Changes in trial design after the onset of patient accrual can affect the scientific basis of evidence-based medicine and should be reported and justified.1 Data on the prevalence of these changes in oncology drug development are scarce. We aimed to quantify these changes in trials that supported cancer drug approval by the US Food and Drug Administration (FDA) and to explore the associations of such changes with study characteristics and drug-approval processes.
Shepshelovich D, Tibau A, Molto C, et al. Assessment of Frequency and Reporting of Changes in Cancer Trial Design After Initiation of Patient Accrual. JAMA Oncol. Published online December 06, 2018. doi:10.1001/jamaoncol.2018.5877
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