Clinical research is a key factor in healthcare progress, as it contributes toward improving our knowledge on the prevention, etiology, and treatment of different conditions. Healthcare professionals and researchers should be familiar with this specific terminology and procedures of clinical research to understand and be able to evaluate clinical trial results and make decisions using up-to-date recommendations. To do so, they must be familiar with different methodological aspects: from establishing the type of design, the study population, and the groups to be studied, to understanding the randomization and blinding processes. Additionally, when it comes to communicating the results and publishing them, it is also necessary to know how to do it adequately to ensure transparency. This work includes a description of different concepts commonly used in clinical research, particularly in the clinical trials field, in an attempt to compile different topics by providing a brief and accessible overview.
KianiAKNaureenZPhebyD, et al. Methodology for clinical research. J Prev Med Hyg2022; 63(2Suppl 3): E267–E278.
8.
FarrugiaPPetrisorBAFarrokhyarF, et al. Practical tips for surgical research: research questions, hypotheses and objectives. Can J Surg2010; 53(4): 278–281.
9.
NairB. Clinical trial designs. Indian Dermatol Online J2019; 10(2): 193–201.
BankheadCRichardsSHPetersTJ, et al. Improving attendance for breast screening among recent non-attenders: a randomised controlled trial of two interventions in primary care. J Med Screen2001; 8(2): 99–105.
14.
PatinoCMFerreiraJC. Inclusion and exclusion criteria in research studies: definitions and why they matter. J Bras Pneumol2018; 44(2): 84.
15.
U.S. Food and Drug Administration. Public workshop: evaluating inclusion and exclusion criteria in clinical trials. Workshop report. Washington, DC: The National Press Club, https://www.fda.gov/media/134754/download (2018, accessed 2 May 2024).
SilAKumarPKumarR, et al. Selection of control, randomization, blinding, and allocation concealment. Indian Dermatol Online J2019; 10(5): 601–605.
18.
KangMRaganBGParkJH. Issues in outcomes research: an overview of randomization techniques for clinical trials. J Athl Train2008; 43(2): 215–221.
19.
KinserPARobinsJL. Control group design: enhancing rigor in research of mind-body therapies for depression. Evid Based Complement Alternat Med2013; 2013: 140467.
MonaghanTFAgudeloCWRahmanSN, et al. Blinding in clinical trials: seeing the big picture. Medicina (Kaunas)2021; 57(7): 647.
22.
SchulzKFGrimesDA. Blinding in randomised trials: hiding who got what. Lancet2002; 359(9307): 696–700.
23.
HróbjartssonAEmanuelssonFSkou ThomsenAS, et al. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies. Int J Epidemiol2014; 43(4): 1272–1283.
24.
DaySJAltmanDG. Statistics notes: blinding in clinical trials and other studies. BMJ2000; 321(7259): 504.
GuptaKKAttriJPSinghA, et al. Basic concepts for sample size calculation: Critical step for any clinical trials!Saudi J Anaesth2016; 10(3): 328–331.
27.
GuptaSK. Intention-to-treat concept: a review. Perspect Clin Res2011; 2(3): 109–112.
28.
McCoyCE. Understanding the intention-to-treat principle in randomized controlled trials. West J Emerg Med2017; 18(6): 1075–1078.
29.
RanganathanPPrameshCSAggarwalR. Common pitfalls in statistical analysis: intention-to-treat versus per-protocol analysis. Perspect Clin Res2016; 7(3): 144–146.
30.
ShahPB. Intention-to-treat and per-protocol analysis. CMAJ2011; 183(6): 696.
31.
DwivediAKShuklaR. Evidence-based statistical analysis and methods in biomedical research (SAMBR) checklists according to design features. Cancer Rep (Hoboken)2020; 3(4): e1211.
LaiYChuXDiL, et al. Recent advances in the translation of drug metabolism and pharmacokinetics science for drug discovery and development. Acta Pharm Sin B2022; 12(6): 2751–2777.
36.
GrossASHarryACCliftonCS, et al. Clinical trial diversity: an opportunity for improved insight into the determinants of variability in drug response. Br J Clin Pharmacol2022; 88(6): 2700–2717.
37.
LiYMengQYangM, et al. Current trends in drug metabolism and pharmacokinetics. Acta Pharm Sin B2019; 9(6): 1113–1144.
SchulzKFAltmanDGMoherD; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ2010; 340: c332.
42.
MoherDHopewellSSchulzKF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ2010; 340: c869.
43.
MoherDSchulzKFAltmanD; CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA2001; 285(15): 1987–1991.
National Research Council (US) Panel on Handling Missing Data in Clinical Trials. The prevention and treatment of missing data in clinical trials. Washington, DC: National Academies Press (US), 2010. Appendix A, Clinical trials: overview and terminology, https://www.ncbi.nlm.nih.gov/books/NBK209903/
49.
DwivediAK. How to write statistical analysis section in medical research. J Investig Med2022; 70(8): 1759–1770.
