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Successful trial outcomes – peering into the crystal ball


With rising trial costs and shrinking budgets, pharma companies are working more diligently than ever to identify keys to success in the clinic. But without the benefit of the proverbial crystal ball, the industry must rely on examining historical records as predictors or benchmarks of future performance. Susan Danheiser and the Citeline Analytics team begin to explore this notion, and outline key findings from a retrospective analysis of clinical trial outcomes in six therapeutic areas.


Using a new feature of Citeline’s TrialTrove database that assesses and tracks trial outcomes, we have analysed completed trials with positive outcomes (primary endpoint(s) met), negative outcomes (primary endpoint(s) missed), or outcomes that could not be definitively determined (indeterminate). Trials that terminated due to early positive or negative outcomes or other reasons are tracked as well, but not covered here.

Our analysis includes industry sponsored trials, covering Phases I/II, II, II/III and III, for which primary endpoint results were reported in public domain sources and captured in TrialTrove during a one-year period, from 1 September 2010 to 31 August 2011 (NB: many of the trials may have completed prior to this period). The data were accessed by the team on 19 September 2011. Outcomes are evaluated by trial phase, disease type and sponsor, and in six therapeutic areas – autoimmune/inflamation, cardiovascular, central nervous system (CNS), infectious disease, metabolic/endocrinology and oncology.

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