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
| 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) |
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
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)