Celiac.com 04/18/2015 - Research is underway on a number of new drugs intended to celiac disease treatment beyond a simple gluten-free diet. However, even though several drugs are in Phase 2 trials and results appear promising, discussion around regulatory endpoints is just beginning.
A research team recently reviewed endpoints for Phase 2 and 3 trials of new celiac disease drugs currently under development, and detailed their results in a scientific paper. The team included Klaus Gottlieb, Jill Dawson, Fez Hussain and Joseph A. Murray. They are variously affiliated with the department of Immunology and Internal Medicine of Medical Strategy & Science, Quintiles, Durham, NC, USA, with Corporate Communications, Quintiles, Durham, NC, USA, and with the Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
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In the paper, the team discusses celiac drugs currently under development, along with trial endpoints, such as patient-reported outcomes, histology, serology, gene expression analysis and other tests.
They outline the differing requirements for proof-of-concept Phase 2 trials and Phase 3 registration trials, with a particular emphasis on current thinking in regulatory agencies. They conclude their paper with recommendations and a glossary of regulatory terms, to enable readers who are less familiar with regulatory language to take maximum advantage of this review.
Stay tuned for more news and information on all developments concerning trials of new celiac drug treatments.
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