Research for Adverse Drug-Events And Reports (RADAR)

描述（由申请人提供）：严重药物不良反应（sADR）每年导致超过100，000例死亡。对药物sADR信息识别和传播障碍的调查可能对患者安全、挽救生命和确定未来政策变化的领域有直接益处。这些考虑因素对癌症药物尤其重要，重点是加快FDA批准和缩短审查时间，这引起了人们对sADR的关注可能不够的担忧。 在本研究中，我们建议描述1996年至2003年期间确定的与肿瘤药物相关的所有sADR。我们会对MedWatch进行全面搜查（FDA的自愿报告系统），肿瘤学合作组毒性报告，MedLine和其他电子数据库，主要健康会议摘要，欧洲，澳大利亚和加拿大的药物警戒计划网站，“亲爱的医生”信件，和FDA对肿瘤药物的所有sADR进行包装标签修订，并汇编和报告每种sADR的完整病例系列信息。我们的初步分析表明，我们将在检索中确定80至100种sADR。我们还将描述sADR的传播工作，并确定与每个sADR的识别和传播相关的相关里程碑。这些里程碑包括：新药申请（NDA）日期、临床数据包提交以供FDA批准的日期、FDA批准日期、向FDA报告首个sADR的日期、向FDA报告第10例病例的日期以及开发综合病例系列并在同行评审文献、致医生信函和药品说明书中报告的日期。此外，我们还将评估从首次申请FDA批准到将sADR作为一组和几个单独的sADR特征识别和报告的时间之间的关系。我们的初步研究表明，在过去5年中发现的既往未报告的sADR中，只有30%在文献中得到了描述，对于已报告的sADR，传播工作往往被延迟。本研究的结果将：1）提供关于癌症药物相关sADR的更全面和最新信息，2）提供关于识别和报告这些重要临床事件的障碍的第一组经验数据。

DESCRIPTION (provided by applicant): Serious adverse drug reactions (sADRs) account for over 100,000 deaths annually. Investigation into barriers in identification and dissemination of sADR information for drugs is likely to have a direct benefit on patient safety, save lives, and identify areas for future policy changes. These considerations are especially important for cancer drugs, where the emphasis has been on accelerated FDA approval and shorter review times, raising concern that attention to sADRs may not be sufficient. In this study, we propose to describe all sADRs associated with oncology drugs that were identified between 1996 and 2003. We will conduct a comprehensive search of MedWatch (the FDA's voluntary reporting system), cooperative oncology group toxicity reports, MedLine and other electronic databases, abstracts from major health conferences, pharmacovigilance program websites from Europe, Australia, and Canada, "Dear Doctor" letters, and FDA package label revisions for all sADRs for oncology drugs and compile and report complete case series information on each of these sADRs. Our preliminary analyses suggest that we will identify between 80 and 100 sADRs in our search. We will also describe dissemination efforts for the sADRs and identify the relevant milestones related to identification and dissemination of each sADR. These milestones include: the date of New Drug Application (NDA), date of submission of clinical packet for consideration of FDA approval, date of FDA approval, date of reporting of the first sADR to the FDA, date of reporting of the 10th case to the FDA, and date for which a comprehensive case series was developed and reported in the peer-reviewed literature, Dear Doctor letters, and package inserts. Additionally, we will assess the relationship between time from initial application for FDA approval to identification and reporting of the sADRs as a group and of several individual sADR characteristics. Our preliminary studies indicate that only 30% of previously unreported sADRs identified in the past five years have been described in the literature, and for the reported sADRs, dissemination efforts were often delayed. The findings of this study would: 1) provide more comprehensive and current information about sADRs associated with cancer drugs and 2) provide the first set of empirical data on barriers to identification and reporting of these important clinical events.