@article{32be698db96042a1b6e72a0d51255ad9,
title = "The Master Observational Trial: A New Class of Master Protocol to Advance Precision Medicine",
abstract = "This commentary introduces a new clinical trial construct, the Master Observational Trial (MOT), which hybridizes the power of molecularly based master interventional protocols with the breadth of real-world data. The MOT provides a clinical venue to allow molecular medicine to rapidly advance, answers questions that traditional interventional trials generally do not address, and seamlessly integrates with interventional trials in both diagnostic and therapeutic arenas. The result is a more comprehensive data collection ecosystem in precision medicine.",
keywords = "ROOT, evidence, innovation, innovation, master, protocol, quality, real-world data, trial",
author = "Dane Dickson and Jennifer Johnson and Raymond Bergan and Rebecca Owens and Vivek Subbiah and Razelle Kurzrock",
note = "Funding Information: Special thanks to Spencer Strobel, M.D. for help in preparing the manuscript and Judy Taylor for assistance with graphics and Allison Taylor for copyediting. Conceptualization, D.D.; Methodology, D.D. J.J. R.B. R.K. R.O. and V.S.; Writing – Original Draft, D.D.; Writing – Review & Editing, D.D. J.J. R.B. R.K. R.O. and V.S.; Supervision, J.J. R.B. R.K. and V.S. D.D.: stock and other equity interests, cofounder, CEO, and shareholder of Taproot Health, who is the sponsor of ROOT; speaker's fee, Novartis. J.J.: consulting or advisory role, Foundation Medicine. R.B.: stock and other equity interests, co-owner of Third Coast Therapeutics, which has an option to license patents on which he is an inventor, and which relate to experimental drugs for the treatment of cancer. R.O.: stock and other equity interests, cofounder, CCO, and shareholder of Taproot Health, who is the sponsor of ROOT. V.S.: research funding/grant support for clinical trials: Novartis, Bayer, GlaxoSmithKline, Nanocarrier, Vegenics, Celgene, Northwest Biotherapeutics, Berghealth, Incyte, Fujifilm, Pharmamar, D3, Pfizer, Multivir, Amgen, Abbvie, Alfa-sigma, Agensys, Boston Biomedical, Idera Pharma, Inhibrx, Exelixis, Blueprint Medicines, Loxo Oncology, Medimmune, Altum, Dragonfly Therapeutics, Takeda and Roche/Genentech, National Comprehensive Cancer Network, NCI-CTEP, and UT MD Anderson Cancer Center. Travel: Novartis, Pharmamar, ASCO, ESMO, Helsinn, Incyte, US-FDA. Consultancy/advisory board: Helsinn, LOXO Oncology/Eli Lilly, R-Pharma US, INCYTE, Medimmune, Novartis. R.K.: stock and other equity interests, IDbyDNA, CureMatch, Inc. and Soluventis; consulting or advisory role, Gaido, LOXO, X-Biotech, Actuate Therapeutics, Roche, NeoMed, Soluventis, and Pfizer; speaker's fee, Roche; research funding, Incyte, Genentech, Merck Serono, Pfizer, Sequenom, Foundation Medicine, Guardant Health, Grifols, Konica Minolta, DeBiopharm, Boerhringer Ingelheim, and OmniSeq (all institutional); board member, CureMatch, Inc. J.J. R.B. R.K. and S.S. are principal investigators of the ROOT trial. These are uncompensated, volunteer roles. Funding Information: D.D.: stock and other equity interests, cofounder, CEO, and shareholder of Taproot Health, who is the sponsor of ROOT; speaker{\textquoteright}s fee, Novartis. J.J.: consulting or advisory role, Foundation Medicine. R.B.: stock and other equity interests, co-owner of Third Coast Therapeutics, which has an option to license patents on which he is an inventor, and which relate to experimental drugs for the treatment of cancer. R.O.: stock and other equity interests, cofounder, CCO, and shareholder of Taproot Health, who is the sponsor of ROOT. V.S.: research funding/grant support for clinical trials: Novartis, Bayer, GlaxoSmithKline, Nanocarrier, Vegenics, Celgene, Northwest Biotherapeutics, Berghealth, Incyte, Fujifilm, Pharmamar, D3, Pfizer, Multivir, Amgen, Abbvie, Alfa-sigma, Agensys, Boston Biomedical, Idera Pharma, Inhibrx, Exelixis, Blueprint Medicines, Loxo Oncology, Medimmune, Altum, Dragonfly Therapeutics, Takeda and Roche/Genentech, National Comprehensive Cancer Network, NCI-CTEP, and UT MD Anderson Cancer Center. Travel: Novartis, Pharmamar, ASCO, ESMO, Helsinn, Incyte, US-FDA. Consultancy/advisory board: Helsinn, LOXO Oncology/Eli Lilly, R-Pharma US, INCYTE, Medimmune, Novartis. R.K.: stock and other equity interests, IDbyDNA, CureMatch, Inc., and Soluventis; consulting or advisory role, Gaido, LOXO, X-Biotech, Actuate Therapeutics, Roche, NeoMed, Soluventis, and Pfizer; speaker{\textquoteright}s fee, Roche; research funding, Incyte, Genentech, Merck Serono, Pfizer, Sequenom, Foundation Medicine, Guardant Health, Grifols, Konica Minolta, DeBiopharm, Boerhringer Ingelheim, and OmniSeq (all institutional); board member, CureMatch, Inc. J.J., R.B., R.K., and S.S. are principal investigators of the ROOT trial. These are uncompensated, volunteer roles. Publisher Copyright: {\textcopyright} 2019 Elsevier Inc.",
year = "2020",
month = jan,
day = "9",
doi = "10.1016/j.cell.2019.12.009",
language = "English (US)",
volume = "180",
pages = "9--14",
journal = "Cell",
issn = "0092-8674",
publisher = "Cell Press",
number = "1",
}