Table 1 Details of YODA Project inquiry process for Johnson & Johnson clinical trials as of August 27, 2018.
From: Overview and experience of the YODA Project with clinical trial data sharing after 5 years
Total inquiries, No. | 161 |
Total inquiries answered to date, No. (%) | 159 (98.8%) |
Inquiry led to full data request, No. (%) | 31 (19.3%) |
Median number of days for response to inquiry (Interquartile Range) | 15 (7.5–41.5) |
Total unique trials requested within answered inquiries, No. | 207 |
Trial data can be made “available” to request, No. (%) | 124 (59.9%) |
Trial data cannot be made “available” to request, No. (%) | 83 (40.1%) |
Regulatory approval not yet received, No. (%) | 17 (20.5%) |
Trial ongoing or completed<18 months ago, No. (%) | 26 (31.3%) |
Data cannot be adequately de-identified, No. (%) | 0 (0%) |
Partner of Data Holder has not agreed to share, No. (%) | 11 (13.3%) |
Trial is out of scope (i.e., Phase 1, OTC, etc.), No. (%) | 25 (30.1%) |
Data subject to partner agreement; researcher advised to contact partnering Data Holder, No. (%) | 2 (2.4%) |
Data cannot be converted to electronic format, No. (%) | 1 (1.2%) |
Trial materials not available in English, No. (%) | 5 (6.0%) |
