Abstract：
OBJECTIVE: Clinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years, major entities including the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA) have highlighted the importance of CSR accessibility. The primary objective herein was to determine the proportion of CSRs that support medicine approvals available for public download as well as the proportion eligible for independent researcher request via the study sponsor.
METHODS: This cross-sectional study examined the accessibility of CSRs from industry-sponsored clinical trials whose results were reported in the FDA-authorized drug labels of the top 30 highest-revenue medicines of 2021. We determined (1) whether the CSRs were available for download from a public repository, and (2) whether the CSRs were eligible for request by independent researchers based on trial sponsors\' data sharing policies.
RESULTS: There were 316 industry-sponsored clinical trials with results presented in the FDA-authorized drug labels of the 30 sampled medicines. Of these trials, CSRs were available for public download from 70 (22%), with 37 available at EMA and 40 at Health Canada repositories. While pharmaceutical company platforms offered no direct downloads of CSRs, sponsors confirmed that CSRs from 183 (58%) of the 316 clinical trials were eligible for independent researcher request via the submission of a research proposal. Overall, 218 (69%) of the sampled clinical trials had CSRs available for public download and/or were eligible for request from the trial sponsor.
CONCLUSIONS: CSRs were available from 69% of the clinical trials supporting regulatory approval of the 30 medicines sampled. However, only 22% of the CSRs were directly downloadable from regulatory agencies, the remaining required a formal application process to request access to the CSR from the study sponsor.
METHODS: This cross-sectional study examined the accessibility of CSRs from industry-sponsored clinical trials whose results were reported in the FDA-authorized drug labels of the top 30 highest-revenue medicines of 2021. We determined (1) whether the CSRs were available for download from a public repository, and (2) whether the CSRs were eligible for request by independent researchers based on trial sponsors\' data sharing policies.
RESULTS: There were 316 industry-sponsored clinical trials with results presented in the FDA-authorized drug labels of the 30 sampled medicines. Of these trials, CSRs were available for public download from 70 (22%), with 37 available at EMA and 40 at Health Canada repositories. While pharmaceutical company platforms offered no direct downloads of CSRs, sponsors confirmed that CSRs from 183 (58%) of the 316 clinical trials were eligible for independent researcher request via the submission of a research proposal. Overall, 218 (69%) of the sampled clinical trials had CSRs available for public download and/or were eligible for request from the trial sponsor.
CONCLUSIONS: CSRs were available from 69% of the clinical trials supporting regulatory approval of the 30 medicines sampled. However, only 22% of the CSRs were directly downloadable from regulatory agencies, the remaining required a formal application process to request access to the CSR from the study sponsor.
摘要：
目的：临床研究报告（CSR）是非常详细的文件，在药物审批过程中起着关键作用。虽然历史上没有公开，近年来，包括欧洲药品管理局(EMA)在内的主要实体，加拿大卫生部,美国食品和药物管理局(FDA)强调了企业社会责任可及性的重要性。本文的主要目标是确定支持可供公开下载的药物批准的CSR的比例以及通过研究赞助者有资格获得独立研究人员请求的比例。
方法：这项横断面研究检查了行业赞助的临床试验中CSR的可及性，这些临床试验的结果已在FDA授权的2021年收入最高的30种药物的药品标签中报告。我们确定1)CSR是否可从公共存储库下载，以及2)根据试验赞助者的数据共享政策,CSR是否符合独立研究者的要求.
结果：共有316项行业赞助的临床试验，其结果在30种样本药物的FDA授权药物标签中呈现。在这些试验中,CSR可从70（22％）公开下载，其中37种可在EMA获得，40种可在加拿大卫生部存储库获得。虽然制药公司平台没有提供CSR的直接下载，通过提交研究提案,研究者确认316项临床试验中183项(58%)的CSR符合独立研究者的要求.总的来说,218（69％）的样本临床试验具有可供公开下载的CSR和/或符合试验赞助商的要求。
结论：CSR可从69%的临床试验中获得，这些临床试验支持30种药物的监管部门批准。然而,只有22%的CSR可以直接从监管机构下载，其余的需要一个正式的申请程序,以请求研究申办方访问CSR.
方法：这项横断面研究检查了行业赞助的临床试验中CSR的可及性，这些临床试验的结果已在FDA授权的2021年收入最高的30种药物的药品标签中报告。我们确定1)CSR是否可从公共存储库下载，以及2)根据试验赞助者的数据共享政策,CSR是否符合独立研究者的要求.
结果：共有316项行业赞助的临床试验，其结果在30种样本药物的FDA授权药物标签中呈现。在这些试验中,CSR可从70（22％）公开下载，其中37种可在EMA获得，40种可在加拿大卫生部存储库获得。虽然制药公司平台没有提供CSR的直接下载，通过提交研究提案,研究者确认316项临床试验中183项(58%)的CSR符合独立研究者的要求.总的来说,218（69％）的样本临床试验具有可供公开下载的CSR和/或符合试验赞助商的要求。
结论：CSR可从69%的临床试验中获得，这些临床试验支持30种药物的监管部门批准。然而,只有22%的CSR可以直接从监管机构下载，其余的需要一个正式的申请程序,以请求研究申办方访问CSR.
