On May 12-16, FDA carried out a five-day inspection of a PUMCH’s international clinical trial named “multi-center, random and blind trial on the safety and efficacy of long-acting pasireotide and long-acting octreotide on acromegaly at active stage”.
358 cases from 126 research centers from 30 countries were randomly selected, including 33 cases from PUMCH, being the center of most cases. PUMCH thus received the attention of FDA. The trial has been lasting for five years since the department of endocrinology entered the first case in March 2009 and presently there are still nine cases under extended treatment and safety observation.
FDA inspectors checked the project in a comprehensive, strict manner, combing through details throughout the course, and highly praised its overall quality.