Publications by authors named "Kenneth A Getz"

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Assessing the Value of Integrated Evidence Approaches in Drug Development.
Joseph A DiMasi, Melvin Skip Olson, Zachary Smith, Kenneth A Getz, Gorana Capkun

Ther Innov Regul Sci· July 2025

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New Estimates on the Cost of a Delay Day in Drug Development.
Zachary P Smith, Joseph A DiMasi, Kenneth A Getz

Ther Innov Regul Sci· September 2024

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Assessing the net financial benefits of employing digital endpoints in clinical trials.
Joseph A DiMasi, Abigail Dirks, Zachary Smith, Sarah Valentine, Jennifer C Goldsack, Kenneth A Getz

Clin Transl Sci· August 2024

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Assessing the Financial Value of Decentralized Clinical Trials.
Joseph A DiMasi, Zachary Smith, Ingrid Oakley-Girvan, Andrew Mackinnon, Mary Costello, Kenneth A Getz

Ther Innov Regul Sci· March 2023

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Evaluating the Feasibility and Validity of a New Tool to Assess Organizational Preparedness and Capabilities to Support Patient Engagement in Drug Development.
Debra L Michaels, Yaritza Peña, Barbara Lopez Kunz, Kenneth A Getz

Ther Innov Regul Sci· November 2021

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Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 2017.
Kenneth A Getz, Zachary P Smith, Yaritza Peña

Ther Innov Regul Sci· November 2020

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US Physician and Nurse Proclivity to Refer Their Patients Into Clinical Trials.
Kenneth A Getz

Ther Innov Regul Sci· March 2020

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Development Times and Approval Success Rates for Drugs to Treat Infectious Diseases.
Joseph A DiMasi, Maria I Florez, Stella Stergiopoulos, Yaritza Peña, Zachary Smith, Kenneth A Getz

Clin Pharmacol Ther· February 2020

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Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and Development.
Stella Stergiopoulos, Debra L Michaels, Barbara Lopez Kunz, Kenneth A Getz

Ther Innov Regul Sci· January 2020

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Evaluating the Completeness of ClinicalTrials.gov.
Stella Stergiopoulos, Kenneth A Getz, Christine Blazynski

Ther Innov Regul Sci· May 2019

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Insights and Best Practices for Planning and Implementing Patient Advisory Boards.
Annick Anderson, Kenneth A Getz

Ther Innov Regul Sci· July 2018

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Assessing the Financial Benefits of Faster Development Times: The Case of Single-source Versus Multi-vendor Outsourced Biopharmaceutical Manufacturing.
Joseph A DiMasi, Zachary Smith, Kenneth A Getz

Clin Ther· June 2018

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Cost Drivers of a Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Phase 3 Clinical Trial.
Stella Stergiopoulos, Sara B Calvert, Carrie A Brown, Josephine Awatin, Pamela Tenaerts, Kenneth A Getz

Clin Infect Dis· January 2018

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New Benchmarks Characterizing Growth in Protocol Design Complexity.
Kenneth A Getz, Rafael A Campo

Ther Innov Regul Sci· January 2018

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Examining and Enabling the Role of Health Care Providers as Patient Engagement Facilitators in Clinical Trials.
Kenneth A Getz

Clin Ther· November 2017

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Analysis of Review Times for Recent 505(b)(2) Applications.
Sharon Sakai, Joseph A DiMasi, Kenneth A Getz

Ther Innov Regul Sci· September 2017

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Trial watch: Trends in clinical trial design complexity.
Kenneth A Getz, Rafael A Campo

Nat Rev Drug Discov· May 2017

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A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals.
Stella Stergiopoulos, Carrie A Brown, Thomas Felix, Gustavo Grampp, Kenneth A Getz

Drug Saf· November 2016

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Mobile Nurse Services in Clinical Trials: Usage and Industry Perceptions.
Stella Stergiopoulos, Conor Eustace, Komathi Stem, Kenneth A Getz

Ther Innov Regul Sci· July 2016

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The Impact of Protocol Amendments on Clinical Trial Performance and Cost.
Kenneth A Getz, Stella Stergiopoulos, Mary Short, Leon Surgeon, Randy Krauss

Ther Innov Regul Sci· July 2016

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Generational Value Differences Affecting Public Perceptions of and Willingness to Participate in Clinical Trials.
April M Nelson, Irwin G Martin, Kenneth A Getz

Ther Innov Regul Sci· November 2015

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An Examination of eClinical Technology Usage and CDISC Standards Adoption.
Mary Jo Lamberti, Rebecca Kush, Wayne Kubick, Cindy Henderson, Brooke Hinkson, Kenneth A Getz

Ther Innov Regul Sci· November 2015

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An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals.
Stephanie Krumholz-Bahner, Mimmo Garibbo, Kenneth A Getz, Beat E Widler

Ther Innov Regul Sci· November 2015

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Establishing Return-on-Investment Expectations for Patient-Centric Initiatives.
Kenneth A Getz

Ther Innov Regul Sci· September 2015

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Identifying and Quantifying the Accuracy of Product Name Attribution of US-Sourced Adverse Event Reports in MedWatch of Somatropins and Insulins.
Stella Stergiopoulos, Carrie A Brown, Gustavo Grampp, Thomas Felix, Kenneth A Getz

Ther Innov Regul Sci· September 2015

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