Phase 0 clinical trials
In a move to speed the development of new medicines, the US Food and Drug Administration announced in January the creation of so-called phase 0, or exploratory, clinical trials. The new rules were developed in response to a 2004 report that urged the agency to overhaul the national clinical trials system. The new rules define an exploratory clinical trial as one conducted before traditional dose escalation and safety studies. Generally limited to seven days or less, the trials are designed to generate crucial data on biological actions in the human body and to flag any obvious adverse reactions. In a statement to the FDA, Jim Geenwood, president and CEO of the Biotechnology Industry Organization in Washington, DC, lauds the new rules, saying they will help “get the right medicine to the right patient, at the right time and in the right dosage.” Janet Woodcock, deputy commissioner for operations at the FDA, notes the new regulations are tailored for academic laboratories and small companies that want to manufacture first batches of experimental drugs and biologics. “The problem was that researchers conducting very early studies were required to follow the same manufacturing procedures as [required for] broad-scale distribution.” BV
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