Compliance on Mandatory Data Reporting in Registered Obstetrics Trials

Abstract

Background The Food and Drug Administration's (FDA's) Amendments Act established a legal mandate requiring registration of certain drug, device, and biologics trials in ClinicalTrials.gov prior to patient enrollment. One provision of the act requires investigators to report trial results in ClinicalTrials.gov within 1 year of completion. Preliminary evidence suggests that overall compliance rates are inadequate, and rates specific to obstetrics have not been investigated.

Objective The purpose of this study was to examine the rate of compliance for mandatory reporting of results from obstetrics trials to ClinicalTrials.gov and to determine whether compliance rates were associated with funding type.

Study Design We performed a registry-based study of clinical trials pertaining to obstetrics. ClinicalTrials.gov was cross-referenced with Drugs@FDA to determine which trials required mandatory reporting. We used obstetrics trials registered on ClinicalTrials.gov with at least 1 US site. Phase 0, Phase 1, and trials not reporting a phase were excluded. Furthermore, only trials of interventions approved by the FDA were retained.

Results Our search returned 973 trials, of which 325 (33.4%) were screened for eligibility. Of the 325 completed trials, 74 (22.8% or 7.6% of the total) met all inclusion criteria and were evaluated for compliance. Thirty-seven of these trials (50%) did not list results, whereas the remaining 37 trials (50%) contained results on ClinicalTrials.gov. Trials funded by the National Institutes of Health (87.5%; ⅞) and industry (80%; 12/15) had higher rates of compliance than trials funded by other (43.9%; 18/41) or unspecified (0%; 0/10) sources.

Conclusion Half of all applicable obstetrics trials did not report results. Furthermore, rates of compliance appeared to vary by funding source, with trials funded by the National Institutes of Health or industry appearing to have a higher rate of compliance to mandatory data reporting. Greater awareness of federal regulations is needed, and changes should be implemented to increase reporting.

Keywords

antenatal - clinical trials - ClinicalTrials.gov - data reporting - fetal - intrapartum - obstetrics - postpartum - prenatal - pregnancy

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