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.
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
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