TY - JOUR
T1 - Designing Dose-Optimization Studies in Cancer Drug Development
T2 - Discussions with Regulators
AU - Marchenko, Olga
AU - Sridhara, Rajeshwari
AU - Jiang, Qi
AU - Barksdale, Elizabeth
AU - Ando, Yuki
AU - Alwis, Dinesh De
AU - Brown, Katie
AU - Fernandes, Laura
AU - van Bussel, Mark T.J.
AU - Choo, Qiuyi
AU - Coory, Michael
AU - Garrett-Mayer, Elizabeth
AU - Gwise, Thomas
AU - Hess, Lorenzo
AU - Liu, Rong
AU - Mandrekar, Sumithra
AU - Ouellet, Daniele
AU - Pinheiro, José
AU - Posch, Martin
AU - Rahman, Nam Atiqur
AU - Rantell, Khadija Rerhou
AU - Raven, Andrew
AU - Sarem, Sarem
AU - Sen, Suman
AU - Shah, Mirat
AU - Shen, Yuan Li
AU - Simon, Richard
AU - Theoret, Marc
AU - Yuan, Ying
AU - Pazdur, Richard
N1 - Publisher Copyright:
© 2023 American Statistical Association.
PY - 2023
Y1 - 2023
N2 - The article provides a summary of discussions from the American Statistical Association (ASA) Biopharmaceutical (BIOP) Section Open Forums on March 18th, June 10th, and July 8th of 2021, organized by the ASA BIOP Statistical Methods in Oncology Scientific Working Group in coordination with the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence and the LUNGevity Foundation. Diverse stakeholders including oncologists, patient advocates, experts from regulatory agencies across the world, academicians, and representatives from the pharmaceutical industry engaged in a lively discussion on strategies for and designs of dose-optimization studies in cancer drug development. Dose-optimization is one of the major challenges in oncology drug development. The discussions were focused on considerations in designing dose-optimization studies of products for treatment of cancer patients in pre-approval and post-approval stages. Presenters and panelists discussed diverse ideas and methods and agreed that a shift in paradigm is required in oncology drug development that should improve dose optimization while not unnecessarily delaying patient access to potentially efficacious new treatments.
AB - The article provides a summary of discussions from the American Statistical Association (ASA) Biopharmaceutical (BIOP) Section Open Forums on March 18th, June 10th, and July 8th of 2021, organized by the ASA BIOP Statistical Methods in Oncology Scientific Working Group in coordination with the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence and the LUNGevity Foundation. Diverse stakeholders including oncologists, patient advocates, experts from regulatory agencies across the world, academicians, and representatives from the pharmaceutical industry engaged in a lively discussion on strategies for and designs of dose-optimization studies in cancer drug development. Dose-optimization is one of the major challenges in oncology drug development. The discussions were focused on considerations in designing dose-optimization studies of products for treatment of cancer patients in pre-approval and post-approval stages. Presenters and panelists discussed diverse ideas and methods and agreed that a shift in paradigm is required in oncology drug development that should improve dose optimization while not unnecessarily delaying patient access to potentially efficacious new treatments.
KW - DLT
KW - Dose-optimization
KW - MTD
KW - Oncology drug development
UR - http://www.scopus.com/inward/record.url?scp=85148429257&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85148429257&partnerID=8YFLogxK
U2 - 10.1080/19466315.2023.2166099
DO - 10.1080/19466315.2023.2166099
M3 - Letter
AN - SCOPUS:85148429257
SN - 1946-6315
VL - 15
SP - 697
EP - 703
JO - Statistics in Biopharmaceutical Research
JF - Statistics in Biopharmaceutical Research
IS - 3
ER -