Industry Ranks Well On Pediatric Trial Completion But Not Publication
Compared to academic-funded pediatric studies, industry-backed studies more likely to be completed, Boston researchers conclude.
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FDA says compliance is on par with other postmarketing requirements, but jury is still out on whether public posting of noncompliance letters has been effective tool to ensure timely trial completion.
Real-World Evidence: CDC Prioritizing Populations, Outcomes For COVID-19 Vaccine Effectiveness Studies
Strategy for assessing how the earliest vaccines to reach market perform beyond clinical trials includes leveraging existing surveillance and data platforms, and employing a diversity of study approaches, CDC epidemiologist says; high-priority areas for study include protection against symptomatic illness among health care workers and prevention of severe disease in the elderly.
Biologics license application is preferred route to market, but if emergency authorization is given it should happen with full transparency and be communicated in a clear manner to strengthen public confidence, National Vaccine Advisory Committee says.