Literature DB >> 34718780

External controls to improve on glioblastoma clinical trials.

Annette M Molinaro1,2.   

Abstract

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Mesh：

Year:  2022        PMID： 34718780      PMCID： PMC8804878          DOI： 10.1093/neuonc/noab251

Source DB:  PubMed          Journal:  Neuro Oncol        ISSN： 1522-8517            Impact factor:   13.029


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  7 in total

1.  Design and Evaluation of an External Control Arm Using Prior Clinical Trials and Real-World Data.

Authors:  Steffen Ventz; Albert Lai; Timothy F Cloughesy; Patrick Y Wen; Lorenzo Trippa; Brian M Alexander
Journal:  Clin Cancer Res       Date:  2019-06-07       Impact factor: 12.531

2.  Point/counterpoint: randomized versus single-arm phase II clinical trials for patients with newly diagnosed glioblastoma.

Authors:  Stuart A Grossman; Karisa C Schreck; Karla Ballman; Brian Alexander
Journal:  Neuro Oncol       Date:  2017-04-01       Impact factor: 12.300

3.  Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness.

Authors:  Jacqueline Corrigan-Curay; Leonard Sacks; Janet Woodcock
Journal:  JAMA       Date:  2018-09-04       Impact factor: 56.272

4.  Informing single-arm clinical trials with external controls.

Authors:  Ruthie Davi; Nirosha Mahendraratnam; Arnaub Chatterjee; C Jill Dawson; Rachel Sherman
Journal:  Nat Rev Drug Discov       Date:  2020-12       Impact factor: 112.288

Review 5.  A Review of Perspectives on the Use of Randomization in Phase II Oncology Trials.

Authors:  Michael J Grayling; Munyaradzi Dimairo; Adrian P Mander; Thomas F Jaki
Journal:  J Natl Cancer Inst       Date:  2019-12-01       Impact factor: 13.506

6.  Real-world evidence to support regulatory decision-making for medicines: Considerations for external control arms.

Authors:  Mehmet Burcu; Nancy A Dreyer; Jessica M Franklin; Michael D Blum; Cathy W Critchlow; Eleanor M Perfetto; Wei Zhou
Journal:  Pharmacoepidemiol Drug Saf       Date:  2020-03-11       Impact factor: 2.890

7.  The use of external control data for predictions and futility interim analyses in clinical trials.

Authors:  Steffen Ventz; Leah Comment; Bill Louv; Rifaquat Rahman; Patrick Y Wen; Brian M Alexander; Lorenzo Trippa
Journal:  Neuro Oncol       Date:  2022-02-01       Impact factor: 13.029
  7 in total

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