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Table 1 Characteristics of included trials by anticancer drug type

From: Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation

 

ICPi (n = 3)

Other anticancer drug (n = 10)

Included drugs (n)

Ipilimumab, Pembrolizumab, Nivolumab

Abiraterone acetate, Brentuximab vedotin, Bosutinib, Ziv-aflibercept, Dabrafenib, Afatinib, Belinostat, Ramucirumab, Blinatumomab, Olaparib

Drug approval characteristics, n (%)

Priority review 0, orphan drug 3 (100%), breakthrough therapy 2 (67%), accelerated approval 2 (67%)

Priority review 4 (40%), orphan drug 7 (70%), breakthrough therapy 1 (10%), accelerated approval 4 (40%)

 

ICPi trials (n = 19)

Other anticancer drug trials (n = 101)

Study phase, n (%)

 Phase 1

5 (26)

42 (42)

 Phase 2

9 (47)

48 (48)

 Phase 3

5 (26)

11 (11)

Efficacy study, n (%)

11 (58)

18 (18)

Randomized study, n (%)

12 (63)

28 (28)

Double-blinded study, n (%)

7 (37)

13 (13)

Multi-country study, n (%)

12 (63)

52 (51)

Author affiliation with industry, n (%)

18 (95)

82 (81)

Sample size, median (IQR)

284 (127–676)

58 (37–121)

Statistically significant outcomeª, n (%)

8 (42)

10 (10)

Reporting of adverse events, n (%)

19 (100)

91 (90)

Selective outcome reporting, n (%)

6 (32)

21 (21)

  1. ICPi immune checkpoint inhibitor, IQR interquartile range
  2. ªAt least 1 of the primary outcomes was statistically significant