Patricia Keegan

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All published works
Action Title Year Authors
+ PDF Chat Flat dose regimen of toripalimab based on model-informed drug development approach 2023 Lili Li
Jianye Qu
Ming Song
Qun Zhao
Yonghua Yang
Xi Tan
Yanyan Hu
Jing Li
Yunfei Lin
Hui Feng
+ PDF Chat Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs 2019 Janice Kim
Abhilasha Nair
Patricia Keegan
Julia A. Beaver
Paul G. Kluetz
Richard Pazdur
Meredith K. Chuk
Gideon M. Blumenthal
+ Evolving Early Phase Trial Designs 2018 Marc R. Theoret
Lee H. Pai-Scherf
Christy L. Osgood
Abhilasha Nair
Patricia Keegan
+ Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study 2016 Kun He
Huanyu Chen
Thomas Gwise
Sandra J. Casak
Steven J. Lemery
Patricia Keegan
Richard Pazdur
Rajeshwari Sridhara
+ PDF Chat Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials 2015 Marc R. Theoret
Lee H. Pai-Scherf
Meredith K. Chuk
Tatiana M. Prowell
Sanjeeve Balasubramaniam
Tamy Kim
Geoffrey Kim
Paul G. Kluetz
Patricia Keegan
Richard Pazdur
+ Special protocol assessments: 10 years of experience in FDA’s Office of Hematology and Oncology Products. 2014 Virginia Ellen Maher
Alice Kacuba
Yang‐Min Ning
Anthony J. Murgo
Amna Ibrahim
Ann T. Farrell
Patricia Keegan
Robert Justice
Richard Pazdur
+ Evaluation of Blinded Independent Central Review of Tumor Progression in Oncology Clinical Trials: A Meta-analysis 2012 Jenny J. Zhang
Huanyu Chen
Kun He
Shenghui Tang
Robert Justice
Patricia Keegan
Richard Pazdur
Rajeshwari Sridhara
+ The Combination of Exposure‐Response and Case‐Control Analyses in Regulatory Decision Making 2012 Jun Yang
Hong Zhao
Christine Garnett
Atiqur Rahman
Jogarao Gobburu
William F. Pierce
Genevieve Schechter
Jeffery J. Summers
Patricia Keegan
Brian Booth
+ Review of Oncology and Hematology Drug Product Approvals at the US Food and Drug Administration Between July 2005 and December 2007 2010 R. Sridhara
John R. Johnson
Robert Justice
Patricia Keegan
Aloka Chakravarty
Richard Pazdur
+ PDF Chat Accelerated Approval of Oncology Products: A Decade of Experience 2004 Ramzi Dagher
John R. Johnson
Grant Williams
Patricia Keegan
Richard Pazdur
Common Coauthors
Commonly Cited References
Action Title Year Authors # of times referenced
+ End Points and United States Food and Drug Administration Approval of Oncology Drugs 2003 John R. Johnson
Grant Williams
Richard Pazdur
2
+ PDF Chat Evolution of Clinical Trial Design in Early Drug Development: Systematic Review of Expansion Cohort Use in Single-Agent Phase I Cancer Trials 2013 Arif Manji
Irene Braña
Eitan Amir
George Tomlinson
Ian F. Tannock
Philippe L. BĂ©dard
Amit M. Oza
Lillian L. Siu
Albiruni R. Abdul Razak
2
+ Current definitions of phases of investigation and the role of the FDA in the conduct of clinical trials 2000 Robert Temple
2
+ PDF Chat Evaluation of Statistical Designs in Phase I Expansion Cohorts: The Dana-Farber/Harvard Cancer Center Experience 2014 Suzanne E. Dahlberg
Geoffrey I. Shapiro
Jeffrey W. Clark
Bruce E. Johnson
2
+ Impact of pharmacometrics on drug approval and labeling decisions: A survey of 42 new drug applications 2005 Venkatesh Atul Bhattaram
Brian Booth
Roshni Ramchandani
B. Nhi Beasley
Yaning Wang
Veneeta Tandon
John Duan
Raman Baweja
Patrick Marroum
Ramana Uppoor
1
+ Non‐inferiority trials: design concepts and issues – the encounters of academic consultants in statistics 2002 Ralph B. D’Agostino
Joseph M. Massaro
Lisa Sullivan
1
+ Optimizing Dosing of Oncology Drugs 2014 Lori M. Minasian
Osnat Rosen
Daniel Auclair
Atiqur Rahman
Richard Pazdur
Richard L. Schilsky
1
+ PDF Chat Optimal two-stage designs for phase II clinical trials 1989 Richard Simon
1
+ PDF Chat A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability 1987 Donald J. Schuirmann
1
+ PDF Chat An Audit Strategy for Progression-Free Survival 2011 Lori E. Dodd
Edward L. Korn
Boris Freidlin
Robert J. Gray
Suman Bhattacharya
1
+ PDF Chat Blinded Independent Central Review of Progression-Free Survival in Phase III Clinical Trials: Important Design Element or Unnecessary Expense? 2008 Lori E. Dodd
Edward L. Korn
Boris Freidlin
C. Carl Jaffe
Larry Rubinstein
Janet Dancey
Margaret Mooney
1
+ Evaluation of Health-Related Quality-of-Life Measures in Oncology Drug Product Applications: Issues and Concerns 2004 Rajeshwari Sridhara
Gang Chen
Y. H. George
Donna Griebel
1
+ PDF Chat Blinded Independent Central Review of the Progression-Free Survival Endpoint 2010 Ohad Amit
Will Bushnell
Lori E. Dodd
Nancy Roach
Daniel J. Sargent
1
+ Measurement error in the timing of events: effect on survival analyses in randomized clinical trials 2010 Edward L. Korn
Lori E. Dodd
Boris Freidlin
1
+ Modeling and Simulation of the Time Course of Asenapine Exposure Response and Dropout Patterns in Acute Schizophrenia 2009 Lena E. Friberg
Rik de Greef
Thomas Kerbusch
MO Karlsson
1
+ Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group 2011 A Stone
William D. Bushnell
Jon Denne
Daniel J. Sargent
Ohad Amit
C. CHEN
R. Bailey-Iacona
Jeffrey D. Helterbrand
Grant Williams
1
+ PDF Chat Design Considerations for Dose-Expansion Cohorts in Phase I Trials 2013 Alexia Iasonos
John O’Quigley
1
+ PDF Chat Bioequivalence trials, intersection-union tests and equivalence confidence sets 1996 Roger L. Berger
Jason C. Hsu
1
+ Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group 1998 Ralph B. D’Agostino
1
+ Recommendations for the assessment of progression in randomised cancer treatment trials 2008 Janet Dancey
Lori E. Dodd
Robert Ford
Richard Kaplan
Margaret Mooney
Larry Rubinstein
Lawrence H. Schwartz
Lalitha Shankar
P. Therasse
1
+ PDF Chat Accelerated Approval of Oncology Products: A Decade of Experience 2004 Ramzi Dagher
John R. Johnson
Grant Williams
Patricia Keegan
Richard Pazdur
1
+ PDF Chat Through the looking glass: understanding non-inferiority 2011 Jennifer Schumi
Janet Wittes
1
+ Current issues in non‐inferiority trials 2007 Thomas R. Fleming
1
+ PDF Chat Challenges to Use of Health-Related Quality of Life for Food and Drug Administration Approval of Anticancer Products 2007 Edwin P. Rock
Jane Scott
Dianne L. Kennedy
R. Sridhara
Richard Pazdur
Laurie B. Burke
1
+ PDF Chat Influence of an independent review committee on assessment of response rate and progression-free survival in phase III clinical trials 2009 Patricia A. Tang
Gregory R. Pond
Eric X. Chen
1
+ Blinded independent central review of progression in cancer clinical trials: Results from a meta-analysis 2011 Ohad Amit
Frank Mannino
A Stone
William D. Bushnell
Jonathan Denne
Jeffrey D. Helterbrand
Hans-Ulrich Burger
1
+ Statistical and Regulatory Issues with the Application of Propensity Score Analysis to Nonrandomized Medical Device Clinical Studies 2006 Lilly Q. Yue
1
+ PDF Chat Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials 2015 Marc R. Theoret
Lee H. Pai-Scherf
Meredith K. Chuk
Tatiana M. Prowell
Sanjeeve Balasubramaniam
Tamy Kim
Geoffrey Kim
Paul G. Kluetz
Patricia Keegan
Richard Pazdur
1
+ PDF Chat Statistical Primer on Biosimilar Clinical Development 2016 Leah Isakov
Bo Jin
Ira Jacobs
1
+ PDF Chat Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies 2017 Gideon M. Blumenthal
Paul G. Kluetz
Julie A. Schneider
Kirsten B. Goldberg
Amy E. McKee
Richard Pazdur
1
+ PDF Chat Real-world Data for Clinical Evidence Generation in Oncology 2017 Sean Khozin
Gideon M. Blumenthal
Richard Pazdur
1
+ Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations 2019 Yaning Wang
Hao Zhu
Rajanikanth Madabushi
Qi Liu
Shiew‐Mei Huang
Issam Zineh
1
+ Oncology's trials 2003 Bruce L Booth
Robert H. Glassman
Philip Ma
1
+ Design and Analysis of Non-Inferiority Trials 2011 Mark Rothmann
Brian L. Wiens
Ivan S. F. Chan
1
+ Is it time to abandon complete blinded independent central radiological evaluation of progression in registration trials? 2011 Francesco Pignatti
Rob Hemmings
Bertil Jönsson
1
+ Evaluation of false positive rate based on exposure–response analyses for two compounds in fixed-dose combination products 2011 Hao Zhu
Yaning Wang
1
+ How is retrospective independent review influenced by investigator‐introduced informative censoring: A quantitative approach 2011 Frank Fleischer
Birgit Gaschler‐Markefski
Erich Bluhmki
1