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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)