Choosing a control intervention for a randomised clinical trial
BACKGROUND: Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for...
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Main Authors: | , |
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格式: | Artigo |
語言: | Inglês |
出版: |
BioMed Central
2003
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主題: | |
在線閱讀: | https://ncbi.nlm.nih.gov/pmc/articles/PMC165581/ https://ncbi.nlm.nih.gov/pubmed/12709266 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1471-2288-3-7 |
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Resumo: | BACKGROUND: Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. DISCUSSION: We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. SUMMARY: When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence. |
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