TY - JOUR
T1 - Cancer Clinical Trials beyond Pandemic
T2 - Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion
AU - Sridhara, Rajeshwari
AU - Barksdale, Elizabeth
AU - Marchenko, Olga
AU - Jiang, Qi
AU - Ando, Yuki
AU - Bloomquist, Erick
AU - Coory, Michael
AU - Crouse, Melissa
AU - Degtyarev, Evgeny
AU - Framke, Theodor
AU - Freidlin, Boris
AU - Gerber, David E.
AU - Gwise, Thomas
AU - Josephson, Filip
AU - Hess, Lorenzo
AU - Kluetz, Paul
AU - Li, Daniel
AU - Mandrekar, Sumithra
AU - Posch, Martin
AU - Rantell, Khadija
AU - Ratitch, Bohdana
AU - Raven, Andrew
AU - Roes, Kit
AU - Rufibach, Kaspar
AU - Sarac, Sinan B.
AU - Simon, Richard
AU - Singh, Harpreet
AU - Theoret, Marc
AU - Thomson, Andrew
AU - Zuber, Emmanuel
AU - Shen, Yuan Li
AU - Pazdur, Richard
N1 - Funding Information:
Martin Posch is a member of the EU Patient-centric clinical trial platform (EU-PEARL). EU-PEARL has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement N
Funding Information:
853966. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and Children’s Tumor Foundation, Global Alliance for TB Drug Development nonprofit organization, Springworks Therapeutics Inc. This publication reflects the authors’ views. Neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein.
Publisher Copyright:
© 2022 American Statistical Association.
PY - 2022
Y1 - 2022
N2 - This article provides a summary of discussions from the American Statistical Association (ASA) Biopharmaceutical (BIOP) Section Open Forum organized by the ASA BIOP Statistical Methods in Oncology Scientific Working Group in coordination with the US FDA Oncology Center of Excellence and LUNGevity Foundation on January 14, 2021, and February 8, 2021. Diverse stakeholders including oncologists, patient advocates, experts from international regulatory agencies, academicians, and representatives of the pharmaceutical industry engaged in a discussion on how best to incorporate lessons learned during the COVID-19 pandemic into the design of future oncology trials. While recognizing that decentralized or hybrid cancer trials may increase variability associated with measurement error and potentially increase bias in treatment effect estimation, panel discussions highlighted the importance of flexibility for decreasing patient burden, which has the potential to increase access to and retention in cancer clinical trials and may broaden the representation of real-world patients in the trial setting.
AB - This article provides a summary of discussions from the American Statistical Association (ASA) Biopharmaceutical (BIOP) Section Open Forum organized by the ASA BIOP Statistical Methods in Oncology Scientific Working Group in coordination with the US FDA Oncology Center of Excellence and LUNGevity Foundation on January 14, 2021, and February 8, 2021. Diverse stakeholders including oncologists, patient advocates, experts from international regulatory agencies, academicians, and representatives of the pharmaceutical industry engaged in a discussion on how best to incorporate lessons learned during the COVID-19 pandemic into the design of future oncology trials. While recognizing that decentralized or hybrid cancer trials may increase variability associated with measurement error and potentially increase bias in treatment effect estimation, panel discussions highlighted the importance of flexibility for decreasing patient burden, which has the potential to increase access to and retention in cancer clinical trials and may broaden the representation of real-world patients in the trial setting.
KW - COVID-19 pandemic
KW - Decentralized trials
KW - Oncology drug development
KW - Telemedicine
UR - http://www.scopus.com/inward/record.url?scp=85139169257&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85139169257&partnerID=8YFLogxK
U2 - 10.1080/19466315.2022.2103181
DO - 10.1080/19466315.2022.2103181
M3 - Letter
AN - SCOPUS:85139169257
SN - 1946-6315
JO - Statistics in Biopharmaceutical Research
JF - Statistics in Biopharmaceutical Research
ER -