College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
College of Pharmacy, University of Sharjah, Sharjah, United Arab Emirates.
JAMA Oncol. 2023 Dec 1;9(12):1621-1626. doi: 10.1001/jamaoncol.2023.3996.
The pharmaceutical industry has made substantial investments in developing processes for sharing individual-participant data (IPD) from clinical trials. However, the utility and completeness of shared IPD and supporting documents must be evaluated to ensure the potential for scientific advancements from the data sharing ecosystem can be realized.
To assess the utility and completeness of IPD and supporting documents provided from industry-sponsored clinical trials.
DESIGN, SETTING, AND PARTICIPANTS: From February 9, 2022, to February 9, 2023, 91 of 203 clinical trials supporting US Food and Drug Administration registrations of anticancer medicines for the treatment of solid tumors from the past decade were confirmed as eligible for IPD request. This quality improvement study performed a retrospective audit of the utility and completeness of the IPD and supporting documents provided from the 91 clinical trials for a planned meta-analysis.
Request for IPD from 91 clinical oncology trials indicated as eligible for the request.
The utility and completeness of the IPD and supporting documents provided.
The IPD packages were obtained from 70 of 91 requested clinical trials (77%). The median time to data provision was 123 (range, 117-352) days. Redactions were observed in 18 of the acquired IPD packages (26%) for outcome data, 11 (16%) for assessment variables, and 19 (27%) for adjustment data. Additionally, 20 IPD packages (29%) lacked a clinical study report, 4 (6%) had incomplete or missing data dictionaries, and 20 (29%) were missing anonymization or redaction description files. Access to IPD from 21 eligible trials (23%) was not granted.
In this quality improvement study, there was substantial variability within the provided IPD packages regarding the completeness of key data variables and supporting documents. To improve the data sharing ecosystem, key areas for enhancement include (1) ensuring that clinical trials are eligible for IPD sharing, (2) making eligible IPD transparently accessible, and (3) ensuring that IPD packages meet a standard of utility and completeness.
制药行业在开发用于分享临床试验个体参与者数据（IPD）的流程方面进行了大量投资。然而，必须评估共享的 IPD 和支持文件的实用性和完整性，以确保数据共享生态系统有潜力实现科学进步。
评估来自行业赞助的临床试验提供的 IPD 和支持文件的实用性和完整性。
设计、设置和参与者：从 2022 年 2 月 9 日至 2023 年 2 月 9 日，确认过去十年中 203 项支持美国食品和药物管理局注册抗癌药物治疗实体瘤的临床试验中有 91 项符合 IPD 请求的资格。这项质量改进研究对 91 项临床试验的 IPD 和支持文件的实用性和完整性进行了回顾性审计，这些临床试验计划进行荟萃分析。
从 91 项临床肿瘤学试验中请求 IPD，这些试验被认为有资格进行请求。
提供的 IPD 和支持文件的实用性和完整性。
从请求的 91 项临床试验中获得了 70 项 IPD 包（77%）。数据提供的中位数时间为 123（范围为 117-352）天。在获得的 18 个 IPD 包（26%）中观察到结果数据的删减，11 个（16%）为评估变量，19 个（27%）为调整数据。此外，20 个 IPD 包（29%）缺少临床研究报告，4 个（6%）数据字典不完整或缺失，20 个（29%）缺少去识别或屏蔽描述文件。21 项符合条件的试验（23%）的 IPD 无法获得。
在这项质量改进研究中，提供的 IPD 包中关键数据变量和支持文件的完整性存在很大差异。为了改善数据共享生态系统，需要改进的关键领域包括（1）确保临床试验有资格进行 IPD 共享，（2）使合格的 IPD 透明可访问，以及（3）确保 IPD 包符合实用性和完整性标准。
