การออกแบบการวิจัยเชิงทดลองเพื่อเปรียบเทียบประสิทธิผลในรูปแบบความเหนือกว่า (Superiority), ความเท่าเทียม (Equivalence) และความไม่ด้อยกว่า (Non-inferiority)

Khemajira Karaketklang

Authors

Khemajira Karaketklang Department of Medicine Faculty of Siriraj Hospital, Mahidol University

Keywords:

Superiority, Equivalence, Non-Inferiority, Confidence Interval of the Difference

Abstract

In experimental research, particularly within the medical field, it is crucial to compare novel interventions with existing standards of care to evaluate their relative efficacy. Generally, experimental designs are categorized into four common types based on the specific research question: difference, superiority, equivalence, and non-inferiority trials. A profound understanding of these designs is essential for the accurate interpretation of clinical outcomes. This ensures that the most effective treatments are identified and appropriately administered to patients, thereby maximizing clinical benefits while minimizing errors in medical practice.

References

วรรณดี พลานุภาพ, ศิริชัย ธรรมชาติอารี, & พิมพ์นราพร พู่ทองคำ. (2556). ประสิทธิผลในการปรับแต่งสันเหงือกส่วนหน้าของเพดานเทียม 2 ชนิด ในการรักษาทารกปากแหว่งเพดานโหว่ด้านเดียวแบบสมบูรณ์. วิทยาสารทันตแพทยศาสตร์, 63(4), 156-164.

อรุณ จิรวัฒน์กุล. (2550). ชีวสถิติ (พิมพ์ครั้งที่ 4). ขอนแก่น: ภาควิชาชีวสถิติและประชากรศาสตร์ คณะสาธารณสุขศาสตร์ มหาวิทยาลัยขอนแก่น.

Chow, S. C., Shao, J., & Wang, H. (2003). Sample size calculations in clinical research. New York: Marcel Dekker.

Cohen, C. J., Andrade-Villanueva J., Clotet, B., Fourie, J., Johnson, M. A., Ruxrungtham, K., et al. (2011). Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): A phase 3, randomized, non-inferiority trial. Lancet, 378(9787), 229-237.

Committee for proprietary medicinal products (CPMP). (2000). Points to consider on switching between superiority and non-inferiority. Retrieved April 20, 2025, https://www.tga.gov.au/sites/default/files/2024-12/enswitching_between_superiority_and_non-inferiority.pdf

Committee for Proprietary Medicinal Products. (2001). Points to consider on switching between superiority and non-inferiority. British Journal of Clinical Pharmacology, 52(3), 223-228.

Deere, K. C., Whitehouse, M. R., Porter, M., Blom, A. W., & Sayers, A. (2016). Assessing the non-inferiority of prosthesis constructs used in hip replacement using data from the National Joint Registry of England, Wales, Northern Ireland and the Isle of Man: A benchmarking study. BMJ Open, 9(4), e026685.

Graudins, A., Meek, R., Parkinson, J., Egerton-Warburton, D., & Meyer, A. (2016). A randomized controlled trial of paracetamol and ibuprofen with or without codeine or oxycodone as initial analgesia for adults with moderate pain from limb injury. Emergency Medicine Australasia, 28(6), 666-672.

Padullés, A., Colom, H., Bestard, O., Melilli, E., Sabé, N., Rigo, R., et al. (2016). Contribution of population pharmacokinetics to dose optimization of ganciclovir-valganciclovir in solid-organ transplant patients. Antimicrobial Agents and Chemotherapy, 60(4), 1992-2002.

Piaggio, G., Elbourne, D. R., Pocock, S. J., Evans S. J. W., & Altman, D. G. (2012). Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA, 308(24), 2594–2604.

Sayers, A., Crowther, M. J., Judge, A., Whitehouse, M. R., & Blom, A. W. (2017). Determining the sample size required to establish whether a medical device is non-inferior to an external benchmark. BMJ Open, 7(8), e015397.

Schumi, J., & Wittes, J. T. (2011). Through the looking glass: understanding non-inferiority. Trials, 12, 106.

Walker, E., & Nowacki, A. S. (2011). Understanding equivalence and noninferiority testing. Journal of General Internal Medicine, 26(2), 192–196.

Wang, X., & Ji, X. (2020). Sample size estimation in clinical research: From randomized controlled trials to observational studies. Chest, 158(1S), S12–S20.