Stowe S M, Hammond G D, Chard R, Hornberger J A, Honour R C, Sposto R, Weiner J M
Am J Clin Oncol. 1984 Oct;7(5):557-66.
This report describes an evaluative approach in assessing study quality in clinical trials. The size of the data set required is defined using decision analysis methods. Assuming entry of eligible patients, the minimum data set required in determining study quality includes: the treatment agent, the protocol stipulated treatment time, and the actual time of administration. While toxicity, complication and response data are primary for the resolution of the scientific issues, they are secondary for study performance questions. Separation of study performance and scientific questions simplifies the design and execution of complex, multimodal, multidisciplinary clinical trials. Application of separate criteria for study performance and scientific questions enhances understanding of protocol requirements by data managers, physicians, and nurses. Once study performance issues are resolved, the scientific issues addressed by the protocol can be considered in detail. The usual practice of focusing on science and study performance simultaneously precludes efficient consideration of either data set. The distinction between analyses of study performance and of scientific questions is illustrated using data from Childrens Cancer Study Group protocol CCG-551. This study is a controlled trial of therapies for non-Hodgkin's lymphoma. The protocol provides an example of modern diagnostic and therapeutic management complexities.
本报告描述了一种评估临床试验研究质量的方法。所需数据集的大小通过决策分析方法来确定。假设符合条件的患者入组，确定研究质量所需的最小数据集包括：治疗药物、方案规定的治疗时间以及实际给药时间。虽然毒性、并发症和反应数据对于解决科学问题至关重要，但对于研究执行问题而言则是次要的。将研究执行和科学问题分开，可简化复杂的多模式、多学科临床试验的设计与实施。针对研究执行和科学问题应用不同的标准，可增强数据管理人员、医生和护士对方案要求的理解。一旦研究执行问题得到解决，就可以详细考虑方案所涉及的科学问题。同时关注科学和研究执行的常规做法会妨碍对任何一个数据集进行有效的考量。使用儿童癌症研究组方案CCG - 551的数据说明了研究执行分析与科学问题分析之间的区别。这项研究是针对非霍奇金淋巴瘤治疗的对照试验。该方案体现了现代诊断和治疗管理的复杂性。
