TY - CHAP
T1 - Pragmatic solutions for optimizing oncology drug development trials
AU - Verweij, Jaap
AU - Longson, Carole
AU - von Lilienfeld-Toal, Marie
AU - Cahane, David
AU - Jeffry Evans, Thomas R.
AU - Chiou, Victoria L.
AU - Lacombe, Denis
AU - Gravis, Gwenaelle
AU - Goldstein, Daniel A.
N1 - Publisher Copyright:
© 2023 Elsevier Inc. All rights reserved.
PY - 2023/1/1
Y1 - 2023/1/1
N2 - Practical strategies are needed for strengthening the development of cancer drugs, focusing on optimization of treatment dosage, and improvements in the diversity of patients enrolled in clinical trials. Treatment optimization (both pre- and post-marketing) offers potential to deliver a range of benefits including a reduction in the burden of side-effects to patients and cost of drugs to health care systems. For immune checkpoint inhibitors (ICIs), dosage optimization involves reducing duration of treatment, extending interval administration, and a ‘stop and go’ approach where treatment is resumed if patients progress. Such initiatives will be necessary to optimize effectiveness and achieve the economic savings needed for global access to these drugs. Strategies are needed to increase patient diversity so that clinical trials start to represent the patient groups the interventions being studied intend to treat. The potential of decentralized trials is explored in greater depth as one of the ways to increase clinical trial diversity.
AB - Practical strategies are needed for strengthening the development of cancer drugs, focusing on optimization of treatment dosage, and improvements in the diversity of patients enrolled in clinical trials. Treatment optimization (both pre- and post-marketing) offers potential to deliver a range of benefits including a reduction in the burden of side-effects to patients and cost of drugs to health care systems. For immune checkpoint inhibitors (ICIs), dosage optimization involves reducing duration of treatment, extending interval administration, and a ‘stop and go’ approach where treatment is resumed if patients progress. Such initiatives will be necessary to optimize effectiveness and achieve the economic savings needed for global access to these drugs. Strategies are needed to increase patient diversity so that clinical trials start to represent the patient groups the interventions being studied intend to treat. The potential of decentralized trials is explored in greater depth as one of the ways to increase clinical trial diversity.
KW - Decentralized trial
KW - Dose optimization
KW - Dose refinement
KW - Trial population diversity
UR - http://www.scopus.com/inward/record.url?scp=85191909887&partnerID=8YFLogxK
U2 - 10.1016/B978-0-12-824010-6.00054-X
DO - 10.1016/B978-0-12-824010-6.00054-X
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AN - SCOPUS:85191909887
VL - 1-2
SP - V2-293-V2-303
BT - Comprehensive Precision Medicine, First Edition, Volume 1-2
PB - Elsevier
ER -
