Rajeshwari Sridhara - AILBRY

Results for 'Rajeshwari Sridhara' :

Q&A: Rajeshwari Sridhara, Robert Temple on Trial Design

Publication Year: 2013

DOI: https://doi.org/10.1158/2159-8290.cd-nd2013-005

Abstract:

Authors:
- Rajeshwari Sridhara
- Robert Temple
Clinical trials handbook

Publication Year: 2009

DOI: DOI not available

Abstract:

Authors:
- Shayne C. Gad
Balancing Benefit, Risk, and Time to New Cancer Therapies

Publication Year: 2015

DOI: https://doi.org/10.1001/jamaoncol.2015.4126

Abstract:

Authors:
- Howard West
Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015

Publication Year: 2017

DOI: https://doi.org/10.1200/jco.2017.73.4186

Abstract:

Authors:
- Susan Jin
- Richard Pazdur
- Rajeshwari Sridhara
Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop

Publication Year: 2017

DOI: https://doi.org/10.1016/j.jval.2017.09.009

Abstract:

Authors:
- Paul G. Kluetz
- Bindu Kanapuru
- Steven J. Lemery
- Laura Lee Johnson
- Mallorie H. Fiero
- Karen Arscott
- Yolanda Barbáchano
- Ethan Basch
- Michelle Campbell
- Joseph C. Cappelleri
- David Cella
- Charles S. Cleeland
- Corneel Coens
- Selena Daniels
- Crystal S. Denlinger
- Dianne L. Fairclough
- James R. Hillard
- Lori M. Minasian
- Sandra A. Mitchell
- Daniel O’Connor
- Sheetal Patel
- Eric H. Rubin
- Anna Rydén
- Katherine M Soltys
- Rajeshwari Sridhara
- Gita Thanarajasingam
- Galina Velikova
- Stephen Joel Coons
Adaptive Clinical Trial Designs for Simultaneous Testing of Matched Diagnostics and Therapeutics

Publication Year: 2011

DOI: https://doi.org/10.1158/1078-0432.ccr-11-1105

Abstract:

Authors:
- Howard I. Scher
- S Nasso
- Eric H. Rubin
- Richard H. Simon
Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy

Publication Year: 2016

DOI: https://doi.org/10.1158/1078-0432.ccr-15-2644

Abstract:

Authors:
- Lei Nie
- Eric H. Rubin
- Nitin Mehrotra
- José Cirı́aco Pinheiro
- Laura L. Fernandes
- Amit Roy
- Stuart Bailey
- Dinesh P. de Alwis
Accelerated Approval and Oncology Drug Development Timelines

Publication Year: 2010

DOI: https://doi.org/10.1200/jco.2009.26.2121

Abstract:

Authors:
- Michael Lanthier
- Rajeshwari Sridhara
- John R. Johnson
- Ann T. Farrell
- Patricia Keegan
- Robert Justice
- Richard Pazdur
Use of Nonconcurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion

Publication Year: 2021

DOI: https://doi.org/10.1080/19466315.2021.1938204

Abstract:

Authors:
- Rajeshwari Sridhara
- Olga Marchenko
- Qi Jiang
- Richard Pazdur
- Martin Posch
- Scott Berry
- Marc R. Theoret
- Yuan Li Shen
- Thomas Gwise
- Lorenzo Hess
- Andrew Raven
- Khadija Rantell
- Kit C. B. Roes
- Richard H. Simon
- Mary W. Redman
- Yuan Ji
- Cindy Lu
Report of the Jumpstarting Brain Tumor Drug Development Coalition and FDA clinical trials clinical outcome assessment endpoints workshop (October 15, 2014, Bethesda MD)

Publication Year: 2016

DOI: https://doi.org/10.1093/neuonc/nov270

Abstract:

Authors:
- Jennifer L. Helfer
- Patrick Y. Wen
- Jaishri O. Blakeley
- Mark R. Gilbert
- Terri S. Armstrong
Report of the Jumpstarting Brain Tumor Drug Development Coalition and FDA clinical trials neuroimaging endpoint workshop (January 30, 2014, Bethesda MD)

Publication Year: 2014

DOI: https://doi.org/10.1093/neuonc/nou226

Abstract:

Authors:
- Patrick Y. Wen
- Timothy F. Cloughesy
- Benjamin M. Ellingson
- David A. Reardon
- Howard A. Fine
- Lauren E. Abrey
- Karla V. Ballman
- Martin Bendszuz
- Jan C. Buckner
- Susan M. Chang
- Michael D. Prados
- Whitney B. Pope
- A. Gregory Sorensen
- Martin J. van den Bent
- Wai-Kwan Alfred Yung
Bayesian hierarchical methods for meta-analysis combining randomized-controlled and single-arm studies

Publication Year: 2018

DOI: https://doi.org/10.1177/0962280218754928

Abstract:

Authors:
- Jing Zhang
- Chia‐Wen Ko
- Lei Nie
- Yong Chen
- Ram C. Tiwari
Consensus Report of a Joint NCI Thoracic Malignancies Steering Committee: FDA Workshop on Strategies for Integrating Biomarkers into Clinical Development of New Therapies for Lung Cancer Leading to the Inception of “Master Protocols” in Lung Cancer

Publication Year: 2014

DOI: https://doi.org/10.1097/jto.0000000000000314

Abstract:

Authors:
- Shakun Malik
- Richard Pazdur
- Jeffrey S. Abrams
- Mark A. Socinski
- William T. Sause
- David H. Harpole
- John J. Welch
- Edward L. Korn
- Claudio Dansky Ullmann
- Fred R. Hirsch
Statistics at FDA: Reflections on the Past Six Years

Publication Year: 2019

DOI: https://doi.org/10.1080/19466315.2019.1571322

Abstract:

Authors:
- Lisa M. LaVange
Re: Prediction of Carboplatin Clearance From Standard Morphological and Biological Patient Characteristics

Publication Year: 1997

DOI: https://doi.org/10.1093/jnci/89.20.1546-a

Abstract:

Authors:
- R. Sridhara

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Results for 'Rajeshwari Sridhara' :

Q&amp;A: Rajeshwari Sridhara, Robert Temple on Trial Design

Clinical trials handbook

Balancing Benefit, Risk, and Time to New Cancer Therapies

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

Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop

Adaptive Clinical Trial Designs for Simultaneous Testing of Matched Diagnostics and Therapeutics

Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy

Accelerated Approval and Oncology Drug Development Timelines

Use of Nonconcurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion

Report of the Jumpstarting Brain Tumor Drug Development Coalition and FDA clinical trials clinical outcome assessment endpoints workshop (October 15, 2014, Bethesda MD)

Report of the Jumpstarting Brain Tumor Drug Development Coalition and FDA clinical trials neuroimaging endpoint workshop (January 30, 2014, Bethesda MD)

Bayesian hierarchical methods for meta-analysis combining randomized-controlled and single-arm studies

Consensus Report of a Joint NCI Thoracic Malignancies Steering Committee: FDA Workshop on Strategies for Integrating Biomarkers into Clinical Development of New Therapies for Lung Cancer Leading to the Inception of “Master Protocols” in Lung Cancer

Statistics at FDA: Reflections on the Past Six Years

Re: Prediction of Carboplatin Clearance From Standard Morphological and Biological Patient Characteristics

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Q&A: Rajeshwari Sridhara, Robert Temple on Trial Design