TY - JOUR T1 - Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I—conceptual challenges JF - Journal for ImmunoTherapy of Cancer JO - J Immunother Cancer DO - 10.1136/jitc-2020-001389 VL - 8 IS - 2 SP - e001389 AU - Sergio Rutella 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 - Alessandra Cesano Y1 - 2020/10/01 UR - http://jitc.bmj.com/content/8/2/e001389.abstract N2 - The sharing of clinical trial data and biomarker data sets among the scientific community, whether the data originates from pharmaceutical companies or academic institutions, is of critical importance to enable the development of new and improved cancer immunotherapy modalities. Through data sharing, a better understanding of current therapies in terms of their efficacy, safety and biomarker data profiles can be achieved. However, the sharing of these data sets involves a number of stakeholder groups including patients, researchers, private industry, scientific journals and professional societies. Each of these stakeholder groups has differing interests in the use and sharing of clinical trial and biomarker data, and the conflicts caused by these differing interests represent significant obstacles to effective, widespread sharing of data. Thus, the Society for Immunotherapy of Cancer (SITC) Biomarkers Committee convened to identify the current barriers to biomarker data sharing in immuno-oncology (IO) and to help in establishing professional standards for the responsible sharing of clinical trial data. The conclusions of the committee are described in two position papers: Volume I—conceptual challenges and Volume II—practical challenges, the first of which is presented in this manuscript. Additionally, the committee suggests actions by key stakeholders in the field (including organizations and professional societies) as the best path forward, encouraging the cultural shift needed to ensure responsible data sharing in the IO research setting. ER -