Research for Adverse Drug-Events And Reports (RADAR)

描述(由申请人提供)：严重的药物不良反应(SADR)每年导致超过10万人死亡。对识别和传播药品SADR信息的障碍进行调查，可能会直接有利于患者的安全，拯救生命，并确定未来政策变化的领域。这些考虑对抗癌药物尤其重要，重点一直是加快FDA的批准和缩短审查时间，这引发了人们对sADRs的关注可能不够的担忧。 在这项研究中，我们建议描述1996至2003年间发现的所有与肿瘤药物相关的sADR。我们将对MedWatch(FDA的自愿报告系统)、合作肿瘤学小组毒性报告、Medline和其他电子数据库、主要健康会议的摘要、来自欧洲、澳大利亚和加拿大的药物警戒计划网站、亲爱的医生信件以及FDA对所有肿瘤药物sADR的包装标签修订进行全面搜索，并汇编和报告关于每个sADR的完整病例系列信息。我们的初步分析表明，我们将在搜索中识别80到100个sadr。我们还将介绍《战略、任务和结果报告》的传播工作，并确定与确定和传播每一项战略目标相关的里程碑。这些里程碑包括：新药申请日期(NDA)，提交临床分组供FDA批准的日期，FDA批准的日期，第一个SADR向FDA报告的日期，第10个病例向FDA报告的日期，以及在同行评议文献、尊敬的医生信函和包装插页中开发和报告综合病例系列的日期。此外，我们将评估从最初申请FDA批准到识别和报告sADR作为一个整体以及几个单独的SADR特征之间的关系。我们的初步研究表明，在过去五年中发现的以前未报告的sADR中，只有30%在文献中得到了描述，对于已报告的sADR，传播努力往往被推迟。这项研究的结果将：1)提供与抗癌药物相关的sADR的更全面和最新的信息；2)提供第一组关于识别和报告这些重要临床事件的障碍的经验数据。

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.