Selection Bias, Phase II Trials, and the FDA Accelerated Approval Process
نویسندگان
چکیده
منابع مشابه
Surrogate endpoints and FDA's accelerated approval process.
There is interest in approaches allowing more rapid availability of new interventions, particularly for diseases providing risks of death or serious illness. The accelerated-approval regulatory process is intended to address this need by allowing marketing of interventions shown to have strong effects on measures of biological activity, if those measures are potential "surrogates" for true meas...
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ژورنال
عنوان ژورنال: JNCI Journal of the National Cancer Institute
سال: 2003
ISSN: 0027-8874,1460-2105
DOI: 10.1093/jnci/djg070