Introduction to pilot and feasibility studies in medical research_Chinese Journal of Evidence-Based Medicine

Authors：

 LI Guowei ¹ , WU Darong ² , ZHANG Ying ³ , ZHANG Jingyi ⁴ , LI Ziyi ¹ , SHANG Hongcai ⁵

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;

Corresponding author：

LI Guowei, Email: ligw@gd2h.org.cn

Keywords：

Pilot and feasibility study; Randomized controlled trial; Phase Ⅲ clinical trial

DOI：

10.7507/1672-2531.202011065

Video：

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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

1.	Eldridge SM, Lancaster GA, Campbell MJ, et al. Defining feasibility and pilot studies in preparation for randomised controlled trials: development of a conceptual framework. PloS One, 2016, 11(3): e0150205.
2.	Lancaster GA. Pilot and feasibility studies come of age! Pilot Feasibility Stud, 2015, 1: 1.
3.	Eldridge SM, Chan CL, Campbell MJ, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ, 2016, 355: i5239.
4.	Story DA, Leslie K, French C. Feasibility and pilot studies: small steps before giant leaps. Anaesth Intensive Care, 2018, 46(1): 11-12.
5.	Avery KN, Williamson PR, Gamble C, et al. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open, 2017, 7(2): e013537.
6.	Craig P, Dieppe P, Macintyre S, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud, 2013, 50(5): 587-592.
7.	BMC. Pilot and feasibility studies. Available at: https://pilotfeasibilitystudies.biomedcentral.com/.
8.	Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract, 2004, 10(2): 307-312.
9.	Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol, 2010, 10(1): 1.
10.	In J. Introduction of a pilot study. Korean J Anesthesiol, 2017, 70(6): 601-605.
11.	Lièvre M, Ménard J, Bruckert E, et al. Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. BMJ, 2001, 322(7286): 603-605.
12.	Boyd K. Commentary: Early discontinuation violates Helsinki principles. BMJ, 2001, 322(7286): 605-606.
13.	Hip Fracture Accelerated Surgical Treatment and Care Track (HIP ATTACK) Investigators. Accelerated care versus standard care among patients with hip fracture: the HIP ATTACK pilot trial. CMAJ, 2014, 186(1): E52-60.
14.	Arain M, Campbell MJ, Cooper CL, et al. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol, 2010, 10: 67.
15.	Li G, Wu D, Chen X, et al. Pilot and feasibility trials in traditional Chinese medicine: a literature review of current practice. Pilot Feasibility Stud, 2020, 6: 48.
16.	张颖, 王俊慧, 胡烨胤, 等. 中医药临床研究中预试验样本量的确定. 中医杂志, 2021, 62(4): 307-311.

1. Eldridge SM, Lancaster GA, Campbell MJ, et al. Defining feasibility and pilot studies in preparation for randomised controlled trials: development of a conceptual framework. PloS One, 2016, 11(3): e0150205.
2. Lancaster GA. Pilot and feasibility studies come of age! Pilot Feasibility Stud, 2015, 1: 1.
3. Eldridge SM, Chan CL, Campbell MJ, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ, 2016, 355: i5239.
4. Story DA, Leslie K, French C. Feasibility and pilot studies: small steps before giant leaps. Anaesth Intensive Care, 2018, 46(1): 11-12.
5. Avery KN, Williamson PR, Gamble C, et al. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open, 2017, 7(2): e013537.
6. Craig P, Dieppe P, Macintyre S, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud, 2013, 50(5): 587-592.
7. BMC. Pilot and feasibility studies. Available at: https://pilotfeasibilitystudies.biomedcentral.com/.
8. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract, 2004, 10(2): 307-312.
9. Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol, 2010, 10(1): 1.
10. In J. Introduction of a pilot study. Korean J Anesthesiol, 2017, 70(6): 601-605.
11. Lièvre M, Ménard J, Bruckert E, et al. Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. BMJ, 2001, 322(7286): 603-605.
12. Boyd K. Commentary: Early discontinuation violates Helsinki principles. BMJ, 2001, 322(7286): 605-606.
13. Hip Fracture Accelerated Surgical Treatment and Care Track (HIP ATTACK) Investigators. Accelerated care versus standard care among patients with hip fracture: the HIP ATTACK pilot trial. CMAJ, 2014, 186(1): E52-60.
14. Arain M, Campbell MJ, Cooper CL, et al. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol, 2010, 10: 67.
15. Li G, Wu D, Chen X, et al. Pilot and feasibility trials in traditional Chinese medicine: a literature review of current practice. Pilot Feasibility Stud, 2020, 6: 48.
16. 张颖, 王俊慧, 胡烨胤, 等. 中医药临床研究中预试验样本量的确定. 中医杂志, 2021, 62(4): 307-311.

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