Clinical Trial Transparency and Data-Sharing Among Bio-Pharmaceutical Companies and the Role of Company Size, Location, and Product Type: A Cross-Sectional Descriptive Analysis

Objective: To examine company characteristics associated with better transparency and to apply a tool used to measure and improve clinical trial transparency among large companies and drugs, to smaller companies and biologics.

Design: Cross-sectional descriptive analysis.

Setting and participants. Novel drugs and biologics FDA approved in 2016 and 2017, and their company sponsors.

Using established Good Pharma Scorecard (GPS) measures, companies and products were evaluated on their clinical trial registration, results dissemination, and FDA Amendments Act (FDAAA) implementation; Companies were ranked using these measures and a multi-component data sharing measure. Associations between company transparency scores with company size (large vs non-large), location (US vs non-US), and sponsored product type (drug vs biologic) were also examined. 26% of products (16/62) had publicly available results for all clinical trials supporting their FDA approval and 67% (39/58) had public res...

研究目标：探讨与更高临床试验透明度相关的企业特征，并将原本用于大型企业及药品的临床试验透明度测评与优化工具，拓展应用至小型企业与生物制品领域。
研究设计：横断面描述性分析。
研究对象与场景：2016年与2017年获美国食品药品监督管理局（FDA）批准的新型药品与生物制品，及其所属企业赞助方。
采用成熟的优质药企评分卡（Good Pharma Scorecard, GPS）测评指标，对企业及其产品的临床试验注册、试验结果披露以及《FDA修正案》（FDA Amendments Act, FDAAA）的执行情况进行评估；基于上述指标与多维度数据共享测评指标对企业进行排名。同时分析企业透明度评分与企业规模（大型与非大型）、注册所在地（美国境内与境外）以及赞助产品类型（药品与生物制品）之间的关联。本次纳入的产品中，26%（16/62）的产品拥有支持其FDA获批的全部临床试验的公开结果，67%（39/58）的产品拥有公开的……