Table 1.
Platform | Reference | Time-Frame of Access | Type of Data Shared | Total # of Trials Hosted | Total # of Requests | Total # Granted or Approved |
---|---|---|---|---|---|---|
Data Reports Submitted for Regulatory Approval | ||||||
European Medicines Agency | Bonini et al.8 | 2010–2013 | Any data submitted for marketing authorization of any medicinal product | – | 750 | 480 |
Federally-Funded Clinical Studies | ||||||
NHLBI Data Repository | Coady et al.12 | 2000–2016 | Patient-level data from large NHLBI-supported trials and observational studies | 100 | 800–850 | – |
Industry-Sponsored Clinical Studies | ||||||
CSDR, SOAR Initiative, and YODA Project | Navar et al.14 | 2013–2015 | Patient-level data from select clinical studies sponsored by 14 companies | 3,255 | 234 | 154 |
CSDR | Strom et al.16 | 2013–2015 | Patient-level data from select clinical studies sponsored by 13 companies | 3,049 | 177 | 144 |
Strom et al.15 | 2013–2014 | Patient-level data from select clinical studies sponsored by 10 companies | >1,200 | 58 | 36 | |
YODA Project | Krumholz et al.13 | 2014–2015 | Patient-level data from select trials sponsored by Johnson & Johnson | 123 | 29 | 29 |
Abbreviations: CSDR = ClinicalStudyDataRequest.com; NHLBI = National Heart, Lung, and Blood Institute; SOAR = Supporting Open Access to Researchers; YODA = The Yale Open Data Access.