RT Journal Article
SR Electronic
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
FD BMJ Publishing Group Ltd
SP e001389
DO 10.1136/jitc-2020-001389
VO 8
IS 2
A1 Sergio Rutella
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 Alessandra Cesano
YR 2020
UL http://jitc.bmj.com/content/8/2/e001389.abstract
AB 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.