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Table 3 Registration, results reporting, and publication of postmarketing commitments of new drugs and biologics approved by the Food and Drug Administration between 2009 and 2012

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

Category

No. (%)

Registration

Results reporting

Results reporting or peer-reviewed publication

Eligible for registration at ClinicalTrials.gov

Registered

Eligible for results reportinga

Results reported

Eligible for publicationb

Published

Results reported or published

New clinical trials

31

28 (90.3)

23

22 (95.7)

29

14 (48.3)

22 (75.9)

Complete or submit results from ongoing clinical trials

16

16 (100.0)

15

15 (100.0)

15

14 (93.3)

15 (100.0)

Total

47

44 (93.6)

38

36 (94.7)

44

28 (63.6)

37 (84.1)

  1. aClinical studies classified as Completed or Terminated by ClinicalTrials.gov. The final rule requires the submission of results information no later than 1 year after the primary completion date
  2. bWe searched for publications for clinical trials classified by ClinicalTrials.gov as Completed or Terminated and by the FDA as Submitted, Fulfilled, Released, or unclear (e.g., last available record: 2013, ongoing)