• 1. Center for Clinical Epidemiology and Methodology (CCEM), Guangdong Second Provincial General Hospital, Guangzhou 510317, P.R.China;
  • 2. Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences & 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, P.R.China;
  • 3. Department of Clinical Epidemiology and Biostatistics, Beijing University of Chinese Medicine, Beijing 100029, P.R.China;
  • 4. School of Public Health, Lanzhou University, Lanzhou 730000, P.R.China;
  • 5. Key Laboratory of Chinese Internal Medicine of Ministry of Education, Beijing University of Chinese Medicine, Beijing 100700, P.R.China;
LI Guowei, Email: ligw@gd2h.org.cn
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In medical research, pilot and feasibility studies are conducted to reduce the uncertainty of future main trial and enhance its overall quality and probability of successful completion. The objective of a pilot and feasibility study is to answer whether the main trial can be performed, should be performed, and if so, how. Due to the tremendous resources, time, and funding required for a phase Ⅲ clinical trial, conducting a pilot and feasibility study is generally a pivotal step. While pilot and feasibility studies are gaining increasing attention in clinical research, efforts are largely required to promote the dissemination in China. Therefore, in this article, we briefly introduce the concepts of a pilot and feasibility study, its importance to the main trial, and current practice. Examples are also provided to help illustrate the introduction.

Citation: LI Guowei, WU Darong, ZHANG Ying, ZHANG Jingyi, LI Ziyi, SHANG Hongcai. Introduction to pilot and feasibility studies in medical research. Chinese Journal of Evidence-Based Medicine, 2021, 21(5): 617-620. doi: 10.7507/1672-2531.202011065 Copy

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