TY - JOUR
T1 - Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document
T2 - Volume II - Practical challenges
AU - Cesano, Alessandra
AU - Cannarile, Michael A.
AU - Gnjatic, Sacha
AU - Gomes, Bruno
AU - Guinney, Justin
AU - Karanikas, Vaios
AU - Karkada, Mohan
AU - Kirkwood, John M.
AU - Kotlan, Beatrix
AU - Masucci, Giuseppe V.
AU - Meeusen, Els
AU - Monette, Anne
AU - Naing, Aung
AU - Thorsson, Vésteinn
AU - Tschernia, Nicholas
AU - Wang, Ena
AU - Wells, Daniel K.
AU - Wyant, Timothy L.
AU - Rutella, Sergio
N1 - Funding Information:
Competing interests AC—Employee: ESSA Pharma; Consulting fees: Refuge Bio, Arch Oncology, Qognit, Nanostring. MAC—Employee: Roche Diagnostic GMBH; Stakeholder: Roche; Patent: 10878NDR. SG—Consultancy/advisory fees: Merck, NeonTherapeutics, OncoMed; Research funding: Agenus, Bristol-Myers Squibb, Genentech, Immune Design, Janssen R&D, Pfizer, Regeneron, Takeda. BG—Employee: Hoffmann La Roche; Stockholder: Roche. VK—Employee: Hoffmann La Roche; Stockholder: Roche; Patent: EP3221355A1. JMK—Grant funding: Prometheus, Merck; Personal fees: Array Biopharma, Bristol-Myers Squibb, Novartis, Roche; Grants and personal fees: Immunocore. EM—Director/shareholder: CancerProbe Pty Ltd. AN—Consulting fees: CytomX Therapeutics, Novartis, Kymab, Genome; Contracted research: National Cancer Institute, EMD Serono, MedImmune, Healios Onc. Nutrition, Atterocor, Amplimmune, ARMO Biosciences, Eli Lilly, Karyopharm Therapeutics, Incyte, Novartis, Regeneron, Merck, Bristol-Myers Squibb, Pfizer, CytomX Therapeutics, Neon Therapeutics, Calithera Biosciences, TopAlliance Biosciences, Kymab, PsiOxus; Travel accommodation: ARMO Biosciences; Partner contracted research: Immune Deficiency Foundation. DKW— Scientific co-founder, equity holder, and paid advisor: Immunai. TLW—Employee/ stockholder: Biolojic Design. JG, MK, BK, GVM, AM, SR, VT, NT, and EW—Nothing to disclose. SITC Staff: AK, BL, LL, and SMW—Nothing to disclose.
Publisher Copyright:
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2020/12/15
Y1 - 2020/12/15
N2 - 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.
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.
KW - immunotherapy
KW - tumor biomarkers
UR - http://www.scopus.com/inward/record.url?scp=85097909497&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85097909497&partnerID=8YFLogxK
U2 - 10.1136/jitc-2020-001472
DO - 10.1136/jitc-2020-001472
M3 - Article
C2 - 33323463
AN - SCOPUS:85097909497
SN - 2051-1426
VL - 8
JO - Journal for immunotherapy of cancer
JF - Journal for immunotherapy of cancer
IS - 2
M1 - e001472
ER -