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, D.L., Peña, Y., Kunz, B.L., 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