Summary of transparency measures
| Trial samples | Outcome measures | % of company score |
| Data sharing trials (generally completed phase II and III trials) | Registration by 6 months of FDA product approval or 18 months after a trial’s completion date, whichever is later | 33.3* |
| Policy commits to providing access to analysis-ready dataset and clinical study report | ||
| Policy explains how data may be requested | ||
| Company reports number and outcome of data requests | ||
| Policy specifies data will be shared by 6 months of FDA product approval or 18 months after a trial’s completion date, whichever is later | ||
| Patient trials (targeted patient population for approved indication; excludes trials in healthy volunteers) | Results publicly available (reported or published) by 6 months after FDA approval of studied indication*† | 33.3 |
| FDAAA applicable trials (generally non-phase I trials with a US site or by a US-based manufacturer) | Registration by 21 days of trial start date and results reported by 30 days after FDA approval of studied indication | 33.3 |
| All trials supporting approval (includes trials in healthy volunteers and trials for unapproved indications in NDA or BLA) | Results publicly available by 6 months after FDA approval of studied indication†‡ | 0 |
| Total | 100 | |
*Data sharing score is the average of the five data sharing outcome measure scores.
†Excludes trials that are phase I, expanded access, terminated without enrolment, for unapproved indications, and (if requested) with high reidentification risk.
‡Can include linking to a clinical study report synopsis within a clinical trial registry.
BLA, biologic license application; EMA, European Medicines Agency; FDA, Food and Drug Administration; FDAAA, FDA Amendments Act; NDA, new drug application.