Abstract：
After the approval of a new drug, the Food and Drug Administration (FDA) may issue postmarketing requirements (PMRs), studies that the law requires manufacturers to conduct for drugs approved under certain conditions, and postmarketing commitments (PMCs), studies that the FDA and manufacturers agree should be conducted as a condition of approval.
With regulators\' increasing reliance on gathering important evidence after initial product approval, we sought to assess the track record of PMRs and PMCs by synthesizing information about postmarketing study completion rates, timeliness, study types, and results reporting.
A systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was conducted. Studies published in academic journals or government reports that reported original data about the characteristics of PMRs or PMCs were included. Studies of post-approval trial mandates issued by regulators outside the USA were excluded, as were those that addressed post-approval research without mentioning either PMCs or PMRs or a specific approval pathway associated with statutorily required PMRs. Two investigators independently screened and extracted data from studies and reports. Data sources included the Federal Register from 2003 to 2020, FDA backlog reviews from 2008 to 2020, PubMed from January 2006 to April 2021, and the US Government Accountability Office (GAO) database for reports from January 2006 to April 2021. PMR/PMC characteristics (e.g., completion rates, timeliness, results reporting, outcomes) were not meta-analyzed due to the heterogeneity in study designs.
Twenty-seven peer-reviewed articles from PubMed, five GAO reports, 17 annual Federal Register notices, and 12 annual backlog reviews were included. Among the 27 studies, 13 reviewed PMRs and PMCs, one reviewed only PMCs, and 13 reviewed only PMRs. A majority of new drugs were approved with at least one PMR or PMC. PMCs were completed at higher rates than PMRs, although delays were common and neither was found to be completed more than two-thirds of the time. Over two-thirds of PMRs and PMCs reported their findings in publications and trial registries. Over half of PMCs and PMRs produced novel information for clinical practice or leading to regulatory action, such as confirmation of benefit or a labeling change.
PMRs and PMCs are common for new drugs and can lead to worthwhile outcomes, but are often delayed or incomplete. Greater attention is needed to timely completion, improving transparency of findings, and ensuring that PMRs and PMCs produce optimally useful information for prescribers and patients.
With regulators\' increasing reliance on gathering important evidence after initial product approval, we sought to assess the track record of PMRs and PMCs by synthesizing information about postmarketing study completion rates, timeliness, study types, and results reporting.
A systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was conducted. Studies published in academic journals or government reports that reported original data about the characteristics of PMRs or PMCs were included. Studies of post-approval trial mandates issued by regulators outside the USA were excluded, as were those that addressed post-approval research without mentioning either PMCs or PMRs or a specific approval pathway associated with statutorily required PMRs. Two investigators independently screened and extracted data from studies and reports. Data sources included the Federal Register from 2003 to 2020, FDA backlog reviews from 2008 to 2020, PubMed from January 2006 to April 2021, and the US Government Accountability Office (GAO) database for reports from January 2006 to April 2021. PMR/PMC characteristics (e.g., completion rates, timeliness, results reporting, outcomes) were not meta-analyzed due to the heterogeneity in study designs.
Twenty-seven peer-reviewed articles from PubMed, five GAO reports, 17 annual Federal Register notices, and 12 annual backlog reviews were included. Among the 27 studies, 13 reviewed PMRs and PMCs, one reviewed only PMCs, and 13 reviewed only PMRs. A majority of new drugs were approved with at least one PMR or PMC. PMCs were completed at higher rates than PMRs, although delays were common and neither was found to be completed more than two-thirds of the time. Over two-thirds of PMRs and PMCs reported their findings in publications and trial registries. Over half of PMCs and PMRs produced novel information for clinical practice or leading to regulatory action, such as confirmation of benefit or a labeling change.
PMRs and PMCs are common for new drugs and can lead to worthwhile outcomes, but are often delayed or incomplete. Greater attention is needed to timely completion, improving transparency of findings, and ensuring that PMRs and PMCs produce optimally useful information for prescribers and patients.
摘要：
在新药获得批准后,美国食品和药物管理局(FDA)可能会发布上市后要求(PMR)，法律要求制造商对在特定条件下批准的药物进行的研究，和上市后承诺(PMC)，FDA和制造商同意的研究应作为批准的条件进行。
随着监管机构越来越依赖在初始产品批准后收集重要证据，我们试图通过综合有关上市后研究完成率的信息来评估PMR和PMC的跟踪记录，及时性、及时性研究类型,和结果报告。
根据系统评价和荟萃分析（PRISMA）指南的首选报告项目进行系统评价。包括在学术期刊或政府报告中发表的有关PMR或PMC特征的原始数据的研究。美国以外的监管机构发布的批准后试验授权的研究被排除在外，在没有提及PMC或PMR或与法定要求的PMR相关的特定批准途径的情况下，涉及批准后研究的研究也是如此。两名研究者从研究和报告中独立筛选和提取数据。数据来源包括2003年至2020年的联邦公报，2008年至2020年的FDA积压审查，2006年1月至2021年4月的PubMed，以及2006年1月至2021年4月的美国政府问责办公室（GAO）数据库。PMR/PMC特性(例如，完成率，及时性、及时性结果报告，结局）由于研究设计的异质性，未进行荟萃分析。
来自PubMed的27篇同行评审文章，五份GAO报告,17份年度联邦登记册通知，包括12项年度积压审查。在27项研究中，13审查了PMR和PMC，一个只审查了PMC，13只审查了PMR。大多数新药被批准至少一种PMR或PMC。PMC的完成率高于PMR，尽管延误很普遍，而且没有发现超过三分之二的时间完成。超过三分之二的PMR和PMC在出版物和试验登记处报告了他们的发现。超过一半的PMC和PMR产生了用于临床实践或导致监管行动的新信息。如福利确认或标签变更。
PMR和PMC对于新药来说是常见的，可以带来有价值的结果。但往往是延迟或不完整的。需要更加注意及时完成，提高调查结果的透明度，并确保PMR和PMC为处方者和患者提供最佳有用信息。
随着监管机构越来越依赖在初始产品批准后收集重要证据，我们试图通过综合有关上市后研究完成率的信息来评估PMR和PMC的跟踪记录，及时性、及时性研究类型,和结果报告。
根据系统评价和荟萃分析（PRISMA）指南的首选报告项目进行系统评价。包括在学术期刊或政府报告中发表的有关PMR或PMC特征的原始数据的研究。美国以外的监管机构发布的批准后试验授权的研究被排除在外，在没有提及PMC或PMR或与法定要求的PMR相关的特定批准途径的情况下，涉及批准后研究的研究也是如此。两名研究者从研究和报告中独立筛选和提取数据。数据来源包括2003年至2020年的联邦公报，2008年至2020年的FDA积压审查，2006年1月至2021年4月的PubMed，以及2006年1月至2021年4月的美国政府问责办公室（GAO）数据库。PMR/PMC特性(例如，完成率，及时性、及时性结果报告，结局）由于研究设计的异质性，未进行荟萃分析。
来自PubMed的27篇同行评审文章，五份GAO报告,17份年度联邦登记册通知，包括12项年度积压审查。在27项研究中，13审查了PMR和PMC，一个只审查了PMC，13只审查了PMR。大多数新药被批准至少一种PMR或PMC。PMC的完成率高于PMR，尽管延误很普遍，而且没有发现超过三分之二的时间完成。超过三分之二的PMR和PMC在出版物和试验登记处报告了他们的发现。超过一半的PMC和PMR产生了用于临床实践或导致监管行动的新信息。如福利确认或标签变更。
PMR和PMC对于新药来说是常见的，可以带来有价值的结果。但往往是延迟或不完整的。需要更加注意及时完成，提高调查结果的透明度，并确保PMR和PMC为处方者和患者提供最佳有用信息。
