Randomized controlled trial: the gold standard or an unobtainable fallacy?

Bondemark, Lars; Ruf, Sabine

doi:10.1093/ejo/cjv046

Cited by 111Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsOrthodontics and Dentofacial Orthopedics

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Randomized controlled trial: the gold standard or an unobtainable fallacy?

Bondemark, Lars, Ruf, Sabine·2015·The European Journal of Orthodontics

DOI 10.1093/ejo/cjv046

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Abstract

BACKGROUND: This article is the result of a debate at the European Journal of Orthodontics Open Session in 2013 in Reykjavik, Iceland. OBJECTIVE: The aim of this article is to highlight some of the strengths and weakness of clinical orthodontic research, with particular emphasis on randomized controlled trials (RCT). The ultimate aim of improving clinical orthodontic research in general. DESIGN: This article is organized into two sections with arguments for and against RCTs. The backgrounds to evidence-based evaluation and the level or quality of evidence in trials are discussed. The article emphasises what makes high quality clinical research, and gives practical advice including examples of tips and potential pitfalls for those undertaking clinical research. RESULTS AND CONCLUSION: The overriding message is constructive and it is hoped that the article serves as an aid in evaluating, designing, conducting, and reporting clinical research.

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None of these studies were RCTs with a control group and random assignment, a design regarded as the gold standard, as RCTs are less susceptible to biases than studies with other designs for assessing therapeutic interventions.
“However, none of these studies were RCTs with a control group and random assignment, a design regarded as the gold standard, as RCTs are less susceptible to biases than studies with other designs for assessing therapeutic interventions”
From The feasibility and preliminary effects of a pilot randomized controlled trial: Videoconferencing acceptance and commitment therapy in distressed family caregivers of people with dementia. (2023) · cites this paper as Bondemark and Ruf, 2015

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Wang, Q., Guo, F., Liu, Y., Tao, Z., Zhao, T., HE, H., & Hua, F. (2026) · Journal of Evidence Based Dental Practice · doi:10.1016/j.jebdp.2026.102230 · Cited by 2
Review article: Electronic screening and brief intervention for alcohol‐related trauma: A systematic review and meta‐analysis
Woliansky, M., Lee, K. H., & Tadakamadla, S. K. (2024) · Emergency Medicine Australasia · doi:10.1111/1742-6723.14506 · Cited by 2
Historical milestones of the invention and use of placebo
Koterov, A. N. (2023) · FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology · doi:10.17749/2070-4909/farmakoekonomika.2022.118 · Cited by 2
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Alex, D., & Manang, F. (2022) · International Journal of Economy Education and Entrepreneurship (IJE3) · doi:10.53067/ije3.v2i3.94 · Cited by 2
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“…assessment tools found by the review studies is located in Supplementary File SB. Future studies looking to develop assessment tools in their work may turn their attention to the rigorous work provided by Algar et al. (2016), Bowling et al. (2015), Missotten et al. (2016), and Ready and Ott (2003).”
Method
Effects of scanning parameters reduction in dental radiographs on image quality and diagnostic performance: A randomised controlled trial
Ghazali, L., Yusof, M. Y. P. M., & Norman, N. (2020) · Journal of orthodontics · doi:10.1177/1465312520971641 · Cited by 2
“In an evidence-based approach to the evaluation of effectiveness, an RCT is considered to generate the highest level of evidence (Bondemark and Ruf, 2015).”
BackgroundMethodInfluential
How to succeed with high quality randomised clinical trials in clinical orthodontic research
Bondemark, L. (2019) · Journal of Orthodontics · doi:10.1177/1465312519842886 · Cited by 2
Self-citation
The Effects and Moderators of Online Evidence-Based Parenting Intervention When Delivered in Real-World Settings.
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Espejo-Mansilla, V., Coscia, A., Fuentes-Barría, H., Aguilera-Eguía, R. A., Angarita, L., Flores-Fernández, C., & Roco-Videla, Á. (2026) · Biomedicines · doi:10.3390/biomedicines14071565 · Cited by 1
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“В работе [31] отмечается, что не только чередование, алгоритм которого известен персоналу, но даже попытки рандомизации путем жребия – монетой или игральными костями, несет в себе риск подделки, поскольку может возникнуть искушение переделать процедуру так, чтобы она подходила к «нужному» пациенту.”
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Figer, B., Thaker, S. J., Boob, M., Gogtay, N., & Thatte, U. (2018) · Clinical Ethics · doi:10.1177/1477750918802428 · Cited by 1
“Randomized controlled trials (RCTs) are considered the gold standard among clinical study designs and have the potential to change clinical practice(3) and feature high on the evidence pyramid, just below systematic reviews and meta-analyses.(4) The New England”
Background
RCTs are here to stay.
Madsen, H. (2016) · European Journal of Orthodontics · doi:10.1093/ejo/cjw002 · Cited by 1
“Dear Sir, The article on randomized controlled trials (RCTs) I refer to originates from an invited debate at the EOS meeting in Reykjavik (1).”
Background
Epi-No should be tested in different obstetric settings until an evidence-based clinical decision can be made
Brito, L., Ferreira, C. H., & Marcolin, A. (2015) · International Urogynecology Journal · doi:10.1007/s00192-015-2857-8 · Cited by 1
“Using an idea that is generally believed to be true without testing it may be a fallacy [2].”
Background
A Randomized Double‐Blind Placebo‐Controlled Multicentric Clinical Trial of an Ayurvedic Intervention, Varadi Kwatha Ghana Vati, as an Adjunct vs Treatment as Usual in the Management of Type‐2 Diabetes Mellitus: A Study Protocol
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“On the other hand, RCTs stand as the gold standard in biomedical research with an unbiased approach to assessing the effectiveness of interventions (Bondemark & Ruf, 2015).”
Cardiovascular disease risk reduction interventions for Indigenous women: an umbrella review
Rahman, T., Bingham, A. L., Carrington, M. J., Chenhall, R., Eades, F., Joshy, G., Banks, E., & Eades, S. (2026) · Health Promotion International · doi:10.1093/heapro/daag051
“When conducted with rigour, RCTs are regarded as generating the highest standard evidence on the causal relationship between an intervention and its outcomes of interest (Bondemark and Ruf 2015, Grossman and Mackenzie 2005).”
Optimising on-treatment review schedules: A narrative review of acute toxicities in ultra-hypofractionated stereotactic ablative body radiotherapy (SABR) for localised prostate cancer.
McKenna, G., & Flood, T. (2026) · Radiography · doi:10.1016/j.radi.2026.103357
Cluster minimal sufficient balance (CMSB): an efficient covariate balancing randomization method for cluster randomized trials
Cai, J.-X., Suo, S.-S., Ndip, V., Khairallah, C., Zhang, B.-Y., Zeng, L.-X., Yan, H., Shao, F., Chen, T., & Li, C. (2026) · BMC Medical Research Methodology · doi:10.1186/s12874-025-02758-0
“Randomized controlled trials (RCTs) represent the gold standard for evaluating therapeutic interventions against standard care, placebo, or no treatment [1–3].”
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Anis, L., Benzies, K., Ewashen, C., Hart, M. J., & Letourneau, N. L. (2025) · Children · doi:10.3390/children12121605
“Finally, RCTs prohibit researchers from making mid-course adaptations based on their learning during different phases of RCTs [27,33].”
Correction for Weak IV Bias and Winner's Curse in Mendelian Randomization Egger Regression: Rerandomized Egger estimator
Su, Y., Ma, Y., Yin, P., & Wang, P. (2025) · arXiv (Cornell University) · doi:10.48550/arxiv.2507.09634
“Mendelian randomization (MR) uses genetic variants as natural instrumental variables (IVs) to strengthen causal inference from observational data by exploiting the random allocation of alleles at conception, thereby mimicking certain aspects of randomization.”
Using Vacuum Erection Devices for the Treatment of Erectile Dysfunction Following Radical Prostatectomy: A Review of the Literature
Skews, R., & Marley, J. (2025) · International Journal of Urological Nursing · doi:10.1111/ijun.70015
Randomized Control Trials of CBT to Manage the Mental Health Related Issues of Flood Victimized in Taunsa Sharif and Rajanpur City
Jamil, B., & Khan, A. A. (2025) · Social Science Review Archives · doi:10.70670/sra.v3i1.534
“The research design used in this study has been regarded as the gold standard for determining the effectiveness of interventions (Bondemark & Ruf, 2015).”
The Role of Adjuvant Metronomic Chemotherapy in Increasing Overall Response Rate in Patients with Breast Cancer
Bhushan, J., & Akhila, P. (2022) · International Journal of Cancer and Clinical Research · doi:10.23937/2378-3419/1410176
“To evaluate effectiveness, RCT is the acknowledged standard and is believed to produce the highest quality of evidence [6].”
Background
Anterior open bite correction: Do perceived impacts match normative outcomes?
Peter, E., Monisha, J., Baiju, R., & Suja, A. (2020) · American Journal of Orthodontics and Dentofacial Orthopedics · doi:10.1016/j.ajodo.2019.10.013
"Herding Cats".
van Dellen, J. V. (2018) · World Neurosurgery · doi:10.1016/j.wneu.2018.05.250
Predicting Class II functional treatment outcome.
Veginadu, P., & Padmanabhan, S. (2016) · European Journal of Orthodontics · doi:10.1093/ejo/cjw006
“Faculty of Odontology, Malmö University, Malmö, Sweden, Department of Orthodontics, University of Giessen, Giessen, Germany Dear Sir, It was with great interest we read the comment by Dr Madsen on our article ‘Randomized controlled trial: the gold standard or an unobtainable fallacy?’ published in the September 2015 i…”
BackgroundInfluential
Reply to Dr H. Madsen's Letter.
Bondemark, L., & Ruf, S. (2016) · European Journal of Orthodontics · doi:10.1093/ejo/cjw007
Self-citation
Application of Bio-Feedback in Neurodevelopmental Disorders
Venkatesan, S., & Venkataraman, H. (2019) · Emerging Trends in the Diagnosis and Intervention of Neurodevelopmental Disorders · doi:10.4018/978-1-5225-7004-2.ch011
Development of a Framework to Describe the Association Between Hypothetical and Real-World Decisions: A Systematic Concept Review and Cognitive Interviews with Decision Aid Developers
Hayes, T. (2016) · uO Research (University of Ottawa) · doi:10.20381/ruor-583

Authors: Bondemark, L., & Ruf, S.
Affiliations: Malmö University (SE)
ORCID: Bondemark, Lars
Ruf, Sabine
Venue: The European Journal of Orthodontics
Publisher: Oxford University Press (OUP)
Published: 2015-07-01
Volume: 37
Issue: 5
Pages: 457-461
ISSN: 0141-5387 (ISSN-L)
1460-2210
DOI: 10.1093/ejo/cjv046
OpenAlex: W2108187859
Cited by: 111
References: 0
Citations by year: 2026: 8 · 2025: 8 · 2024: 9 · 2023: 5 · 2022: 23 · 2021: 20 · 2020: 9 · 2019: 10 · 2018: 10 · 2017: 4 · 2016: 3 · 2015: 2
FWCI: 5.77
Type: journal article
Language: en
Open access: closed
Locations: European Journal of Orthodontics (publishedVersion)
PubMed (publishedVersion)
Malmö University Publications (Malmö University) (submittedVersion)
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Dentistry › Orthodontics › Orthodontics and Dentofacial Orthopedics
Keywords: randomized controlled trials, orthodontic research, evidence-based medicine, quality of evidence, research design, research reporting, clinical research quality
MeSH terms: Humans, Orthodontics, Review Literature as Topic, Meta-Analysis as Topic, Bias, Randomized Controlled Trials as Topic, Dental Research, Evidence-Based Dentistry, Checklist

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Randomized controlled trial: the gold standard or an unobtainable fallacy?

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