Articles — Tufts CSDD

Popular Culture and Clinical Research Literacy

Getz K. Popular Culture and Clinical Research Literacy. Applied Clinical Trials. December 11, 2024. Access article.

Case for the Underdog: Unleashing the Potential for Small, Community-Based Research Sites

Kim J, Palmer E, Galindo J, Sfera D. Case for the Underdog: Unleashing the Potential for Small, Community-Based Research Sites. Applied Clinical Trials. December 5, 2024. Access article.

ROI and Rare Disease: Retooling the ‘Gene’ Value Machine

Blaustein M, Getz K. ROI and Rare Disease: Retooling the ‘Gene’ Value Machine. PharmExec. November 14, 2024. Access article.

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

Smith Z, DiMasi J, Getz K. New Estimates on the Cost of a Delay Day in Drug Development. TIRS. May 21, 2024. Access Article.

Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials

Smith Z, Getz K. Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials. TIRS. May 11, 2024. Access Article.

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 article

Is 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 article

Applying 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 article

Optimizing the Process for Adopting DCT Solutions

Getz K. Optimizing the Process for Adopting DCT Solutions. Applied Clinical Trials. June 2023. Access article

Introducing Paladin

DiBiaso V, Getz K, Miller B, et al. Introducing Paladin. Applied Clinical Trials. June 2023. Access article

What 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 article

Benchmarking 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 article

Assessing 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 article

Assessing 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 article

Examining 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 article

Research: 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 article

Assessing 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 article

Rebooting 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

Kim, J, Meister, A. How to Intervene When You Witness a Microaggression . Harvard Business Review. September, 30 2022. Access article

The Impact of Decentralized and Hybrid Trials on Sponsor and CRO Collaborations

Lamberti MJ, Smith Z, Dirks A, Caruana T, Mitchell T, Getz K. The Impact of Decentralized and Hybrid Trials on Sponsor and CRO Collaborations . Applied Clinical Trials. 2022. Access article

Quantifying Protocol Deviation Experience by Clinical Phase

Getz K. Quantifying Protocol Deviation Experience by Clinical Phase. Applied Clinical Trials. 2022; volume 32, issue 6. Access article

Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforce

Florez M, Botto E, Foster Z, Seltzer W, Valastro B, Ashmore L, Getz K. Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforce. Applied Clinical Trials. Access article

Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity

Getz K, Florez M, Botto E, Ribeiro K, Goller G, Robinson L, Abdullah O. Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity. TIRS. 2022. Doi.org/10.1007/243441-022-00418-9. Access article

Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe

Smith Z, Botto E, Getz K. Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe. TIRS. 2022. Doi.org/10.1007/s43441-022-00421-0. Access article

The Impact of Gender Microaggressions on Team Performance in Drug Development

Kim, JY & Botto, E. (2022). The Impact of Gender Microaggressions on Team Performance in Drug Development. Applied Clinical Trials. Access article

Benchmarking Protocol Deviations and their Variation by Major Disease Category

Getz K, Smith Z, Jain A, Krauss R. Benchmarking Protocol Deviations and their Variation by Major Disease Category. TIRS 2022. Access article

Strategic, feasibility, economic, and cultural aspects of Phase 0 approaches

Burt T, Roffel AD, Langer O, Anderson K, DiMasi JA. Strategic, feasibility, economic, and cultural aspects of Phase 0 approaches. Clinical and Translational Science 2022. Access article

Measuring patient satisfaction as a primary outcome for patient-centric initiatives

Kim, JY & Getz, K. (2022). Measuring patient satisfaction as a primary outcome for patient-centric initiatives. Applied Clinical Trials. Access article

Tailoring the intervention to the self: Congruence between self-affirmation and self-construal eliminates the MBA gender performance gap

Kim, JY, Brockner, J, & Block, CJ. (2022). 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, 169 (March). Access article

Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance

Smith Z, Bilke R, Pretorius S, Getz K. Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance. Therapeutic Innovation & Regulatory Science. (2022). Access article

I’m biased and so are you. What should organizations do? A review of organizational implicit-bias training programs

Kim, JY, & Roberson, L. 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. (2021). Access article

Tracking Change in the Global Investigative Site Landscape: New benchmarks uncover a maturing and globally-shifting market

Getz K. Tracking Change in the Global Investigative Site Landscape: New benchmarks uncover a maturing and globally-shifting market. Applied Clinical Trials. (2021). Access article

Debunking the ‘model minority’ myth: How positive attitudes towards Asian Americans influence perceptions of racial microaggressions

Kim, JY, Block, CJ, & Yu, H. Debunking the ‘model minority’ myth: How positive attitudes towards Asian Americans influence perceptions of racial microaggressions. Journal of Vocational Behavior (2021). Access article

Discrimination experienced by Asian Canadian and Asian American healthcare workers during the COVID-19 pandemic: A qualitative study

Shang, Z, Kim, JY, & Cheng, S O. Discrimination experienced by Asian Canadian and Asian American healthcare workers during the COVID-19 pandemic: A qualitative study. Canadian Medical Association Journal Open (2021). Access article

Assessing Sponsor and CRO Awareness of Receptivity and Response to the Evolving Nature of Clinical Trial Patient Oversight

Botto E, Lamberti MJ, Shah M, Getz K. Assessing Sponsor and CRO Awareness of Receptivity and Response to the Evolving Nature of Clinical Trial Patient Oversight. Applied Clinical Trials (2021). Access article

Amplifying Patient Voices in Protocol Design

Getz K. Amplifying Patient Voices in Protocol Design. Applied Clinical Trials (2021). Access article

Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics

Smith, Z; Wilkinson, M; Carney, C; Grove, N; Qutab, B; and Getz, K. Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics. TIRS (2021). Access article

Evaluating the Feasibility and Validity of a New Tool to Assess Organizational Preparedness and Capabilities to Support Patient Engagement in Drug Development

Michaels, DL, Peña, Y, Kunz, BL, Getz K. Evaluating the Feasibility and Validity of a New Tool to Assess Organizational Preparedness and Capabilities to Support Patient Engagement in Drug Development. TIRS (2021). Access article

Remote Clinical Research Team Experience and Effectiveness During the COVID-19 Pandemic

Florez M, Lamberti MJ, Getz K. Remote Clinical Research Team Experience and Effectiveness During the COVID-19 Pandemic. Applied Clinical Trials. Published Online. July 13, 2021. Access article

A survey of survival outcomes for targeted cancer drugs approved by the US Food and Drug Administration

Qian H, Qui L, Fanzhen L, Kaitin KI, Shao L. A survey of survival outcomes for targeted cancer drugs approved by the US Food and Drug Administration. TIRS 2021;55(4):676-684. Access article

Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances

Orkin A. et al. Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances. JAMA. Published online June 21, 2021. Access article

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