Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability

Table 1 Breakdown of clinical trials for which eligibility for data sharing was not confirmed by global sales of sponsoring pharmaceutical company

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 process^a,b	6 (17%)	4 (15%)
• No response within 3 months to generic sponsor contact^c	0	12 (46%)
• Full research proposal required to assess eligibility	4 (11%)	0

Data specified as number of trials (% of the total number of trials assessed by global sales status)
^aOne clinical trial (conducted by a company below the top 25 by global sales) was confirmed as ineligible for data sharing after the 3-month enquiry period had expired (confirmed 5 months after initial enquiry) on the basis that the trial was still ongoing
^bTwo clinical trials (one conducted by a company within, and one conducted by a company below the top 25 by global sales) were confirmed eligible for data sharing after the 3-month enquiry period had expired (confirmed 5.3 and 6.6 months after initial enquiry)
^cNo specific data sharing enquiry contact/process identified

ISSN: 1741-7015