Trial Registrations Steady, Uptick Expected

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Registrations of new clinical trials hewed to recent trends in 2015, with nearly 4,600 new Phase I-III trials registered in clinicaltrials.gov (see figure below). Phase I trial registrations dropped to 1,789 from 2014’s 2,366, but the number of 2014 Phase I registrations was far above average for the previous 2008-2013 period, for unknown reasons. The number of Phase I registrations in 2015 was much more in line with the longer-term trend.

Phase II clinical trial registrations seem to have stabilized after a sharp drop in 2013 was followed by a spike in 2014. The 1,696 Phase II registrations in 2015 was on par with the 2014 number. Phase III registrations continued the slow downward trajectory they have been on since 2009. That decline is to be expected as most programs halted when the financial crisis hit in 2007-2008 would just now be entering late development.

Forecasting the outlook for trial registrations is tricky. Registration in clinical trials.gov is meant to cover all drugs intended to be filed as NDAs or BLAs, but Phase I trials are not required to be registered, so the number of ongoing Phase I trials may be understated. Bio/pharma companies have generally been willing to register their Phase I studies on a voluntary basis, but it isn’t required.

This article is reprinted from the February issue of Biopharmaceutical Outsourcing Report. The full article addresses the future of additional funding and clinical trials. To learn more, click here.

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Jim Miller is the founder and president of PharmSource Information Services, Inc. A preeminent expert in bio/pharmaceutical outsourcing, Jim established and presides over the industry’s principal resource for serious consumers of information on contract drug development and manufacturing, PharmSource STRATEGIC ADVANTAGE. He is editor and publisher of Bio/Pharmaceutical Outsourcing Report and Emerging Markets Outsourcing Report.

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