General principles of surgery quality control.
Randomized clinical trials are currently the most reliable research technique to generate reliable treatment data. Quality control and monitoring with statistical credibility are essential. This requires nurse data managers and coordinators and statisticians, as well as the surgeons and physicians. A well-structured operating infrastructure is key. From the surgical point of view, careful intraoperative staging and standardization of the surgical procedures are a must. Strict eligibility criteria must be documented and enforced. Finally, careful stratification for prognostic variables before randomization in phase 3 trials is essential.
Holmes
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Department of Surgery/Oncology, University of California at Los Angeles.
D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology* / Q000601:surgery*; D008207:Lymphatic Metastasis; D008482:Mediastinum; D008495:Medical Oncology / Q000592:standards*; D009367:Neoplasm Staging; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic; D013908:Thoracotomy