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Table 4 Study characteristics of 42 clinical trials registered on ClinicalTrials.gov based on ClinicalTrials.gov data

From: Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

Characteristics

No. (%) or median (IQR)

New clinical trial

N = 28

Complete or submit results from ongoing clinical trials

N = 16

Randomization

 Yes

26 (92.9)

10 (62.5)

 No

2 (7.1)

6 (37.5)

Allocation

 Double blind

22 (78.6)

6 (37.6)

 Open label

6 (21.4%)

10 (62.5)

Comparator

 Placebo

18 (64.3)

6 (37.5)

 Active

4 (14.3)

4 (25.0)

 None

6 (21.4)

6 (37.5)

Endpoint

 Surrogate outcome

6 (21.4)

10 (62.5)

 Clinical outcome

5 (17.9)

3 (18.8)

 Clinical scale

17 (60.7)

0 (0.0)

 Safety

0 (0.0)

3 (18.8)

Estimated sample size

400 (254 to 529)

237 (373 to 744)

Duration (months)

1.6 (0.9 to 12.0)

5.6 (5.2 to 12.6)