J.Jpn. Surg. Soc.. 125(2): 120-123, 2024

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Feature topic

RANDOMIZED, CONTROLLED TRIALS IN BREAST DISEASES

Prospectively designed randomized, controlled clinical trials (RCTs) in the breast field mainly focus on drug therapy, surgical therapy, radiotherapy, and screening, and recently studies have also begun to be conducted on the performance evaluation of diagnostic assays. Phase 3 controlled trials often result in a practice changing if significant outcomes are achieved. Therefore, the results are often published in prestigious general journals in the medical field or high-grade specialty journals. If a phase 3 comparative study is well designed, rigorously conducted and analyzed, and reported accurately and precisely as planned, publication in well-regarded journals is likely. When planning and executing a trial, it is important to confirm that the theory is properly developed and elaborately constructed, the design is sufficiently creative, a collaborative team for implementation is created, and a cooperative environment with the social system is prepared. In addition, continuous checking and objective assessment of the key points, such as a patient-first policy and conditions of trial progress, are basic requirements throughout the entire RCT process.

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