Literature DB >> 31951522

The Master Observational Trial: A New Class of Master Protocol to Advance Precision Medicine.

Dane Dickson1, Jennifer Johnson2, Raymond Bergan3, Rebecca Owens4, Vivek Subbiah5, Razelle Kurzrock6.   

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.
Copyright © 2019 Elsevier Inc. All rights reserved.

Keywords:  ROOT; evidence; innovation; master; protocol; quality; real-world data; trial

Year:  2020        PMID： 31951522     DOI： 10.1016/j.cell.2019.12.009

Source DB:  PubMed          Journal:  Cell        ISSN： 0092-8674            Impact factor:   41.582


  12 in total

Review 1.  Precision oncology in metastatic colorectal cancer - from biology to medicine.

Authors:  Federica Di Nicolantonio; Pietro Paolo Vitiello; Silvia Marsoni; Salvatore Siena; Josep Tabernero; Livio Trusolino; Rene Bernards; Alberto Bardelli
Journal:  Nat Rev Clin Oncol       Date:  2021-04-16       Impact factor: 66.675

2.  Neoadjuvant Systemic Therapy (NAST) in Patients with Melanoma: Surgical Considerations by the International Neoadjuvant Melanoma Consortium (INMC).

Authors:  Alexander C J van Akkooi; Tina J Hieken; Elizabeth M Burton; Andrew J Spillane; Merrick I Ross; Charlotte Ariyan; Paolo A Ascierto; Salvatore V M A Asero; Christian U Blank; Matthew S Block; Genevieve M Boland; Corrado Caraco; Sydney Chng; B Scott Davidson; Joao Pedreira Duprat Neto; Mark B Faries; Jeffrey E Gershenwald; Dirk J Grunhagen; David E Gyorki; Dale Han; Andrew J Hayes; Winan J van Houdt; Giorgos C Karakousis; Willem M C Klop; Georgina V Long; Michael C Lowe; Alexander M Menzies; Roger Olofsson Bagge; Thomas E Pennington; Piotr Rutkowski; Robyn P M Saw; Richard A Scolyer; Kerwin F Shannon; Vernon K Sondak; Hussein Tawbi; Alessandro A E Testori; Mike T Tetzlaff; John F Thompson; Jonathan S Zager; Charlotte L Zuur; Jennifer A Wargo
Journal:  Ann Surg Oncol       Date:  2022-01-28       Impact factor: 5.344

Review 3.  Facing the urgency of therapies for progressive MS - a Progressive MS Alliance proposal.

Authors:  Fernando Dangond; Alexis Donnelly; Reinhard Hohlfeld; Catherine Lubetzki; Susan Kohlhaas; Letizia Leocani; Olga Ciccarelli; Bruno Stankoff; Maria Pia Sormani; Jeremy Chataway; Federico Bozzoli; Francesco Cucca; Lisa Melton; Timothy Coetzee; Marco Salvetti
Journal:  Nat Rev Neurol       Date:  2021-01-22       Impact factor: 42.937

4.  TRK Fusion Cancer: Patient Characteristics and Survival Analysis in the Real-World Setting.

Authors:  Lyudmila Bazhenova; Andrew Lokker; Jeremy Snider; Emily Castellanos; Virginia Fisher; Marc Fellous; Shivani Nanda; Jihong Zong; Karen Keating; Xiaolong Jiao
Journal:  Target Oncol       Date:  2021-04-24       Impact factor: 4.493

5.  Standards for the classification of pathogenicity of somatic variants in cancer (oncogenicity): Joint recommendations of Clinical Genome Resource (ClinGen), Cancer Genomics Consortium (CGC), and Variant Interpretation for Cancer Consortium (VICC).

Authors:  Peter Horak; Malachi Griffith; Arpad M Danos; Beth A Pitel; Subha Madhavan; Xuelu Liu; Cynthia Chow; Heather Williams; Leigh Carmody; Lisa Barrow-Laing; Damian Rieke; Simon Kreutzfeldt; Albrecht Stenzinger; David Tamborero; Manuela Benary; Padma Sheila Rajagopal; Cristiane M Ida; Harry Lesmana; Laveniya Satgunaseelan; Jason D Merker; Michael Y Tolstorukov; Paulo Vidal Campregher; Jeremy L Warner; Shruti Rao; Maya Natesan; Haolin Shen; Jeffrey Venstrom; Somak Roy; Kayoko Tao; Rashmi Kanagal-Shamanna; Xinjie Xu; Deborah I Ritter; Kym Pagel; Kilannin Krysiak; Adrian Dubuc; Yassmine M Akkari; Xuan Shirley Li; Jennifer Lee; Ian King; Gordana Raca; Alex H Wagner; Marylin M Li; Sharon E Plon; Shashikant Kulkarni; Obi L Griffith; Debyani Chakravarty; Dmitriy Sonkin
Journal:  Genet Med       Date:  2022-01-29       Impact factor: 8.864

6.  Factors Affecting Citizen Trust and Public Engagement Relating to the Generation and Use of Real-World Evidence in Healthcare.

Authors:  Denis Horgan; Bettina Borisch; Ivana Cattaneo; Mark Caulfield; Arturo Chiti; Christine Chomienne; Amanda Cole; Karen Facey; Allan Hackshaw; Minna Hendolin; Nadia Georges; Dipak Kalra; Birutė Tumienė; Martina von Meyenn
Journal:  Int J Environ Res Public Health       Date:  2022-02-01       Impact factor: 3.390

7.  mTORC1 promotes malignant large cell/anaplastic histology and is a targetable vulnerability in SHH-TP53 mutant medulloblastoma.

Authors:  Valentina Conti; Manuela Cominelli; Valentina Pieri; Alberto L Gallotti; Ilaria Pagano; Matteo Zanella; Stefania Mazzoleni; Flavia Pivetta; Monica Patanè; Giulia M Scotti; Ignazio S Piras; Bianca Pollo; Andrea Falini; Alessio Zippo; Antonella Castellano; Roberta Maestro; Pietro L Poliani; Rossella Galli
Journal:  JCI Insight       Date:  2021-12-08

Review 8.  Translational precision medicine: an industry perspective.

Authors:  Dominik Hartl; Valeria de Luca; Anna Kostikova; Jason Laramie; Scott Kennedy; Enrico Ferrero; Richard Siegel; Martin Fink; Sohail Ahmed; John Millholland; Alexander Schuhmacher; Markus Hinder; Luca Piali; Adrian Roth
Journal:  J Transl Med       Date:  2021-06-05       Impact factor: 5.531

Review 9.  Clinical trial design: Past, present, and future in the context of big data and precision medicine.

Authors:  Allen Li; Raymond C Bergan
Journal:  Cancer       Date:  2020-09-15       Impact factor: 6.860

10.  Identifying the Steps Required to Effectively Implement Next-Generation Sequencing in Oncology at a National Level in Europe.

Authors:  Denis Horgan; Giuseppe Curigliano; Olaf Rieß; Paul Hofman; Reinhard Büttner; Pierfranco Conte; Tanja Cufer; William M Gallagher; Nadia Georges; Keith Kerr; Frédérique Penault-Llorca; Ken Mastris; Carla Pinto; Jan Van Meerbeeck; Elisabetta Munzone; Marlene Thomas; Sonia Ujupan; Gilad W Vainer; Janna-Lisa Velthaus; Fabrice André
Journal:  J Pers Med       Date:  2022-01-08
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