Compliance with adverse event reporting requirements in cancer clinical trials

遵守癌症临床试验中的不良事件报告要求

• 批准号: 7124548
• 负责人: Steven Joffe
• 金额: $ 25.5万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-07 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7124548
• 关键词: clinical research; clinical trials; literature survey; neoplasm /cancer

DESCRIPTION (provided by applicant): Complete and accurate reporting of adverse events (AEs) is a fundamental obligation of clinical investigators, with implications both for the safety of research participants and for the validity of the data derived from clinical research. The integrity of the AE reporting process hinges on self-regulation and professionalism among investigators, reinforced by audits by sponsors, regulatory agencies and research institutions. Yet virtually no data are available that might permit assessment of the quality of the AE reporting process. The present proposal is a preliminary study of the AE reporting process in cancer clinical trials. The proposal focuses on reporting to the institutional review board (IRB) of AEs that occur in adult phase II trials, which account for the largest proportion of trial participants at National Cancer Institute-designated Comprehensive Cancer Centers. Because methods for estimating the true incidence of AEs in clinical trials have not been developed, the proposal adapts chart review-based methods developed for identifying AEs in the routine clinical (non-research) setting to the clinical trial context. Specific Aims of the proposal include: 1) to estimate the incidence of reportable IRBs in phase II cancer trials; 2) to estimate the proportion of AEs that meet reporting criteria but are not reported to the IRB as required; and 3) to estimate the interrater reliability of reviewers' judgments concerning critical elements of AE determination, including severity, attribution to study interventions, and expectedness. The results of the study will provide initial data that will permit planning of definitive multicenter studies, and establishes a model and methodology for subsequent research on AEs and AE reporting both within and beyond cancer-related clinical research The project described here has important implications for public health. Each year, tens of thousands of patients take part in cancer trials, with many more participating in trials in other areas of medicine. The safety of these volunteers hinges critically on the integrity of the process by which investigators identify and report AEs to appropriate oversight bodies. In addition, accurate AE reporting affects the welfare of future patients whose treatment might be influenced by the outcomes of trials. Finally, public trust in and support for the research enterprise itself requires rigorous attention to the identification and management of adverse events.

描述（由申请人提供）：完整、准确地报告不良事件（ae）是临床研究者的基本义务，这既关系到研究参与者的安全性，也关系到临床研究数据的有效性。AE报告过程的完整性取决于调查人员的自我监管和专业精神，而发起人、监管机构和研究机构的审计又加强了这一点。然而，实际上没有可用的数据可以对AE报告过程的质量进行评估。本提案是对癌症临床试验中AE报告过程的初步研究。该提案的重点是向机构审查委员会（IRB）报告成人II期试验中发生的ae，这在国家癌症研究所指定的综合癌症中心的试验参与者中占最大比例。由于评估临床试验中不良事件真实发生率的方法尚未开发，因此该提案将用于识别常规临床（非研究）环境中不良事件的基于图表回顾的方法应用于临床试验环境。该提案的具体目的包括：1)估计II期癌症试验中可报告的irb的发生率；2)估计符合报告准则但未按规定向审核委员会报告的审计机构的比例；3)评估评价者对AE判定关键要素的判断的间信度，包括严重程度、研究干预的归因和预期。该研究的结果将提供初步数据，用于规划明确的多中心研究，并为癌症相关临床研究内外的AE和AE报告的后续研究建立模型和方法。每年，成千上万的患者参加癌症试验，还有更多的人参加其他医学领域的试验。这些志愿人员的安全在很大程度上取决于调查人员查明并向适当监督机构报告安全事故过程的完整性。此外，准确的AE报告会影响未来患者的福利，这些患者的治疗可能会受到试验结果的影响。最后，公众对研究企业本身的信任和支持要求严格关注不良事件的识别和管理。