External Control Arms: Better Than Single-Arm Studies But No Replacement For Randomization
Synthetic control group derived from historical clinical trial data could augment smaller randomized trials and yield better information than single-arm studies, but this approach should not be viewed as a substitute for randomized trials where feasible, US FDA officials said at a Friends of Cancer Research meeting.
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Agency’s approach to assessing real-world evidence for effectiveness will be guided by three key principles: fitness for use of the underlying data, adequacy of the study design, and satisfactory monitoring and data collection.
COVID-19 Vaccines: ACIP’s Allocation Proposal Prioritizes Long-Term Care Residents, Essential Workers
First group to receive vaccine would comprise health care personnel and residents of long-term care facilities; next in line are non-health care essential workers, who would take priority over adults with high-risk medical conditions and those ages 65 years and older, according to the CDC advisory committee’s proposed allocation framework.
Although US FDA wants sponsors to maintain blinded Phase III follow-up as long as possible after emergency use authorization or licensure, vaccine researcher Larry Corey says it will become ‘untenable’ to keep individuals in placebo arm once they qualify for vaccine access under the allocation framework.