound Design to Practical Implementation in Clinical Trials for Traditional Chinese Medicine

Call for Papers

Research design, implementation, and process evaluation are steps of critical importance for clinical studies with traditional Chinese medicine (TCM).The years following 1980s witnessed the introduction of clinical epidemiology, evidence-based medicine (EBM), and good clinical practice (GCP) into domestic academia, and since then there has been a growing acceptance and application of the concepts, models, and tools developed in the above areas in clinical studies for TCM. A number of scholars believed that the use of scientific methodology can improve the rigor of clinical studies in the area of TCM and therefore devoted themselves to promoting it in practice. Randomized controlled trials (RCTs), cohort studies, and case-control studies have greatly increased in clinical research with TCM, and instead of favoring RCTs they had a rationale to justify their choice of a particular study design. However, having a sound design is just the first step towards research success. How to overcome obstacles to practical implementation of clinical trials posed another major challenge to trial managers and investigators. A widening gap has been observed between the methodologists’ preference for an “innovative” yet impracticable design and the researchers’ emphasis on needs and real circumstances of the patients and clinical practice. This led to departures from requirements stipulated in the study protocol and endangered the success of many clinical studies. In view of this, we have planned a special issue that can provide guidance on bridging the gap.

We invite investigators to contribute original research articles as well as review articles that focus on sound design and practical implementation in clinical studies with TCM. The information obtained from these studies shall be clearly evidence-based. Potential topics include, but are not limited to:

  • The practicability of study designs in clinical research of TCM
  • The need for unblinded clinicians to administer certain treatments
  • Comparisons between different types of therapies, for example, acupuncture against a medication
  • Factors influencing quality control in clinical research of TCM
  • Compliance control in clinical research of TCM
  • Methodology for process assessment in clinical research of TCM
  • Global lessons on keeping the balance between a scientific design and practicability in implementation
  • Experiences with and lessons learned from past clinical studies with TCM

Before submission authors should carefully read over the journal’s Author Guidelines, which are located at Prospective authors should submit an electronic copy of their complete manuscript through the journal Manuscript Tracking System at according to the following timetable:

Manuscript DueFriday, 2 August 2013
First Round of ReviewsFriday, 25 October 2013
Publication DateFriday, 20 December 2013

Lead Guest Editor

Guest Editors

  • Boli Zhang, China Academy of Chinese Medical Sciences, Beijing, China
  • Zhaoxiang Bian, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong
  • Nicola Robinson, University of Southbank, London, UK
  • Mike Clarke, All Ireland Hub for Trials Methodology Research, UK
  • Li Youping, Chinese Cochrane Centre, Chinese Evidence-Based Medicine Centre, Chengdu, China