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| “Conform-Willingness controlled Trial” design:respect patients' wishes |
| Hits 1527 Download times 1551 Received:June 24, 2017 |
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| DOI
10.11656/j.issn.1672-1519.2017.11.06 |
| Key Words
Conform-Willingness;open-label design;clinical trial;ethics;will |
| Author Name | Affiliation | | ZHENG Wen-ke | Center for Evidence-Based Medicine, Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | ZHANG Jun-hua | Center for Evidence-Based Medicine, Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | WANG Hui | Center for Evidence-Based Medicine, Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | LIU Chun-xiang | Center for Evidence-Based Medicine, Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China |
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| Abstract
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| Randomized controlled trial (RCT) is recognized as the golden standard of clinical trials, while, the RCT has been questioned in ethics for it cannot guarantee the subjects' right to know, and leaving potential problems for cannot ensure the subjects compliance. Therefore, the author attempts to introduce a new clinical trial method named "Conform-Willingness controlled Trial" (CWT). In "CWT", the subjects should meet the inclusion/exclusion criteria, then based on the information of medicines which researchers offered, the subjects make decision themselves on take which medicine. Matched pairs method is used to keep the balance between two groups, and then evaluate the between-group differences. The "CWT" uses a series of method to control the quality of trial, they contain the third party to collect data, and second enrollment by matched pairs method. Blinded method were adopted in statistics, and so on. "CWT" can fully guarantee the patient's right to know, to improve patients compliance, raise the clinical curative effect of experimental drugs, and ensure the reliability of the results. We hope to provide a design for clinical evaluation on methodology. |
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