RT Journal Article
SR Electronic
T1 Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume II—practical challenges
JF Journal for ImmunoTherapy of Cancer
JO J Immunother Cancer
FD BMJ Publishing Group Ltd
SP e001472
DO 10.1136/jitc-2020-001472
VO 8
IS 2
A1 Alessandra Cesano
A1 Michael A Cannarile
A1 Sacha Gnjatic
A1 Bruno Gomes
A1 Justin Guinney
A1 Vaios Karanikas
A1 Mohan Karkada
A1 John M Kirkwood
A1 Beatrix Kotlan
A1 Giuseppe V Masucci
A1 Els Meeusen
A1 Anne Monette
A1 Aung Naing
A1 Vésteinn Thorsson
A1 Nicholas Tschernia
A1 Ena Wang
A1 Daniel K Wells
A1 Timothy L Wyant
A1 Sergio Rutella
YR 2020
UL http://jitc.bmj.com/content/8/2/e001472.abstract
AB The development of strongly predictive validated biomarkers is essential for the field of immuno-oncology (IO) to advance. The highly complex, multifactorial data sets required to develop these biomarkers necessitate effective, responsible data-sharing efforts in order to maximize the scientific knowledge and utility gained from their collection. While the sharing of clinical- and safety-related trial data has already been streamlined to a large extent, the sharing of biomarker-aimed clinical trial derived data and data sets has been met with a number of hurdles that have impaired the progression of biomarkers from hypothesis to clinical use. These hurdles include technical challenges associated with the infrastructure, technology, workforce, and sustainability required for clinical biomarker data sharing. To provide guidance and assist in the navigation of these challenges, the Society for Immunotherapy of Cancer (SITC) Biomarkers Committee convened to outline the challenges that researchers currently face, both at the conceptual level (Volume I) and at the technical level (Volume II). The committee also suggests possible solutions to these problems in the form of professional standards and harmonized requirements for data sharing, assisting in continued progress toward effective, clinically relevant biomarkers in the IO setting.