Cited by 292Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsEthics in Clinical Research

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Randomized controlled trials – a matter of design

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Siepmann, Timo, Spieth, Peter Markus, Kubasch, Anne Sophie, Penzlin, Ana Isabel, Illigens, Ben Min-Woo, Barlinn, Kristian·2016·Neuropsychiatric Disease and Treatment

DOI 10.2147/ndt.s101938PMC PMC4910682

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Abstract

Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.

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Figure 1 Flow diagram for parallel randomized trials comparing two groups. Notes: According to the CONSORT statement, the different phases of a randomized controlled trial can be separated into enrollment, allocation, follow-up, and data analysis. These phases should be described exactly with the respective number of patients to provide a quick and simple overview of the study process. Reproduced from Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010;11:32,13 with permission of BioMed Central. Abbreviation: CONSORT, Consolidated Standards of Reporting Trials.CC BY-NC · PubMed Central

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CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
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“The RRR frequently leads to overestimation of the treatment effects, so usually the ARR should be reported whenever possible.(15,35) The NNT is derived directly from the ARR and is calculated by dividing 1 by the ARR.”
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Authors: Siepmann, T., Spieth, P. M., Kubasch, A. S., Penzlin, A. I., Illigens, B. M.-W., & Barlinn, K.
Affiliations: John Radcliffe Hospital (GB)
Dresden International University (DE)
University Hospital Carl Gustav Carus (DE)
Beth Israel Deaconess Medical Center (US)
Corresponding author: Siepmann, Timo
ORCID: Siepmann, Timo
Spieth, Peter Markus
Kubasch, Anne Sophie
Barlinn, Kristian
Venue: Neuropsychiatric Disease and Treatment
Publisher: Informa UK Limited
Published: 2016-06
Volume: 12
Pages: 1341
ISSN: 1176-6328 (ISSN-L)
1178-2021
DOI: 10.2147/ndt.s101938
PMC: PMC4910682
OpenAlex: W2410316792
Cited by: 292
References: 66
Citations by year: 2026: 7 · 2025: 42 · 2024: 45 · 2023: 39 · 2022: 30 · 2021: 52 · 2020: 33 · 2019: 33 · 2018: 10 · 2017: 1
FWCI: 2.09
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by-nc
creativecommons.org/licenses/by-nc/3.0/ (vor)
Locations: Neuropsychiatric Disease and Treatment (publishedVersion, cc-by-nc)
PubMed Central (publishedVersion, cc-by-nc)
PubMed (publishedVersion)
Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
Qucosa (Saxon State and University Library Dresden) (submittedVersion, cc-by)
Funders: Technische Universität Dresden
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Keywords: randomized controlled trials, trial design, critical appraisal, equipoise, CONSORT statement, clinical trial registration, conflicts of interest, interim analysis, clinical trial reporting, end points, critical care research, brain research

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