PT  - JOURNAL ARTICLE
AU  - Alessandra Cesano
AU  - Michael A Cannarile
AU  - Sacha Gnjatic
AU  - Bruno Gomes
AU  - Justin Guinney
AU  - Vaios Karanikas
AU  - Mohan Karkada
AU  - John M Kirkwood
AU  - Beatrix Kotlan
AU  - Giuseppe V Masucci
AU  - Els Meeusen
AU  - Anne Monette
AU  - Aung Naing
AU  - Vésteinn Thorsson
AU  - Nicholas Tschernia
AU  - Ena Wang
AU  - Daniel K Wells
AU  - Timothy L Wyant
AU  - Sergio Rutella
TI  - Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume II—practical challenges
AID  - 10.1136/jitc-2020-001472
DP  - 2020 Dec 01
TA  - Journal for ImmunoTherapy of Cancer
PG  - e001472
VI  - 8
IP  - 2
4099  - http://jitc.bmj.com/content/8/2/e001472.short
4100  - http://jitc.bmj.com/content/8/2/e001472.full
SO  - J Immunother Cancer2020 Dec 01; 8
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.