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CC BY-NC-ND 4.0 · Indian J Radiol Imaging 2025; 35(S 01): S119-S127
DOI: 10.1055/s-0044-1792044
Research and Publications: Contemporary and Beyond
Review Article

Comprehensive Guide to Randomized Controlled Trials in Radiology: Everything You Need to Know

Shreya Shukla 
1   Department of Radiodiagnosis, Mahamana Pandit Madanmohan Malaviya Cancer Centre & Homi Bhabha Cancer Hospital, Tata Memorial Hospital, Varanasi, Uttar Pradesh, India
2   Department of Radiology, Homi Bhabha National Institute, Mumbai, Maharashtra, India
,
Abhishek Mahajan 
3   Department of Imaging, The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, United Kingdom
4   Faculty of Health and Life Sciences, University of Liverpool, Liverpool, United Kingdom
› Institutsangaben Funding None.
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Abstract

Evidence-based medicine integrates clinical research, personal expertise, and patient values. The most robust forms of clinical evidence, such as randomized controlled trials (RCTs) and prospective studies, provide the strongest support for medical decision-making. RCTs are vital in radiology for evaluating new imaging technologies, contrast agents, and therapeutic procedures, despite challenges in translating preclinical findings to clinical practice. This guide discusses the history, principles, methodologies, and applications of RCTs in radiology, highlighting their role in advancing the field and supporting evidence-based practice.

Keywords

EBM - evidence-based medicine - precision medicine - radiology - randomized controlled trials - RCT


Publikationsverlauf

Artikel online veröffentlicht:
09. Januar 2025

© 2025. Indian Radiological Association. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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  • References

  • 1 Greenhalgh T, Donald A. Evidence Based Health Care Workbook: Understanding Research: For Individual and Group Learning. BMJ Publishing Group; 2000
    Suche in Google Scholar
  • 2 Force CT. The periodic health examination. Can Med Assoc J 1979; 121: 1193-1254
    PubMedSuche in Google Scholar
  • 3 Sackett DL. Rules of evidence and clinical recommendations on the use of antithrombotic agents. Chest 1989; 95 (02) 2S-4S
    CrossrefPubMedSuche in Google Scholar
  • 4 Cochrane Library Web site. Accessed September 10, 2004, at: www.update-software.com/abstracts/ab001877.htm
  • 5 Mahajan A, Goh V, Basu S. et al. Bench to bedside molecular functional imaging in translational cancer medicine: to image or to imagine?. Clin Radiol 2015; 70 (10) 1060-1082
    CrossrefPubMedSuche in Google Scholar
  • 6 Vaidya T, Agrawal A, Mahajan S, Thakur MH, Mahajan A. The continuing evolution of molecular functional imaging in clinical oncology: the road to precision medicine and radiogenomics (part I). Mol Diagn Ther 2019; 23 (01) 1-26
    CrossrefPubMedSuche in Google Scholar
  • 7 Vaidya T, Agrawal A, Mahajan S, Thakur MH, Mahajan A. The continuing evolution of molecular functional imaging in clinical oncology: the road to precision medicine and radiogenomics (part II). Mol Diagn Ther 2019; 23 (01) 27-51 Erratum in: Mol Diagn Ther 2019;23(1):151
    CrossrefPubMedSuche in Google Scholar
  • 8 Chidambaram AG, Josephson M. Clinical research study designs: the essentials. Pediatr Investig 2019; 3 (04) 245-252
    CrossrefPubMedSuche in Google Scholar
  • 9 Lim HJ, Hoffmann RG. Study design: the basics. Methods Mol Bio; 2007; 404: 1-17
    CrossrefPubMedSuche in Google Scholar
  • 10 Dennison DK. Components of a randomized clinical trial. J Periodontal Res 1997; 32 (05) 430-438
    CrossrefPubMedSuche in Google Scholar
  • 11 Hill AB. The clinical trial. N Engl J Med 1952; 247 (04) 113-119
    CrossrefPubMedSuche in Google Scholar
  • 12 Jadad AR. Randomised controlled trials: a user's guide. Health Technol Assess 1998; 2 (13) 214
    Suche in Google Scholar
  • 13 Stolberg HO, Norman G, Trop I. Randomized controlled trials. AJR Am J Roentgenol 2004; 183 (06) 1539-1544
    CrossrefPubMedSuche in Google Scholar
  • 14 Louis TA, Lavori PW, Bailar III JC, Polansky M. Crossover and self-controlled designs in clinical research. In: Bailar III JC, Mosteller F. eds. Medical Uses of Statistics. 2nd ed. Boston, MA:: New England Medical Journal Publications;; 1992: 83-104
    Suche in Google Scholar
  • 15 Woods KL. Mega-trials and management of acute myocardial infarction. Lancet 1995; 346 (8975) 611-614
    CrossrefPubMedSuche in Google Scholar
  • 16 Altman DG. Practical Statistics for Medical Research. London, England:: Chapman & Hall;; 1991
    Suche in Google Scholar
  • 17 Charlton BG. Mega-trials: methodological issues and clinical implications. J R Coll Physicians Lond 1995; 29 (02) 96-100
    PubMedSuche in Google Scholar
  • 18 Begg C, Cho M, Eastwood S. et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996; 276 (08) 637-639
    CrossrefPubMedSuche in Google Scholar
  • 19 Chan KB, Man-Son-Hing M, Molnar FJ, Laupacis A. How well is the clinical importance of study results reported? An assessment of randomized controlled trials. CMAJ 2001; 165 (09) 1197-1202
    PubMedSuche in Google Scholar
  • 20 Alvin MD, Moshiri M, Bluemke DA. Prospective Clinical Trials: 10-year Trends in Radiology . Radiology 2020; 295 (01) 1-2
    CrossrefPubMedSuche in Google Scholar
  • 21 Dewey M, Bosserdt M, Dodd JD, Thun S, Kressel HY. Clinical imaging research: higher evidence, global collaboration, improved reporting, and data sharing are the grand challenges. Radiology 2019; 291 (03) 547-552
    CrossrefPubMedSuche in Google Scholar
  • 22 Park SH, Choi JI, Fournier L, Vasey B. Randomized clinical trials of artificial intelligence in medicine: why, when, and how?. Korean J Radiol 2022; 23 (12) 1119-1125
    CrossrefPubMedSuche in Google Scholar
  • 23 Mahajan A, Vaidya T, Gupta A, Rane S, Gupta S. Artificial intelligence in healthcare in developing nations: The beginning of a transformative journey. Cancer Res Stat Treat 2019; 2 (02) 182-189
    CrossrefSuche in Google Scholar
  • 24 Chakrabarty N, Mahajan A. Imaging analytics using artificial intelligence in oncology: a comprehensive review. Clin Oncol 2024; 36 (08) 498-513
    CrossrefPubMedSuche in Google Scholar
  • 25 Park SH, Han K. Methodologic guide for evaluating clinical performance and effect of artificial intelligence technology for medical diagnosis and prediction. Radiology 2018; 286 (03) 800-809
    CrossrefPubMedSuche in Google Scholar
  • 26 Lehman CD, Yala A, Schuster T. et al. Mammographic breast density assessment using deep learning: clinical implementation. Radiology 2019; 290 (01) 52-58
    CrossrefPubMedSuche in Google Scholar
  • 27 Aberle DR, Adams AM, Berg CD. et al; National Lung Screening Trial Research Team. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 2011; 365 (05) 395-409
    CrossrefPubMedSuche in Google Scholar
  • 28 Fontana RS, Sanderson DR, Woolner LB. et al. Screening for lung cancer. A critique of the Mayo Lung Project. Cancer 1991; 67 (04) 1155-1164
    CrossrefPubMedSuche in Google Scholar
  • 29 Hofvind S, Holen ÅS, Aase HS. et al. Two-view digital breast tomosynthesis versus digital mammography in a population-based breast cancer screening programme (To-Be): a randomised, controlled trial. Lancet Oncol 2019; 20 (06) 795-805
    CrossrefPubMedSuche in Google Scholar
  • 30 Berg WA. Rationale for a trial of screening breast ultrasound: American College of Radiology Imaging Network (ACRIN) 6666. AJR Am J Roentgenol 2003; 180 (05) 1225-1228
    CrossrefPubMedSuche in Google Scholar
  • 31 Szewczyk-Bieda M, Wei C, Coll K. et al. A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol. Trials 2019; 20 (01) 638
    CrossrefPubMedSuche in Google Scholar
  • 32 Izumi N, Hasegawa K, Nishioka Y. et al. A multicenter randomized controlled trial to evaluate the efficacy of surgery vs. radiofrequency ablation for small hepatocellular carcinoma (SURF trial). J Clin Oncol 2019; 39 (15) 4002-4002
    CrossrefSuche in Google Scholar
  • 33 Radosevic A, Quesada R, Serlavos C. et al. Microwave versus radiofrequency ablation for the treatment of liver malignancies: a randomized controlled phase 2 trial. Sci Rep 2022; 12 (01) 316
    CrossrefPubMedSuche in Google Scholar
  • 34 Zhang Y, Xi M, Chen M, Xu L, Liu S-L, Liu M. and Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center.. “A prospective, open-label, randomized, controlled trial of radiofrequency ablation versus stereotactic body radiation therapy for recurrent small hepatocellular carcinoma.”. J Clin Oncol 2023; 41 (06) 4096-4096
    CrossrefSuche in Google Scholar
  • 35 Facciorusso A, Abd El Aziz MA, Tartaglia N. et al. Microwave ablation versus radiofrequency ablation for treatment of hepatocellular carcinoma: a meta-analysis of randomized controlled trials. Cancers (Basel) 2020; 12 (12) 3796
    CrossrefPubMedSuche in Google Scholar
  • 36 Pinto I, Chimeno P, Romo A. et al. Uterine fibroids: uterine artery embolization versus abdominal hysterectomy for treatment–a prospective, randomized, and controlled clinical trial. Radiology 2003; 226 (02) 425-431
    CrossrefPubMedSuche in Google Scholar
  • 37 Lencioni RA, Allgaier HP, Cioni D. et al. Small hepatocellular carcinoma in cirrhosis: randomized comparison of radio-frequency thermal ablation versus percutaneous ethanol injection. Radiology 2003; 228 (01) 235-240
    CrossrefPubMedSuche in Google Scholar
  • 38 Mahajan A, Chand A, Agarwal U. et al. Prognostic value of radiological extranodal extension detected by computed tomography for predicting outcomes in patients with locally advanced head and neck squamous cell cancer treated with radical concurrent chemoradiotherapy. Front Oncol 2022; 12: 814895
    CrossrefPubMedSuche in Google Scholar
  • 39 Mahajan A, B G, Wadhwa S. et al. Deep learning based automated epidermal growth factor receptor and anaplastic lymphoma kinase status prediction of brain metastasis in non-small cell lung cancer. Explor Target Antitumor Ther 2023; 4 (04) 657-668
    CrossrefPubMedSuche in Google Scholar
  • 40 Mahajan A, Goyal D, Agarwal U. et al. Exploring the implications of modified advanced lung cancer inflammation index on outcomes in patients with advanced non-small cell lung cancer. Explor Target Antitumor Ther 2023; 4 (05) 896-911
    CrossrefPubMedSuche in Google Scholar
  • 41 Mahajan A, Unde H, Sable NP. et al. Response assessment of post-treatment head and neck cancers to determine further management using NI-RADS (Neck Imaging Reporting and Data System): a subgroup analysis of a randomized controlled trial. Front Oncol 2023; 13: 1200366
    CrossrefPubMedSuche in Google Scholar
  • 42 Mahajan A, Ahmed S, McAleer MF. et al. Post-operative stereotactic radiosurgery versus observation for completely resected brain metastases: a single-centre, randomised, controlled, phase 3 trial. Lancet Oncol 2017; 18 (08) 1040-1048
    CrossrefPubMedSuche in Google Scholar
  • 43 Smith-Bindman R, Chu P, Wang Y. et al. Comparison of the effectiveness of single-component and multicomponent interventions for reducing radiation doses in patients undergoing computed tomography: a randomized clinical trial. JAMA Intern Med 2020; 180 (05) 666-675
    CrossrefPubMedSuche in Google Scholar
  • 44 Yoshimura S, Sakai N, Yamagami H. et al. Endovascular therapy for acute stroke with a large ischemic region. N Engl J Med 2022; 386 (14) 1303-1313
    CrossrefPubMedSuche in Google Scholar
  • 45 Zaidat OO, Kasab SA, Sheth S. et al. TESLA trial: rationale, protocol, and design. Stroke Vasc Intervent Neurol 2023; 3 (04) e000787
    CrossrefSuche in Google Scholar
  • 46 Sarraj A, Hassan AE, Abraham MG. et al; SELECT2 Investigators. Trial of endovascular thrombectomy for large ischemic strokes. N Engl J Med 2023; 388 (14) 1259-1271
    CrossrefPubMedSuche in Google Scholar
  • 47 Wei C, Szewczyk-Bieda M, Bates AS. et al. Multicenter randomized trial assessing MRI and image-guided biopsy for suspected prostate cancer: The MULTIPROS study. Radiology 2023; 308 (01) e221428
    CrossrefPubMedSuche in Google Scholar
  • 48 Kasivisvanathan V, Rannikko AS, Borghi M. et al; PRECISION Study Group Collaborators. MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med 2018; 378 (19) 1767-1777
    CrossrefPubMedSuche in Google Scholar
  • 49 Freiman JA, Chalmers TC, Smith H, Kuebler RR. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 “negative” trials. N Engl J Med 1978; 299 (13) 690-694
    CrossrefPubMedSuche in Google Scholar
  • 50 Chalmers I. Applying overviews and meta-analysis at the bedside discussion. J Clin Epidemiol 1995; 48: 67-70
    CrossrefSuche in Google Scholar
  • 51 Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet 2002; 359 (9300) 57-61
    CrossrefPubMedSuche in Google Scholar
  • 52 Kelsey JL. Methods in Observational Epidemiology. Monographs in Epidemiology and Biostatistics; Oxford University Press, Inc.; New York, New York: 1996
    Suche in Google Scholar
  • 53 Schlesselman JJ. Case-Control Studies: Design, Conduct, Analysis. Oxford University Press; New York, New York: 1982
    Suche in Google Scholar
  • 54 Thornbury JR. Eugene W. Caldwell Lecture. Clinical efficacy of diagnostic imaging: love it or leave it. AJR Am J Roentgenol 1994; 162 (01) 1-8
    CrossrefPubMedSuche in Google Scholar
  • 55 Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959; 22 (04) 719-748
    PubMedSuche in Google Scholar
  • 56 Tremaine WJ, Carlson MR, Isaacs KL, Motil KJ, Robuck PR, Wurzelmann JI. Ethical issues, safety, and data integrity in clinical trials. Inflamm Bowel Dis 2005; 11 (Suppl. 01) S17-S21
    CrossrefPubMedSuche in Google Scholar
  • 57 World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013; 310 (20) 2191-2194
    CrossrefPubMedSuche in Google Scholar
  • 58 Blackmore CC. The challenge of clinical radiology research. AJR Am J Roentgenol 2001; 176 (02) 327-331
    CrossrefPubMedSuche in Google Scholar
  • 59 Beam C, Blackmore C, Karlik S, Reinhold C. Editors' introduction to the series. AJR Am J Roentgenol 2001; 176 (02) 323-325
    CrossrefPubMedSuche in Google Scholar
  • 60 Crewson PE, Applegate KE. Data collection in radiology research. AJR Am J Roentgenol 2001; 177 (04) 755-761
    CrossrefPubMedSuche in Google Scholar