IQVIA informs of an important trends in clinical research and drug approvals. Between 2005 and 2012, out of the 188 novel therapeutic agents approved by the FDA, 74 (36.8%) were approved on the basis of a single pivotal clinical trial. The report titled “The Changing Landscape of Research and Development” evidences what we at TrialSite News have been observing for quite a while—a transforming drug development sector. 42% of novel drugs approved in 2018 were approved on the basis of only one clinical trial! The implications are considerable from costs to returns to patient choice to profit margins.
One out of 8 approvals relied on Phase 1 or 2 trials with no Phase 3 studies at all. The studies relying on just one trial were primarily new orphan and cancer drugs—classes of treatments that can represent significant return on investment.
The IQVIA report summarizes some of the transforming elements clinical research. Back in 1997 the FDA changed the requirements allowing more flexibility with passage of the Food and Drug Administration Modernization Act.
In 2018, 59 new active substances (NAS) were launched—the highest in five years. Of this total, 12 were medicines that stratif...
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