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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)