N-of-1 Trials in Cancer Drug Development.

Autor: Gouda MA; Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas., Buschhorn L; Division of Gynecological Oncology, National Center for Tumor Diseases (NCT), Heidelberg, Germany., Schneeweiss A; Division of Gynecological Oncology, National Center for Tumor Diseases (NCT), Heidelberg, Germany., Wahida A; Division of Gynecological Oncology, National Center for Tumor Diseases (NCT), Heidelberg, Germany., Subbiah V; Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.; Division of Pediatrics, The University of Texas MD Anderson Cancer Center, Houston, Texas.; MD Anderson Cancer Network, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Jazyk: angličtina
Zdroj: Cancer discovery [Cancer Discov] 2023 Jun 02; Vol. 13 (6), pp. 1301-1309.
DOI: 10.1158/2159-8290.CD-22-1377
Abstrakt: Summary: The current approaches for cancer drug development lag behind an accelerated need in the field for a fast and efficient method for evaluating drugs in the personalized medicine era. In that regard, N-of-1 studies emerge as a potential addition to the drug development arsenal, although there are several considerations before its broad application becomes feasible. In essence, N-of-1 trials are a departure from the traditional "drug-centric" model to a "patient-centric" model. Herein, we review the concept of N-of-1 trials and provide real-world examples of their use in the developmental therapeutics field. N-of-1 trials offer an exceptional opportunity for fast-tracking of cancer drug development in the precision oncology era.
(©2023 The Authors; Published by the American Association for Cancer Research.)
Databáze: MEDLINE