Publication Library & Research Findings

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Impact Report
Cost Variation and Mis-Estimation Characterize Clinical Trial Budgets, Particularly in Early Phases
March/April 2022
Book Chapter
Tufts Center for the Study of Drug Development Employs Broadly Engaged Team Science to Explore the Challenges of Pharmaceutical Research and Development
Broadly Engaged Team Science in Clinical and Translational Research
Kenneth Kaitin, Kenneth Getz
2/27/2022
Research Article
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance
Therapeutic Innovation & Regulatory Science
Kenneth Getz, Zachary (Zak) Smith
1/30/2022
Impact Report
The Incidence of Protocol Deviations and Amendments in Trials in High and Rising
January/February 2022
Research Article
Tracking Change in the Global Investigative Site Landscape
Applied Clinical Trials
Kenneth Getz
12/7/2021
Research Article
Debunking the ‘Model Minority’ Myth: How Positive Attitudes Towards Asian Americans Influence Perceptions of Racial Microaggressions
Journal of Vocational Behavior
Jennifer Kim
12/1/2021
Research Article
Discrimination Experienced By Asian Canadian and Asian American Healthcare Workers During the COVID-19 Pandemic: A Qualitative Study
Canadian Medical Association Journal Open
Jennifer Kim
11/16/2021
Research Article
Assessing Sponsor and CRO Awareness of Receptivity and Response to the Evolving Nature of Clinical Trial Patient Oversight
Applied Clinical Trials
Mary Jo Lamberti, Kenneth Getz
11/15/2021
Research Article
Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics
Therapeutic Innovation & Regulatory Science
Kenneth Getz, Zachary (Zak) Smith
11/1/2021
Impact Report
New Study Finds Site Personnel Race and Ethnicity Highly Correlated With Diversity of Patients Enrolled
November/December 2021
Research Article
Amplifying Patient Voices in Protocol Design
Applied Clinical Trials
Kenneth Getz
9/8/2021
Impact Report
Clinical Teams Working Remotely During the COVID-19 Pandemic Remain Highly Productive
September/October 2021
Research Article
Evaluating the Feasibility and Validity of a New Tool to Assess Organizational Preparedness and Capabilities to Support Patient Engagement in Drug Development
Therapeutic Innovation & Regulatory Science
Kenneth Getz
7/20/2021
Research Article
Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement
JAMA
Kenneth Getz
7/20/2021
Research Article
Remote Clinical Research Team Experience and Effectiveness During the COVID-19 Pandemic
Applied Clinical Trials
Mary Jo Lamberti, Kenneth Getz
7/13/2021
Impact Report
Biotech R&D Spending Grew By More Than 3X the Rate of Total Industry Spend in 2001-20
July/August 2021
Research Article
Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances
JAMA
Kenneth Getz
6/21/2021
Research Article
Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications
Therapeutic Innovation & Regulatory Science
Kenneth Getz
6/7/2021
Whitepaper
Summary of themes from the 2021 Executive Roundtable Examining Experiences Implementing and Accommodating the ICH E6 (R2) Guidance
June 2021
Research Article
Correction to: Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates
Therapeutic Innovation & Regulatory Science
Beth Harper, Kenneth Getz, Zachary (Zak) Smith
5/17/2021
Research Article
Cancer Trials Are Getting Harder to Complete, Suggesting a Role for More Powerful RWE, AI Solutions
The Cancer Letter
Kenneth Getz, Zachary (Zak) Smith
5/14/2021
Research Article
Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates
Therapeutic Innovation & Regulatory Science
Beth Harper, Kenneth Getz, Zachary (Zak) Smith
5/7/2021
Impact Report
Protocol Complexity and Patient Enrollment Intensify Challenge in Oncology Trials
May/June 2021
Research Article
Characterizing White Space in the Quest to Drive Development Speed
Applied Clinical Trials
Kenneth Getz
4/15/2021
Research Article
Anticipating Digital Transformation of the Drug Development Workforce
Pharmaceutical Executive
Kenneth Getz
3/26/2021
Research Article
A Survey of Survival Outcomes for Targeted Cancer Drugs Approved by the US Food and Drug Administration
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin
3/8/2021
Impact Report
Planned and Unplanned Mid-Study Updates Challenge Clinical Trial Timelines
March/April 2021
Research Article
Characterizing Data Management Challenges and their Impact
Applied Clinical Trials
Beth Harper, Kenneth Getz, Zachary (Zak) Smith
2/12/2021
Research Article
I’m Biased and So Are You. What Should Organizations Do? A Review of Organizational Implicit-Bias Training Programs
Consulting Psychology Journal: Practice and Research
Jennifer Kim
1/1/2021
Impact Report
Rising Protocol Design Complexity is Driving Rapid Growth in Clinical Trial Data Volume
January/February 2021
Research Article
Evolving Clinical Data Strategies and Tactics in Response to Digital Transformation
Therapeutic Innovation & Regulatory Science
Beth Harper, Kenneth Getz
9/14/2020
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