When Ethics Precludes Randomization: Put Prospective, Matched-Pair Observational Studies to Work

Randomized, controlled clinical trials (RCTs) may be possible, permissible, and practical in certain circumstances, but ethical or practical considerations often preclude their utilization. In many such cases, ethical objections will not apply to a similarly oriented, prospective, matched-pair obser...

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Bibliographic Details
Published in:Perspectives in biology and medicine 2013, Vol.56 (2), p.184-197
Main Author: Kowalski, Charles Joseph
Format: Article
Language:English
Subjects:
Clinical trials
Ethics, Medical
Evidence-based medicine
Mortality
Patients
Pragmatism
Prospective Studies
Randomized Controlled Trials as Topic
Studies
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Summary:Randomized, controlled clinical trials (RCTs) may be possible, permissible, and practical in certain circumstances, but ethical or practical considerations often preclude their utilization. In many such cases, ethical objections will not apply to a similarly oriented, prospective, matched-pair observational study. Additionally, if the methodological rigor associated with the RCT is maintained, potential epistemic losses due to eliminating randomization will be mitigated. It is therefore suggested that when ethics precludes randomization, prospective, protocol-driven, matched-pair observational studies be put to work. One can also envision extending observational studies beyond their traditional time-dependent bounds to encompass never-ending activities focused on the accumulation of clinical knowledge in real-world settings.
ISSN:0031-5982
1529-8795
1529-8795
DOI:10.1353/pbm.2013.0014