Retrospective evaluation of single patient investigational new drug (IND) requests in pediatric oncology.

David S ShulmanLulla V KiwindaStacey EdwardsCatherine M ClintonSarah HuntLianne GreenspanKristen D LawlerGregory ReamanHasan Al-SayeghKira BonaAllison F O'NeillSuzanne ShustermanKatherine A JanewayAndrew E PlaceSusan N ChiClement MaSteven G DuBois

Published in: Cancer medicine (2021)

Single patient INDs in pediatric oncology were universally approved in our national and single-center analysis. In our cohort, single patient INDs were primarily utilized based on disease histology, rather than genomics, for agents that lacked a clinical trial.

Keyphrases

clinical trial
case report
palliative care
emergency department
single cell
cross sectional
open label
phase ii
study protocol
adverse drug
drug administration