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Therapeutic Innovation & Regulatory Science|June 10, 2022
Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in EuropeZachary Smith, Emily Botto, Kenneth GetzTherapeutic Innovation & Regulatory Science|March 26, 2024
New Benchmarks on Protocol Amendment Experience in Oncology Clinical TrialsEmily Botto, Zachary Smith, Kenneth GetzTherapeutic Innovation & Regulatory Science|June 8, 2025
Trends in the Burden for Patients Participating in Industry-Funded Clinical TrialsAbigail Dirks, Emily Botto, Zachary Smith, et al.Therapeutic Innovation & Regulatory Science|March 4, 2024
New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial PerformanceKenneth Getz, Zachary Smith, Emily Botto, et al.Therapeutic Innovation & Regulatory Science|September 29, 2023
New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and BiologicsZachary Smith, Emily Botto, Otis Johnson, et al.Therapeutic Innovation & Regulatory Science|October 16, 2022
Insights from a Multi-company Workshop to Apply a Patient Participation Burden Algorithm to Protocol DataZachary Smith, Emily Botto, Christopher Carney, et al.Therapeutic Innovation & Regulatory Science|December 30, 2025
Insights Informing Strategies for Optimizing the Collection of Clinical Trial DataKenneth Getz, Emily Botto, Ana Calduch Arques, et al.Therapeutic Innovation & Regulatory Science|May 11, 2024
Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical TrialsZachary Smith, Kenneth GetzTherapeutic Innovation & Regulatory Science|December 1, 2023
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol DataZachary Smith, Kenneth GetzTherapeutic Innovation & Regulatory Science|August 12, 2022
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease SubgroupsKenneth Getz, Zachary Smith, Marcy KravetPageof 17