Poorly Recognized and Uncommonly Acknowledged Limitations of Randomized Controlled Trials

Randomized controlled trials (RCTs) are a gold standard in evidence-based research. However, RCTs have limitations, among which the most commonly acknowledged is that narrow study selection criteria compromise the external validity of the findings. This article briefly touches upon this and other we...

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Main Author: Chittaranjan Andrade
Format: Article
Language:English
Published: SAGE Publishing 2025-01-01
Series:Indian Journal of Psychological Medicine
Online Access:https://doi.org/10.1177/02537176241297953
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author Chittaranjan Andrade
author_facet Chittaranjan Andrade
author_sort Chittaranjan Andrade
collection DOAJ
description Randomized controlled trials (RCTs) are a gold standard in evidence-based research. However, RCTs have limitations, among which the most commonly acknowledged is that narrow study selection criteria compromise the external validity of the findings. This article briefly touches upon this and other well-recognized limitations and presents, in greater detail, less commonly acknowledged limitations with examples from contemporary literature. Important among the less commonly acknowledged limitations are biases in RCTs of interventions to which patients cannot be blinded, weaknesses in the design of maintenance therapy RCTs, and, ubiquitously, post-randomization biases. The listed limitations notwithstanding, RCTs are still the best among research designs. What is important is to recognize the imperfections in each RCT so that the findings of the RCT can be better judged.
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series Indian Journal of Psychological Medicine
spelling doaj-art-c8fe54baf72c4e5588f81f4abc03d2c72025-01-31T11:04:15ZengSAGE PublishingIndian Journal of Psychological Medicine0253-71760975-15642025-01-014710.1177/02537176241297953Poorly Recognized and Uncommonly Acknowledged Limitations of Randomized Controlled TrialsChittaranjan Andrade0 Dept. of Clinical Psychopharmacology and Neurotoxicology, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, India.Randomized controlled trials (RCTs) are a gold standard in evidence-based research. However, RCTs have limitations, among which the most commonly acknowledged is that narrow study selection criteria compromise the external validity of the findings. This article briefly touches upon this and other well-recognized limitations and presents, in greater detail, less commonly acknowledged limitations with examples from contemporary literature. Important among the less commonly acknowledged limitations are biases in RCTs of interventions to which patients cannot be blinded, weaknesses in the design of maintenance therapy RCTs, and, ubiquitously, post-randomization biases. The listed limitations notwithstanding, RCTs are still the best among research designs. What is important is to recognize the imperfections in each RCT so that the findings of the RCT can be better judged.https://doi.org/10.1177/02537176241297953
spellingShingle Chittaranjan Andrade
Poorly Recognized and Uncommonly Acknowledged Limitations of Randomized Controlled Trials
Indian Journal of Psychological Medicine
title Poorly Recognized and Uncommonly Acknowledged Limitations of Randomized Controlled Trials
title_full Poorly Recognized and Uncommonly Acknowledged Limitations of Randomized Controlled Trials
title_fullStr Poorly Recognized and Uncommonly Acknowledged Limitations of Randomized Controlled Trials
title_full_unstemmed Poorly Recognized and Uncommonly Acknowledged Limitations of Randomized Controlled Trials
title_short Poorly Recognized and Uncommonly Acknowledged Limitations of Randomized Controlled Trials
title_sort poorly recognized and uncommonly acknowledged limitations of randomized controlled trials
url https://doi.org/10.1177/02537176241297953
work_keys_str_mv AT chittaranjanandrade poorlyrecognizedanduncommonlyacknowledgedlimitationsofrandomizedcontrolledtrials