TY - JOUR
T1 - Light and shadow on innovative clinical trial designs
T2 - reflections from the EORTC-PAMM course on ‘preclinical and early-phase clinical pharmacology’
AU - on Behalf of the EORTC PAMM Group
AU - Leonetti, Alessandro
AU - Boyd, Lenka
AU - Giuliani, Jacopo
AU - Giovannetti, Elisa
AU - Garajová, Ingrid
PY - 2019/11/2
Y1 - 2019/11/2
N2 - Introduction: In the era of ‘precision’ oncology, novel clinical trial designs have emerged, in order to better address the final goal of translating the above-mentioned preclinical discoveries into the clinic. Nonetheless, in aiming to achieve the greatest clinical benefit to patients, some limitations of these novel approaches from the statistical, methodological and practical point of view need to be overcome. Areas covered: In the present review, a short overview of basket trials, umbrella trials and platform trials are discussed, in particular advantages and disadvantages of such experimental approaches. Expert opinion: Master protocols represent the future of clinical oncology research. The possibility of investigating multiple biomarkers and therapeutic regimens under one study is a strong advantage over traditional trials, and it can lead to quick implementation of new, promising treatments or biomarkers into the clinic.
AB - Introduction: In the era of ‘precision’ oncology, novel clinical trial designs have emerged, in order to better address the final goal of translating the above-mentioned preclinical discoveries into the clinic. Nonetheless, in aiming to achieve the greatest clinical benefit to patients, some limitations of these novel approaches from the statistical, methodological and practical point of view need to be overcome. Areas covered: In the present review, a short overview of basket trials, umbrella trials and platform trials are discussed, in particular advantages and disadvantages of such experimental approaches. Expert opinion: Master protocols represent the future of clinical oncology research. The possibility of investigating multiple biomarkers and therapeutic regimens under one study is a strong advantage over traditional trials, and it can lead to quick implementation of new, promising treatments or biomarkers into the clinic.
KW - Clinical trial
KW - basket trial
KW - precision oncology
KW - umbrella trial
UR - http://www.scopus.com/inward/record.url?scp=85074269978&partnerID=8YFLogxK
U2 - https://doi.org/10.1080/17512433.2019.1683446
DO - https://doi.org/10.1080/17512433.2019.1683446
M3 - Review article
C2 - 31633383
SN - 1751-2433
VL - 12
SP - 1033
EP - 1036
JO - Expert Review of Clinical Pharmacology
JF - Expert Review of Clinical Pharmacology
IS - 11
ER -