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

Lamberti MJ, Smith Z, Dirks A, Caruana T, Mitchell T, Getz K. Quantifying Protocol Deviation Experience by Clinical Phase. 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

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 M.J., 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