Publication Library & Research Findings

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Tufts CSDD Presents Focus Areas for Annual Research Pipeline Including Updating Cost of Drug Development
January 2023
Impact Report
Global Sites Optimistic About the Future of Clinical Trials Despite Ongoing Challenges
January/February 2023
Impact Report
Top CROs Gain Market Share, Close Record Number of M&A Deals, Improve Productivity
November/December 2022
Research Article
Insights from a Multi-company Workshop to Apply a Patient Participation Burden Algorithm to Protocol Data
Therapeutic Innovation & Regulatory Science
Kenneth Getz, Zachary (Zak) Smith
10/16/2022
Whitepaper
Benchmarking and Optimizing the Process for Adopting Innovations Supporting Clinical Trial Execution
October 2022
Research Article
How to Intervene When You Witness a Microaggression
Harvard Business Review
Jennifer Kim
9/30/2022
Research Article
Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity
Therapeutic Innovation & Regulatory Science
Maria Florez, Kenneth Getz
9/1/2022
Research Article
Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe
Therapeutic Innovation & Regulatory Science
Kenneth Getz, Zachary (Zak) Smith
9/1/2022
Impact Report
DCTs Substantially Increase Financial Value Based on Key Performance Indicators
September/October 2022
Research Article
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups
Therapeutic Innovation & Regulatory Science
Kenneth Getz, Zachary (Zak) Smith
8/12/2022
Research Article
The Impact of Decentralized and Hybrid Trials on Sponsor and CRO Collaborations
Applied Clinical Trials
Mary Jo Lamberti, Abigail Dirks, Kenneth Getz, Zachary (Zak) Smith
7/27/2022
Impact Report
Innovations Supporting Clinical Trial Execution Take Nearly Six Years to Adopt
July/August 2022
Research Article
Quantifying Protocol Deviation Experience by Clinical Phase
Applied Clinical Trials
Kenneth Getz
6/7/2022
Research Article
Strategic, Feasibility, Economic, and Cultural Aspects of Phase 0 Approaches: Is It Time to Change the Drug Development Process in Order to Increase Productivity?
Clinical and Translational Science
Joseph DiMasi
6/1/2022
Research Article
The Impact of Gender Microaggressions on Team Performance in Drug Development
Applied Clinical Trials
Jennifer Kim
5/19/2022
Impact Report
In Europe, Demographic Under-Representation in Clinical Trials Persists
May/June 2022
Research Article
Benchmarking Protocol Deviations and their Variation by Major Disease Categories
Therapeutic Innovation & Regulatory Science
Kenneth Getz, Zachary (Zak) Smith
4/4/2022
Research Article
Measuring Patient Satisfaction as a Primary Outcome for Patient-Centric Initiatives
Applied Clinical Trials
Jennifer Kim, Kenneth Getz
3/17/2022
Research Article
Tailoring the Intervention to the Self: Congruence Between Self-Affirmation and Self-Construal Eliminates the MBA Gender Performance Gap.
Organizational Behavior and Human Decision Processes
Jennifer Kim
3/1/2022
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