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While the FDA is working on at least five new guidances to promote adaptive clinical trials, experts cannot seem to agree on what precisely the term means.
The FDA has partially lifted the clinical hold it imposed March 29 on Corautus Genetics’ GENASIS Phase IIb clinical trial of its VEGF-2 therapy for cardiovascular disease and peripheral vascular disease.
Sponsors, sites and clinical investigators must all confront the rapid proliferation of grounds for criminal and civil cases
against them, experts said at a recent industry conference.
Clinical investigators are key to the success of any clinical trial, yet many sponsors are not thinking through the best ways of recruiting and retaining them, according to a survey of 18 sponsors, seven clinical research organizations and 20 sites.
A new study finds that potential volunteers for clinical trials have more complicated motives for participating than such conventionally mentioned reasons as money, altruism and the desire for medical treatment.