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Objectives To define characteristics of orphan cancer drugs and their pivotal clinical trials and to compare these with nonorphan drugs.
.......More treated patients had serious adverse events in trials of orphan drugs vs trials of nonorphan drugs (48% vs 36%; odds ratio, 1.72; 95% confidence interval, 1.02-2.92; P = .04).
Conclusion Compared with
pivotal trials used to approve nonorphan cancer drugs, pivotal trials
for recently approved orphan drugs for
cancer were more likely to be smaller and to use
nonrandomized, unblinded trial designs and surrogate end points to
assess
efficacy.
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