Postapproval Innovation For Oncology Drugs and the Inflation Reduction Act
Grabowski H, DiMasi J, Long G. Postapproval Innovation For Oncology Drugs and the Inflation Reduction Act. Health Affairs. October 8, 2024. Access article.
Trends in Patient Recruitment Advertising From 2012-2019
Zhang V, Getz K. Trends in Patient Recruitment Advertising From 2012-2019. Applied Clinical Trials. September 25, 2024. Access article.
Documenting the Last Mile Leak in the Patient Recruitment Pipeline.
Ralic D, Ford R, Monreal B, Vieyra K, Getz K. Documenting the Last Mile Leak in the Patient Recruitment Pipeline. DIA Global Forum. September 2024. Access article.
The Influence of Socioeconomic Status on Individual Attitudes and Experience with Clinical Trials
Kim, J.Y., Florez, M., Botto, E. et al. The Influence of Socioeconomic Status on Individual Attitudes and Experience with Clinical Trials. Nature. September 5, 2024. Access article.
Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials
Dirks A. Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials. PharmaFocus Asia. September 2024. Access article.
Assessing the Net Financial Benefits of Employing Digital Endpoints in Clinical Trials
DiMasi JA, Dirks A, Smith Z, et al. Assessing the Net Financial Benefits of Employing Digital Endpoints in Clinical Trials. Clin Transl Sci. July 28, 2024. Access article.
Mapping Strategies for Reaching Socioeconomically Disadvantaged Populations in Clinical Trials
Florez MI, Botto E, Kim JY. Mapping Strategies for Reaching Socioeconomically Disadvantaged Populations in Clinical Trials. JAMA. June 7, 2024. Access article.
How Much Does a Day of Delay in a Clinical Trial Really Cost
Getz K. How Much Does a Day of Delay in a Clinical Trial Really Cost?. Applied Clinical Trials. June 6, 2024. Access article.
Assessing the Net Financial Impacts of Employing Digital Endpoints in Clinical Trials
DiMasi J, Dirks A, Smith Z, Valentine S, Goldsack J, Metcalfe T, Grewal U, Leyens L, Conradi U, Karlin D, Maloney L, Getz K, Hartog B. Assessing the Net Financial Impacts of Employing Digital Endpoints in Clinical Trials. Clinical and Translational Science (revised; preprint server) Access article.
Back to (Communication) Basics: Reducing Site Burden & Establishing a Sponsor/CRO-of-Choice Relationship with Investigative Sites
Harper B, Getz K, Karcher T. Back to (Communication) Basics: Reducing Site Burden & Establishing a Sponsor/CRO-of-Choice Relationship with Investigative Sites. DIA Global Forum. May 31, 2024. Access Article.
Mapping Baseline ChaptGPT Usage to Support Drug Development
Kim JY, Ford RM, Shang Z. Mapping Baseline ChaptGPT Usage to Support Drug Development. Applied Clinical Trials. May 21, 2024. Access article.
New Estimates on the Cost of a Delay Day in Drug Development
Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials
Benchmarking Site Activation and Patient Enrollment
Lamberti M, Dirks A, Nicholas K, Cervantes N, Getz K. Benchmarking Site Activation and Patient Enrollment. Applied Clinical Trials. April 3, 2024. Access article.
New Benchmarks on Protocol Amendment Experience in Oncology Clinical Trials
Botto, E., Smith, Z. & Getz, K. New Benchmarks on Protocol Amendment Experience in Oncology Clinical Trials. TIRS. March 26, 2024. Access article.
An Examination of the Use of Patient Recruitment and Retention Tactics for Global Studies
Lamberti M, Dirks A, Nicholas K, Cervantes N, Getz K. An Examination of the Use of Patient Recruitment and Retention Tactics for Global Studies. Applied Clinical Trials. March 18, 2024. Access article.
Patient and Site Personnel Perceptions of Retail Pharmacy Involvement in Clinical Research
Botto E, Ford MR, Do H, Getz K. Patient and Site Personnel Perceptions of Retail Pharmacy Involvement in Clinical Research. Applied Clinical Trials. March 7, 2024. Access article.
Calling Out Check-the-Box Patient Engagement
Getz K. Calling Out Check-the-Box Patient Engagement. Applied Clinical Trials. March 2024.
General and Stereotype-Based Microaggressions Experienced by Asians and Asian Americans in the Workplace: A Qualitative Study
Nguyen DV, Block CJ, Kim JY, Yu H. General and Stereotype-Based Microaggressions Experienced by Asians and Asian Americans in the Workplace: A Qualitative Study. American Behavioral Scientist. March 1, 2024. Access article.
New Benchmarks on Protocol Amendment Practices, Trends and Their Impact on Clinical Trial Performance
Getz K, Smith Z, Botto E, Murphy E, Dauchy A. New Benchmarks on Protocol Amendment Practices, Trends and Their Impact on Clinical Trial Performance. TIRS. 2024. Access article.
Bridging the Recruitment Gap for Socioeconomically Disadvantaged Groups in Clinical Trials
Kim J, Florez M, Botto E, Bhagat R, Boynton K, Ferguson. Bridging the Recruitment Gap for Socioeconomically Disadvantaged Groups in Clinical Trials. Applied Clinical Trials. February 16, 2024. Access article.
Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials
Dirks A, Florez M, Torche F, Young S, Slizgi B, Getz K. Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials. TIRS. February 2024. Access article.
Quantifying Site Burden to Optimize Protocol Performance
Florez M, Smith Z, Olah Z, Martin M, Getz K. Quantifying Site Burden to Optimize Protocol Performance. TIRS. 2024. Access article.
Shining a Light on Inefficiencies in Protocol amendment Implementation
Getz K. Shining a Light on Inefficiencies in Protocol Amendment Implementation. Applied Clinical Trials. Published December 6, 2023. Access article.
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data
Smith Z, Getz K. A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data. Ther Innov Regul Sci. Published December 1, 2023. Access article.
Assessing Sponsor Attitudes Toward Retail Pharmacy Involvement in Clinical Trial Recruitment and Execution
Botto E, Ford RM, Do H, Getz K. Assessing Sponsor Attitudes Toward Retail Pharmacy Involvement in Clinical Trial Recruitment and Execution. Applied Clinical Trials. Published October 30, 2023. Access article.
Outsourcing Model Usage and its Relationship to Clinical Trial Performance
Lamberti MJ, Smith Z, DiPietro M, Barry J, Getz K. Outsourcing Model Usage and Its Relationship to Clinical Trial Performance. Applied Clinical Trials. Published October 12, 2023. Access article.
New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics
Smith Z, Botto E, Johnson O, Rudo T, Getz K. New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics. Ther Innov Regul Sci. Published September 29, 2023. Access article.
What Makes an Inclusive Leader
Zheng W, Kim JY, Kark R, Mascolo L. What Makes an Inclusive Leader. Harvard Business Review. Published September 27, 2023. Access article.
In Search of Attributes Predictive of Collaboration Effectiveness
Getz KA. In Search of Attributes Predictive of Collaboration Effectiveness. Applied Clinical Trials. Published online September 8, 2023. Access article
Benchmarking Organizational Patient Engagement Capabilities in Clinical Research
Kim JY, Maria Paula BA, Granville C, Getz KA. Benchmarking Organizational Patient Engagement Capabilities in Clinical Research. Ther Innov Regul Sci. Published online July 2023. Access articleIs Your Organization's Remote Work Strategy "Working"? Exploring the Impact of Employees' Attitudes Toward Flexible Work Arrangements on Inclusion and Turnover Intention
Kim JY, Dirks A. Is Your Organization’s Remote Work Strategy “Working”? Exploring the Impact of Employees’ Attitudes Toward Flexible Work Arrangements on Inclusion and Turnover Intention. Ther Innov Regul Sci. Published online July 17, 2023. Access articleApplying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment
Betcheva L, Kim JY, Erhun F, Oraiopoulos N, Getz K. Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment. Ther Innov Regul Sci. 2023 Jun 30. Access articleOptimizing the Process for Adopting DCT Solutions
Getz K. Optimizing the Process for Adopting DCT Solutions. Applied Clinical Trials. June 2023. Access articleIntroducing Paladin
DiBiaso V, Getz K, Miller B, et al. Introducing Paladin. Applied Clinical Trials. June 2023. Access articleWhat is Hindering the Drug and Development Industry from Achieving Diversity, Equity, and Inclusion in its Workforce?
Kim, J. Y., & Botto, E. (2023). What is hindering the drug development industry from achieving diversity, equity and inclusion in its workforce? Nature Biotechnology, 41(6), 878–879. Access articleBenchmarking Patient Engagement Capabilities and Preparedness of Drug Development Sponsors
Kim J, Bautista Acelas MP, Granville C, Getz K. Benchmarking patient engagement capabilities and preparedness of drug development sponsors. TIRS. June 19, 2023. Access articleAssessing the Financial Value of Decentralized Clinical Trials
DiMasi JA, Smith Z, Oakley-Girvan I, Mackinnon A, Costello M, Tenaerts P, Getz KA. Assessing the financial value of decentralized clinical trials. Therapeutic Innovation & Regulatory Science 2023 57:209-219 Access article
Racial and Ethnic Disparities in Pivotal Trial Supporting FDA-Approved and European Commission-approved Drugs
Smith Z, Botto E, Getz K. Racial and ethnic disparities in pivotal trials supporting FDA-approved and European Commission-approved drugs. BioPharm Report. Spring 2023; 30(1): 6-8. Access articleAssessing Investigative Site Personnel Diversity and its Relationship with Patient Enrollment Diversity
Getz K. Assessing investigative site personnel diversity and its relationship with patient enrollment diversity. BioPharm Report. Spring 2023; 30(1): 9-12. Access articleExamining the Impact of Exclusionary Behaviors on Team Dynamics
Kim J. Y., Botto E. Examining the Impact of Exclusionary Behaviors on Team Dynamics. Applied Clinical Trials, March 24, 2023. Access articleResearch: How Anti-Asian Racism Has Manifested at Work in the Pandemic
Kim J. Y., Shang Z. Research: How Anti-Asian Racism Has Manifested at Work in the Pandemic. Applied Clinical Trials, March 13, 2023. Access articleAssessing Investigative Site Outlook and Operating Experience Post-Pandemic
Dirks A., Harper B., Getz K. Assessing Investigative Site Outlook and Operating Experience Post-Pandemic. Applied Clinical Trials, March 7, 2023. Access articleRebooting the Statistic that 5% of Eligible Patients Participate in Clinical Trials
Getz K. Rebooting the statistic that 5% of eligible patients participate in clinical trials. Applied Clinical Trials, March 2, 2023. Access article
How to Intervene When You Witness a Microaggression
The Impact of Decentralized and Hybrid Trials on Sponsor and CRO Collaborations
Quantifying Protocol Deviation Experience by Clinical Phase
Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforce
Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity
Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe
The Impact of Gender Microaggressions on Team Performance in Drug Development
Benchmarking Protocol Deviations and their Variation by Major Disease Category
Strategic, feasibility, economic, and cultural aspects of Phase 0 approaches
Measuring patient satisfaction as a primary outcome for patient-centric initiatives
Tailoring the intervention to the self: Congruence between self-affirmation and self-construal eliminates the MBA gender performance gap
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance
I’m biased and so are you. What should organizations do? A review of organizational implicit-bias training programs
Tracking Change in the Global Investigative Site Landscape: New benchmarks uncover a maturing and globally-shifting market
Debunking the ‘model minority’ myth: How positive attitudes towards Asian Americans influence perceptions of racial microaggressions
Discrimination experienced by Asian Canadian and Asian American healthcare workers during the COVID-19 pandemic: A qualitative study
Assessing Sponsor and CRO Awareness of Receptivity and Response to the Evolving Nature of Clinical Trial Patient Oversight
Amplifying Patient Voices in Protocol Design
Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics
Evaluating the Feasibility and Validity of a New Tool to Assess Organizational Preparedness and Capabilities to Support Patient Engagement in Drug Development
Remote Clinical Research Team Experience and Effectiveness During the COVID-19 Pandemic
A survey of survival outcomes for targeted cancer drugs approved by the US Food and Drug Administration
Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances
Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates
Harper B, Smith Z, Snowdon J, DiCicco R, Hekmat R, Willis V, Weeraratne D, Getz K. Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates. Therapeutic Innovation & Regulatory Science. 2021 May 17. Access article
Cancer trials are getting harder to complete, suggesting a role for more powerful RWE, AI solutions
Clinical trials for oncology drugs are running into unique challenges as protocols become more complex and as the number of new investigational agents continues to outpace all other drugs, according to a recent study by Tufts University researchers. The Cancer Letter. 2021 May 14. Access article
The financial benefits of faster development times: integrated formulation development, real-time manufacturing, and clinical testing
DiMasi, JA, Wilkinson M. The financial benefits of faster development times: integrated formulation development, real-time manufacturing, and clinical testing. TIRS 2020;54(6):1453-1460. Access article
Characterizing White Space in the Quest to Drive Development Speed
Getz K. Characterizing White Space in the Quest to Drive Development Speed. Applied Clinical Trials, 2021; April 15. Access article
Anticipating Digital Transformation of the Drug Development Workforce
Florez M, and Getz K. Anticipating digital transformation of the drug development workforce. Pharmaceutical Executive, March 26. Access article
Characterizing Data Management Challenges and their Impact
Harper B, Smith Z, Snowdon J, DiCicco R, Rezzan H, Getz K. Characterizing Data Management Challenges and their Impact. Applied Clinical Trials 2021; 30 (1/2). Access article
Amplifying Patient Voices in Protocol Design
Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics
Evaluating the Feasibility and Validity of a New Tool to Assess Organizational Preparedness and Capabilities to Support Patient Engagement in Drug Development
Remote Clinical Research Team Experience and Effectiveness During the COVID-19 Pandemic
A survey of survival outcomes for targeted cancer drugs approved by the US Food and Drug Administration
Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances
Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates
Harper B, Smith Z, Snowdon J, DiCicco R, Hekmat R, Willis V, Weeraratne D, Getz K. Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates. Therapeutic Innovation & Regulatory Science. 2021 May 17. Access article
Cancer trials are getting harder to complete, suggesting a role for more powerful RWE, AI solutions
Clinical trials for oncology drugs are running into unique challenges as protocols become more complex and as the number of new investigational agents continues to outpace all other drugs, according to a recent study by Tufts University researchers. The Cancer Letter. 2021 May 14. Access article
The financial benefits of faster development times: integrated formulation development, real-time manufacturing, and clinical testing
DiMasi, JA, Wilkinson M. The financial benefits of faster development times: integrated formulation development, real-time manufacturing, and clinical testing. TIRS 2020;54(6):1453-1460. Access article
Characterizing White Space in the Quest to Drive Development Speed
Getz K. Characterizing White Space in the Quest to Drive Development Speed. Applied Clinical Trials, 2021; April 15. Access article
Anticipating Digital Transformation of the Drug Development Workforce
Florez M, and Getz K. Anticipating digital transformation of the drug development workforce. Pharmaceutical Executive, March 26. Access article
Characterizing Data Management Challenges and their Impact
Harper B, Smith Z, Snowdon J, DiCicco R, Rezzan H, Getz K. Characterizing Data Management Challenges and their Impact. Applied Clinical Trials 2021; 30 (1/2). Access article