EVALUATION OF SAFETY DATA REPORTING IN RANDOMIZED TRIALS

随机试验中安全数据报告的评估

• 批准号: 6053928
• 负责人: JOSEPH LAU
• 金额: $ 7.89万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2000-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6053928
• 关键词: HIV infections; Helicobacter; clinical trials; health science research analysis /evaluation; health services research tag; human data; hypertension; meta analysis; myocardial infarction; rheumatoid arthritis; sinusitis; toxicology

We propose to evaluate the quality and extent of safety information in published randomized trials across several medical disciplines and to identify factors that affect the reporting of safety data in these reports. Such trials offer a unique opportunity for assembling information on the toxicity profile of new interventions in a controlled, comprehensive setting. This information cannot be substituted from small, selective early phase I/II trials or the sporadic post-marketing experience. The evaluation of safety reporting from randomized trials is a neglected field. However, clinicians cannot make informed risk-benefit decisions without adequate information on the toxicity of specific medical interventions beyond efficacy estimates. We have developed scales for evaluating safety reporting in randomized trials and have applied them to all trials in the field of HIV therapeutics. Glaring deficiencies were observed in the reporting of discontinuations due to toxicity and the reporting of specific side effects. The journal space allocated to safety results was slightly less than that allocated for contributor names. In this project, we will assess the qualitative and quantitative adequacy of safety reporting in comprehensive databases of randomized comparative trials in 7 different clinical fields; HIV infection, thrombolytic therapy in acute myocardial infarction, treatment of hypertension in the elderly, antibiotic therapy for acute sinusitis, non-steroidal agents for rheumatoid arthritis, treatment for Helicobacter pylori, and selective decontamination of the gastrointestinal tract in the intensive care setting. A meta-analysis of the estimates of safety reporting across these fields will be used to assess field-specific heterogeneity and to calculate overall pooled estimates, if appropriate. The project is expected to detect deficiencies in current reporting of safety data and show how the situation can be improved in the future, thus promoting the potential for the application of evidence-based medicine in clinical practice.

我们建议评价多个医学学科已发表的随机试验中安全性信息的质量和范围，并确定影响这些报告中安全性数据报告的因素。 这些试验提供了一个独特的机会，可以在一个受控的综合环境中收集关于新干预措施的毒性特征的信息。 这些信息不能从小型、选择性早期I/II期试验或零星上市后经验中替代。 随机试验安全性报告的评价是一个被忽视的领域。 然而，临床医生不能作出知情的风险-受益决定，没有足够的信息，毒性的具体医疗干预措施超出疗效估计。 我们开发了用于评估随机试验中安全性报告的量表，并将其应用于HIV治疗领域的所有试验。 在因毒性而停药的报告和特定副作用的报告中观察到了明显的缺陷。 分配给安全性结果的期刊空间略少于分配给贡献者名称的期刊空间。 在本项目中，我们将评估7个不同临床领域随机对照试验综合数据库中安全性报告的定性和定量充分性; HIV感染、急性心肌梗死的溶栓治疗、老年人高血压的治疗、急性鼻窦炎的抗生素治疗、类风湿性关节炎的非甾体类药物、幽门螺杆菌的治疗、以及在重症监护环境中胃肠道的选择性净化。 将使用这些领域安全性报告估计值的荟萃分析评估领域特异性异质性，并计算总体汇总估计值（如适用）。 该项目有望发现目前安全性数据报告中的缺陷，并展示未来如何改善这种情况，从而促进循证医学在临床实践中的应用潜力。