Literature DB >> 33910935

The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology.

Julie A Schneider1, Yutao Gong1, Kirsten B Goldberg1, Paul G Kluetz1,2, Marc R Theoret1,2, Laleh Amiri-Kordestani2, Julia A Beaver1,2, Lola Fashoyin-Aje1,2, Nicole J Gormley2, Adnan A Jaigirdar1,3, Steven J Lemery1,2, Pallavi S Mishra-Kalyani4, Gregory H Reaman1, Donna R Rivera1, Wendy S Rubinstein1,5, Harpreet Singh1,2, Rajeshwari Sridhara1, Richard Pazdur1,2.   

Abstract

The FDA Oncology Center of Excellence (OCE) is a leader within the agency in scientific outreach activities and regulatory science research. On the basis of analysis of scientific workshops, internal meetings, and publications, the OCE identified nine scientific priority areas and one cross-cutting area of high interest for collaboration with external researchers. This article describes the process for identifying these scientific interest areas and highlights funded and unfunded opportunities for external researchers to work with FDA staff on critical regulatory science challenges. ©2021 American Association for Cancer Research.

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Year:  2021        PMID: 33910935      PMCID: PMC8551300          DOI: 10.1158/1078-0432.CCR-20-4429

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN: 1078-0432            Impact factor:   12.531


  25 in total

1.  Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody.

Authors:  V Ellen Maher; Laura L Fernandes; Chana Weinstock; Shenghui Tang; Sundeep Agarwal; Michael Brave; Yang-Min Ning; Harpreet Singh; Daniel Suzman; James Xu; Kirsten B Goldberg; Rajeshwari Sridhara; Amna Ibrahim; Marc Theoret; Julia A Beaver; Richard Pazdur
Journal:  J Clin Oncol       Date:  2019-05-22       Impact factor: 44.544

2.  Exploration of a Novel Intermediate Response Endpoint in Immunotherapy Clinical Studies.

Authors:  Xin Gao; Lijun Zhang; Rajeshwari Sridhara
Journal:  Clin Cancer Res       Date:  2017-12-26       Impact factor: 12.531

3.  Minimal Residual Disease as a Potential Surrogate End Point-Lingering Questions.

Authors:  Nicole J Gormley; Ann T Farrell; Richard Pazdur
Journal:  JAMA Oncol       Date:  2017-01-01       Impact factor: 31.777

4.  Pediatric Development of Molecularly Targeted Oncology Drugs.

Authors:  Shivam Kamlesh Patel; Ruby Leong; Hong Zhao; Amy Barone; Denise Casey; Qi Liu; Gilbert J Burckart; Gregory Reaman
Journal:  Clin Pharmacol Ther       Date:  2017-12-11       Impact factor: 6.875

5.  An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products.

Authors:  Michael L Manning; Matthew D Thompson; Haleh Saber; Virginia E Maher; Joyce Z Crich; John K Leighton
Journal:  Regul Toxicol Pharmacol       Date:  2019-10-31       Impact factor: 3.271

6.  Analyzing patient-reported outcome data when completion differs between arms in open-label trials: an application of principal stratification.

Authors:  Jessica K Roydhouse; Roee Gutman; Vishal Bhatnagar; Paul G Kluetz; Rajeshwari Sridhara; Pallavi S Mishra-Kalyani
Journal:  Pharmacoepidemiol Drug Saf       Date:  2019-08-13       Impact factor: 2.890

Review 7.  Characterization of outcomes in patients with metastatic non-small cell lung cancer treated with programmed cell death protein 1 inhibitors past RECIST version 1.1-defined disease progression in clinical trials.

Authors:  Dickran Kazandjian; Patricia Keegan; Daniel L Suzman; Richard Pazdur; Gideon M Blumenthal
Journal:  Semin Oncol       Date:  2017-02-10       Impact factor: 4.929

8.  A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials.

Authors:  L Amiri-Kordestani; D Xie; S M Tolaney; E Bloomquist; S Tang; A Ibrahim; K B Goldberg; M R Theoret; R Pazdur; R Sridhara; E P Winer; J A Beaver
Journal:  Ann Oncol       Date:  2020-08-28       Impact factor: 32.976

9.  Time dependent pharmacokinetics of pembrolizumab in patients with solid tumor and its correlation with best overall response.

Authors:  Hongshan Li; Jingyu Yu; Chao Liu; Jiang Liu; Sriram Subramaniam; Hong Zhao; Gideon M Blumenthal; David C Turner; Claire Li; Malidi Ahamadi; Rik de Greef; Manash Chatterjee; Anna G Kondic; Julie A Stone; Brian P Booth; Patricia Keegan; Atiqur Rahman; Yaning Wang
Journal:  J Pharmacokinet Pharmacodyn       Date:  2017-06-01       Impact factor: 2.745

10.  Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015.

Authors:  Susan Jin; Richard Pazdur; Rajeshwari Sridhara
Journal:  J Clin Oncol       Date:  2017-10-02       Impact factor: 44.544

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