Literature DB >> 28232724

Regulatory watch: From big data to smart data: FDA's INFORMED initiative.

Sean Khozin1, Geoffrey Kim1, Richard Pazdur1.   

Abstract

Mesh：

Year:  2017        PMID： 28232724     DOI： 10.1038/nrd.2017.26

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


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  10 in total

1.  Commentary on Perez et al.: How to create a 21st century adverse event reporting system.

Authors:  Elad Sharon
Journal:  Clin Trials       Date:  2017-03-26       Impact factor: 2.486

2.  INFORMED: an incubator at the US FDA for driving innovations in data science and agile technology.

Authors:  Sean Khozin; Richard Pazdur; Anand Shah
Journal:  Nat Rev Drug Discov       Date:  2018-04-06       Impact factor: 84.694

3.  The Influence of Big (Clinical) Data and Genomics on Precision Medicine and Drug Development.

Authors:  Joshua C Denny; Sara L Van Driest; Wei-Qi Wei; Dan M Roden
Journal:  Clin Pharmacol Ther       Date:  2018-02-05       Impact factor: 6.875

Review 4.  Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.

Authors:  Gita Thanarajasingam; Lori M Minasian; Frederic Baron; Franco Cavalli; R Angelo De Claro; Amylou C Dueck; Tarec C El-Galaly; Neil Everest; Jan Geissler; Christian Gisselbrecht; John Gribben; Mary Horowitz; S Percy Ivy; Caron A Jacobson; Armand Keating; Paul G Kluetz; Aviva Krauss; Yok Lam Kwong; Richard F Little; Francois-Xavier Mahon; Matthew J Matasar; María-Victoria Mateos; Kristen McCullough; Robert S Miller; Mohamad Mohty; Philippe Moreau; Lindsay M Morton; Sumimasa Nagai; Simon Rule; Jeff Sloan; Pieter Sonneveld; Carrie A Thompson; Kyriaki Tzogani; Flora E van Leeuwen; Galina Velikova; Diego Villa; John R Wingard; Sophie Wintrich; John F Seymour; Thomas M Habermann
Journal:  Lancet Haematol       Date:  2018-06-18       Impact factor: 18.959

Review 5.  The FDA Oncology Center of Excellence and precision medicine.

Authors:  Kirsten B Goldberg; Gideon M Blumenthal; Amy E McKee; Richard Pazdur
Journal:  Exp Biol Med (Maywood)       Date:  2017-11-06

6.  Toward a Tiered Model to Share Clinical Trial Data and Samples in Precision Oncology.

Authors:  Stefanie Broes; Denis Lacombe; Michiel Verlinden; Isabelle Huys
Journal:  Front Med (Lausanne)       Date:  2018-01-29

7.  ePCR: an R-package for survival and time-to-event prediction in advanced prostate cancer, applied to real-world patient cohorts.

Authors:  Teemu D Laajala; Mika Murtojärvi; Arho Virkki; Tero Aittokallio
Journal:  Bioinformatics       Date:  2018-11-15       Impact factor: 6.937

8.  Is surgical axillary staging necessary in women with T1 breast cancer who are treated with breast-conserving therapy?

Authors:  Jin Wang; Hailin Tang; Xing Li; Cailu Song; Zhenchong Xiong; Xi Wang; Xiaoming Xie; Jun Tang
Journal:  Cancer Commun (Lond)       Date:  2019-05-08

9.  Using Electronic Health Records to Derive Control Arms for Early Phase Single-Arm Lung Cancer Trials: Proof-of-Concept in Randomized Controlled Trials.

Authors:  Gillis Carrigan; Samuel Whipple; William B Capra; Michael D Taylor; Jeffrey S Brown; Michael Lu; Brandon Arnieri; Ryan Copping; Kenneth J Rothman
Journal:  Clin Pharmacol Ther       Date:  2019-10-11       Impact factor: 6.875

10.  Harnessing the Power of Real-World Evidence (RWE): A Checklist to Ensure Regulatory-Grade Data Quality.

Authors:  Rebecca A Miksad; Amy P Abernethy
Journal:  Clin Pharmacol Ther       Date:  2017-12-06       Impact factor: 6.875
  10 in total

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