Literature DB >> 32112057

Real-world evidence and regulatory drug approval.

Michael J Raphael1,2,3, Bishal Gyawali1,2,3,4, Christopher M Booth5,6,7.   

Abstract

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Year:  2020        PMID： 32112057     DOI： 10.1038/s41571-020-0345-7

Source DB:  PubMed          Journal:  Nat Rev Clin Oncol        ISSN： 1759-4774            Impact factor:   66.675


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  1 in total

1.  FDA Approval Summary: Palbociclib for Male Patients with Metastatic Breast Cancer.

Authors:  Suparna Wedam; Lola Fashoyin-Aje; Erik Bloomquist; Shenghui Tang; Rajeshwari Sridhara; Kirsten B Goldberg; Marc R Theoret; Laleh Amiri-Kordestani; Richard Pazdur; Julia A Beaver
Journal:  Clin Cancer Res       Date:  2019-10-24       Impact factor: 12.531
  1 in total
  9 in total

Review 1.  Advancing Pharmacogenomics from Single-Gene to Preemptive Testing.

Authors:  Cyrine E Haidar; Kristine R Crews; James M Hoffman; Mary V Relling; Kelly E Caudle
Journal:  Annu Rev Genomics Hum Genet       Date:  2022-05-10       Impact factor: 9.340

2.  Cancer treatments should benefit patients: a common-sense revolution in oncology.

Authors:  Bishal Gyawali; Christopher M Booth
Journal:  Nat Med       Date:  2022-04       Impact factor: 87.241

Review 3.  A multi-stakeholder approach in optimising patients' needs in the benefit assessment process of new metastatic breast cancer treatments.

Authors:  Fatima Cardoso; Nils Wilking; Renato Bernardini; Laura Biganzoli; Jaime Espin; Kaisa Miikkulainen; Susanne Schuurman; Danielle Spence; Sabine Spitz; Sonia Ujupan; Nicole Zernik; Jenn Gordon
Journal:  Breast       Date:  2020-05-10       Impact factor: 4.380

4.  EA3: A softmax algorithm for evidence appraisal aggregation.

Authors:  Francesco De Pretis; Jürgen Landes
Journal:  PLoS One       Date:  2021-06-17       Impact factor: 3.240

5.  Emulating Control Arms for Cancer Clinical Trials Using External Cohorts Created From Electronic Health Record-Derived Real-World Data.

Authors:  Katherine Tan; Jonathan Bryan; Brian Segal; Lawrence Bellomo; Nate Nussbaum; Melisa Tucker; Aracelis Z Torres; Carrie Bennette; William Capra; Melissa Curtis; Rebecca A Miksad
Journal:  Clin Pharmacol Ther       Date:  2021-07-31       Impact factor: 6.903

6.  Developing a Canadian Real-World Evidence Action Plan across the Drug Life Cycle.

Authors:  Mina Tadrous; Tarry Ahuja; Basanti Ghosh; Rhonda Kropp
Journal:  Healthc Policy       Date:  2020-05

7.  Real-World Experience on Omalizumab Treatment for Patients with Normocomplementemic Urticarial Vasculitis.

Authors:  Taoming Liu; Juan Bai; Shuni Ying; Sheng Li; Yunlei Pan; Deren Fang; Jianjun Qiao; Hong Fang
Journal:  J Asthma Allergy       Date:  2021-04-23

8.  Validation analysis of a composite real-world mortality endpoint for patients with cancer in the United States.

Authors:  Qianyi Zhang; Anala Gossai; Shirley Monroe; Nathan C Nussbaum; Christina M Parrinello
Journal:  Health Serv Res       Date:  2021-05-17       Impact factor: 3.402

9.  Real-world outcomes associated with new cancer medicines approved by the Food and Drug Administration and European Medicines Agency: A retrospective cohort study.

Authors:  Jemma M Boyle; Gemma Hegarty; Christopher Frampton; Elizabeth Harvey-Jones; Joanna Dodkins; Katharina Beyer; Gincy George; Richard Sullivan; Christopher Booth; Ajay Aggarwal
Journal:  Eur J Cancer       Date:  2021-08-06       Impact factor: 9.162
  9 in total

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