From: Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability
Reason | Within top 25 by global sales (n = 35) | Below top 25 by global sales (n = 26) |
---|---|---|
Confirmed data sharing not available | 17 (49%) | 9 (35%) |
• Sponsor does not share IPD | 8 (23%) | 7 (27%) |
• Study is still ongoing | 5 (14%) | 0 |
• Medicine not approved by both EMA and FDA, or ongoing regulatory submission | 4 (11%) | 1 (4%) |
• Medicine no longer in development | 0 | 1 (4%) |
Unable to confirm eligibility/ineligibility | 10 (29%) | 16 (62%) |
• No response within 3 months to specified data sharing enquiry processa,b | 6 (17%) | 4 (15%) |
• No response within 3 months to generic sponsor contactc | 0 | 12 (46%) |
• Full research proposal required to assess eligibility | 4 (11%) | 0 |