Quality of Research on Treatment Harms in Cancer

描述(由申请人提供)：在卫生保健方面做出明智的决策需要平衡与治疗相关的益处和危害的信息。如果关于危害的数据是无效的，没有记录，或在已发表的研究结果中被抑制，那么医生将不会拥有最佳处方所需的所有数据。因此，拥有关于益处和危害的准确、可靠和充分报告的数据是一个重要的研究完整性问题。美国国家癌症研究所(NCI)通过其合作小组(COG)机制进行了大部分公共资助的随机对照试验(RCT)。因此，我们建议对NCI-Cogs进行的随机对照试验进行全面的总体评估，以评估收集和报告危害数据的充分性。我们建议在癌症随机对照试验中研究以下与治疗相关的损害相关的具体目标：1.我们将通过总结与损害相关的最重要质量领域的数据来确定从已发表的报告中报告损害数据的质量。 2.我们将评估NCI赞助的临床研究在多大程度上存在结果报告偏差。我们将通过确定危害评估是原始COG研究方案中指定的优先事项的频率，然后将这些方案与最终出版物进行比较来衡量结果报告偏差。3.我们将在同时评估益处和危害的基础上，与仅选择性地考虑益处的基础上，评估研究人员是否偏爱一种治疗方法。这项拟议的研究将首次提供在随机临床试验中未能充分报告危害的系统数据，这是一项重大的有问题的研究实践。这些发现还将为研究人员和资助机构/政策制定者(包括NCI和资助癌症治疗系统审查的医疗研究和质量机构)考虑研究质量标准提供信息。如果我们发现系统性的治疗报告不充分，NCI将能够立即采取纠正行动，以提高随机对照试验的方法学质量和其资助的临床试验的报告标准。最后，危害报告的改进将使医生受益，尤其是患者，他们需要了解他们接受的治疗的潜在危害。

DESCRIPTION (provided by applicant): Informed decision making in health care requires a balancing of information on benefit and harms associated with treatments. If data on harms are not valid, not recorded, or suppressed in the published findings, then doctors will not have all data that are needed for optimal prescribing. Therefore, having accurate, reliable, and adequately reported data on both benefits and harms is an important research-integrity issue. The National Cancer Institute (NCI) via its cooperative group (COG) mechanism in the USA conducts the majority of the publicly funded randomized controlled trials (RCTs). Hence, we propose to evaluate a comprehensive population of RCTs conducted by the NCI-COGs to assess the adequacy of collecting and reporting data on harms. We propose to study the following specific aims related to treatment-associated harms in cancer randomized controlled trials: 1. We will determine the quality of reporting of data on harms from published reports by summarizing data on the most important quality domains related to harm. 2. We will assess the extent to which outcome reporting bias exists in the NCI-sponsored clinical research. We will measure outcome reporting bias by determining how often the assessment of harms was a priority specified in the original COG research protocols, and then comparing the protocols against the final publications. 3. We will evaluate whether investigators favored one treatment over another on the basis of simultaneous assessment of benefits and harms versus selective consideration of benefits only. The proposed research will provide the first systematic data on failures to adequately report harms in randomized clinical triasl, a significant questionable research practice. The findings will also inform considerations of research quality standards by both researchers and funding agency/policy-makers (including the NCI and the Agency for Healthcare Research and Quality, which funds systematic reviews on cancer treatments). If we find systematic inadequate reporting of treatment harms, the NCI will be able to undertake immediate corrective actions to improve methodological quality of RCTs and the standards of reporting of clinical trials it funds. Finally, the improvement of the reporting of harms would benefit physicians and above all patients, who need to understand the potential harms of the treatments they receive.