Kosin Med J.  2022 Sep;37(3):187-191. 10.7180/kmj.22.122.

How to conduct well-designed clinical research

Affiliations
  • 1Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea

Abstract

Clinicians and healthcare decision-makers conduct their clinical practice based on the results of clinical trials. However, some health problems remain unresolved; in such cases, further research is required. To ensure reliable research results, it is important to understand the study design and conduct well-designed clinical trials. Many study designs can be chosen within the two broad categories of observational and interventional. Clinical studies have a variety of designs, including case series, case-control, cross-sectional, and prospective and retrospective cohort studies. Well-designed clinical studies can clarify important differences between treatment options and provide data on long-term drug efficacy and safety. Interpreting the results of clinical trials can be difficult because weaknesses in research design, data collection methods, analytic methods, and reporting can compromise their value and usefulness. However, although randomized controlled trials are limited owing to ethical and practical issues, they are optimal for investigating the effects of therapy and establishing causality. Here we present an overview of different clinical research designs and review their advantages and limitations.

Keyword

Clinical research; Clinical study; Clinical trial; Research design

Cited by  2 articles

The effects of rebamipide, sucralfate, and rifaximin against inflammation and apoptosis in radiation-induced murine intestinal injury
Won Moon, Sangwook Lim, Yeonsoon Jung, Yuk Moon Heo, Seun Ja Park, Moo In Park, Sung Eun Kim, Jae Hyun Kim, Kyoungwon Jung
Kosin Med J. 2022;37(4):320-341.    doi: 10.7180/kmj.22.140.

Evaluation of automated calibration and quality control processes using the Aptio total laboratory automation system
Namhee Kim, Yein Kim, Jeongeun Park, Jungsoo Choi, Hyunyong Hwang
Kosin Med J. 2022;37(4):342-353.    doi: 10.7180/kmj.22.144.


Reference

References

1. Jager KJ, Stel VS, Wanner C, Zoccali C, Dekker FW. The valuable contribution of observational studies to nephrology. Kidney Int. 2007; 72:671–5.
2. Schultz A, Saville BR, Marsh JA, Snelling TL. An introduction to clinical trial design. Paediatr Respir Rev. 2019; 32:30–5.
3. Berry DA. Emerging innovations in clinical trial design. Clin Pharmacol Ther. 2016; 99:82–91.
4. Kaptchuk TJ. The double-blind, randomized, placebo-controlled trial: gold standard or golden calf? J Clin Epidemiol. 2001; 54:541–9.
5. Noordzij M, Dekker FW, Zoccali C, Jager KJ. Study designs in clinical research. Nephron Clin Pract. 2009; 113:c218–21.
6. Murad MH, Sultan S, Haffar S, Bazerbachi F. Methodological quality and synthesis of case series and case reports. BMJ Evid Based Med. 2018; 23:60–3.
7. Kesmodel US. Cross-sectional studies: what are they good for? Acta Obstet Gynecol Scand. 2018; 97:388–93.
8. Schulz KF, Grimes DA. Case-control studies: research in reverse. Lancet. 2002; 359:431–4.
9. Wang X, Kattan MW. Cohort studies: design, analysis, and reporting. Chest. 2020; 158(1S):S72–8.
10. Pastorino R, De Vito C, Migliara G, Glocker K, Binenbaum I, Ricciardi W, et al. Benefits and challenges of Big Data in healthcare: an overview of the European initiatives. Eur J Public Health. 2019; 29(Suppl 3):23–7.
11. Yang J, Li Y, Liu Q, Li L, Feng A, Wang T, et al. Brief introduction of medical database and data mining technology in big data era. J Evid Based Med. 2020; 13:57–69.
12. Austin C, Kusumoto F. The application of big data in medicine: current implications and future directions. J Interv Card Electrophysiol. 2016; 47:51–9.
13. Bamberger M, Moore N, Lechat P; Participants of Round Table N° 3 of Giens XXVI. How to improve the clinical development paradigm and its division into phases I, II and III. Therapie. 2011; 66:331–4.
14. Tripepi G, Jager KJ, Dekker FW, Wanner C, Zoccali C. Bias in clinical research. Kidney Int. 2008; 73:148–53.
15. Manton KJ, Gauld CS, White KM, Griffin PM, Elliott SL. Qualitative study investigating the underlying motivations of healthy participants in phase I clinical trials. BMJ Open. 2019; 9:e024224.
16. Thall PF. A review of phase 2-3 clinical trial designs. Lifetime Data Anal. 2008; 14:37–53.
17. Bhide A, Shah PS, Acharya G. A simplified guide to randomized controlled trials. Acta Obstet Gynecol Scand. 2018; 97:380–7.
18. Green JA. Clinical trials in cancer. Br J Cancer. 2011; 104:1521–2.
19. Cesana BM, Biganzoli EM. Phase IV studies: some insights, clarifications, and issues. Curr Clin Pharmacol. 2018; 13:14–20.
20. Shen J, Swift B, Mamelok R, Pine S, Sinclair J, Attar M. Design and conduct considerations for first-in-human trials. Clin Transl Sci. 2019; 12:6–19.
Full Text Links
  • KMJ
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2024 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr