Publication Library & Research Findings

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Impact Report
New Anti-Infective Drugs Had 14% Speed Advantage vs. Other Drugs During 2000-19
September/October 2020
Research Article
Assessing Participation Burden in Clinical Trials: Introducing the Patient Friction Coefficient
Clinical Therapeutics
Kenneth Getz
8/1/2020
Impact Report
Faster New Drug Approval Phases Are More Than Offset By Longer Clinical Times in US
July/August 2020
Research Article
Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 2017
Therapeutic Innovation & Regulatory Science
Kenneth Getz, Zachary (Zak) Smith
6/18/2020
Research Article
Benchmarking Patient Recruitment and Retention Practices
Therapeutic Innovation & Regulatory Science
Mary Jo Lamberti, Kenneth Getz, Zachary (Zak) Smith
6/16/2020
Research Article
The Financial Benefits of Faster Development Times: Integrated Formulation Development, Real-Time Manufacturing, and Clinical Testing
Therapeutic Innovation & Regulatory Science
Joseph DiMasi
6/4/2020
Whitepaper
Drug Development Workforce in the Age of Digital Transformation
June 2020
Research Article
Benchmarking the Vendor Qualification Process
Therapeutic Innovation & Regulatory Science
Kenneth Getz
5/6/2020
Research Article
Assessing the Scope and Predictors of Intentional Dose Non-adherence in Clinical Trials
Therapeutic Innovation & Regulatory Science
Kenneth Getz, Zachary (Zak) Smith
5/4/2020
Impact Report
New Benchmarks Quantify Demographic Under-Representation in Clinical Trials
May/June 2020
Research Article
Establishing Consensus Understanding of the Barriers to Drug Development in Lupus
Therapeutic Innovation & Regulatory Science
Kenneth Getz
3/6/2020
Impact Report
Drug Developers Respond to Evolving Clinical Data Demands with New Strategies, Tactics
March/April 2020
Research Article
Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and Development
Therapeutic Innovation & Regulatory Science
Kenneth Getz
1/6/2020
Research Article
Assessing Patient Participation Burden Based on Protocol Design Characteristics
Therapeutic Innovation & Regulatory Science
Kenneth Getz
1/6/2020
Research Article
US Physician and Nurse Proclivity to Refer Their Patients Into Clinical Trials
Therapeutic Innovation & Regulatory Science
Kenneth Getz
1/6/2020
Impact Report
New Global Recruitment Performance Benchmarks Yield Mixed Results
January/February 2020
Research Article
Baseline Assessment of the Evolving 2017 eClinical Landscape
Therapeutic Innovation & Regulatory Science
Beth Harper, Kenneth Getz
12/31/2019
Impact Report
Vendor Qualification Process Volume and Complexity Require Substantial Time and Cost
November/December 2019
Whitepaper
Assessing the Financial Impact of Translational Pharmaceutics - A Platform for Accelerating Product Development
October 2019
Research Article
Development Times and Approval Success Rates for Drugs to Treat Infectious Diseases
Clinical Pharmacology & Therapeutics
Joseph DiMasi, Kenneth Getz, Zachary (Zak) Smith
9/10/2019
Impact Report
Cancer Drug Approvals Grew From 4% of US Total in the 1980s to 27% in 2010-18
September/October 2019
Research Article
A Study on the Application and Use of Artificial Intelligence to Support Drug Development
Clinical Therapeutics
Mary Jo Lamberti, Kenneth Getz
8/1/2019
Research Article
Assessing Biopharmaceutical Company Experience with Patient-centric Initiatives
Clinical Therapeutics
Mary Jo Lamberti, Kenneth Getz
8/1/2019
Research Article
What's Visible Is My Race, What's Invisible Is My Contribution: Understanding the Effects of Race and Color-Blind Racial Attitudes on the Perceived Impact of Microaggressions Toward Asians in the Workplace
Journal of Vocational Behavior
Jennifer Kim
8/1/2019
Commentary
Using Patient Advisory Boards to Solicit Input Into Clinical Trial Design and Execution
Clinical Therapeutics
Kenneth Getz
8/1/2019
Whitepaper
ALPHA Project Unites Global Lupus Community on Barriers to Research, Drug Development, Care, and Access
August 2019
Impact Report
Growth in Rare Disease R&D is Challenging Development Strategy and Execution
July/August 2019
Whitepaper
Summary Report From the Spring 2019 Executive Roundtable on Company Response to ICH E6 (R2)
July 2019
Research Article
Reflections on the Evolution of Patient Engagement in Drug Development
Pharmaceutical Medicine
Kenneth Getz
5/17/2019
Research Article
Assessing the Adoption of Clinical Trial Results Summary Disclosure to Patients and the Public
Expert Review of Clinical Pharmacology
Kenneth Getz
5/15/2019
Impact Report
Adoption of Artificial Intelligence is High Across Drug Development
May/June 2019
Impact Report
Outsourcing Outpaces Internal Spending But Remains Tactical and Reactive
March/April 2019
Research Article
Assessing Outsourcing Oversight Practices and Performance
Therapeutic Innovation & Regulatory Science
Beth Harper, Kenneth Getz
1/21/2019
Research Article
Global Consensus Building and Prioritisation of Fundamental Lupus Challenges; the ALPHA Project
Lupus Science and Medicine
Kenneth Getz
1/1/2019
Impact Report
US Continues to Lead New Drug R&D, But Asia-Pacific is Starting to Rise
January/February 2019
Research Article
The Use of Real World Evidence and Data in Clinical Research and Postapproval Safety Studies
Therapeutic Innovation & Regulatory Science
Mary Jo Lamberti, Kenneth Getz
12/30/2018
Impact Report
Global Biotech Product Development Continues Its Multi-Decade Surge
November/December 2018
Research Article
Global Public Attitudes About Clinical Research and Patient Experiences With Clinical Trials
JAMA Network Open
Kenneth Getz
10/5/2018
Book Chapter
The 360-Degree Experience of Workplace Microaggressions: Who Commits Them? How Do Individuals Respond? What Are the Consequences?
Microaggression Theory: Influence and Implications
Jennifer Kim
9/28/2018
Impact Report
CNS Drugs Take 20% Longer to Develop and to Approve vs. Non-CNS Drugs
September/October 2018
Research Article
Evaluating the Completeness of ClinicalTrials.gov
Therapeutic Innovation & Regulatory Science
Kenneth Getz
7/26/2018
Research Article
Trends Driving Clinical Trials Into Large Clinical Care Settings
Nature Reviews: Drug Discovery
Kenneth Getz
7/20/2018
Impact Report
Rising Protocol Complexity is Hindering Study Performance, Cost and Efficient
July/August 2018
Research Article
Assessing the Financial Benefits of Faster Development Times: The Case of Single-source Versus Multi-vendor Outsourced Biopharmaceutical Manufacturing
Clinical Therapeutics
Joseph DiMasi, Kenneth Getz, Zachary (Zak) Smith
6/1/2018
Impact Report
Patent-to-Launch Time for Orphan Drugs is 2.3 Years Longer vs. Other Drugs
May/June 2018
Commentary
Assessing Pharmaceutical Research and Development Costs
JAMA Internal Medicine
Joseph DiMasi
4/1/2018
Research Article
The Use of Real-World Evidence and Data in Clinical Research and Postapproval Safety Studies
Therapeutic Innovation & Regulatory Science
Mary Jo Lamberti, Kenneth Getz
3/28/2018
Research Article
Anticipating New Directions in Contract Clinical Outsourcing
Pharmaceutical Outsourcing
Kenneth Getz
3/20/2018
Impact Report
Clinical and Initiation Process Remains Lengthy and High Inefficient
March/April 2018
Research Article
Evaluating New Data-Driven Approaches Informing Global Investigative Site Selection
Pharmaceutical Outsourcing
2/10/2018