Quality of Research on Treatment Harms in Cancer

描述（由申请人提供）：医疗保健中的知情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无效，没有记录，或者在已发表的研究结果中被抑制，那么医生将无法获得最佳处方所需的所有数据。因此，拥有准确、可靠和充分报告的利弊数据是一个重要的研究诚信问题。美国国家癌症研究所（NCI）通过其合作小组（COG）机制进行了大多数公共资助的随机对照试验（rct）。因此，我们建议对NCI-COGs进行的一组综合随机对照试验进行评估，以评估收集和报告危害数据的充分性。我们建议研究以下与癌症随机对照试验中治疗相关危害相关的具体目标：1。我们将通过总结与危害相关的最重要质量领域的数据来确定已发表报告中危害数据报告的质量。

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.