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

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
  1. Data specified as number of trials (% of the total number of trials assessed by global sales status)
  2. 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
  3. 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)
  4. cNo specific data sharing enquiry contact/process identified