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 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 |
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