A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data
Author:
Funder
U.S. Food and Drug Administration
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Link
https://link.springer.com/content/pdf/10.1007/s43441-023-00595-1.pdf
Reference9 articles.
1. Smith Z, Bilke R, Pretorius S, et al. Protocol design variables highly correlated with, and predictive of, clinical trial performance. Ther Innov Regul Sci. 2022;56:333–45. https://doi.org/10.1007/s43441-021-00370-0.
2. Getz K, Campo R. New benchmarks characterizing growth in protocol design complexity. Ther Innov Regul Sci. 2018;52(1):22–8.
3. Rosenblatt M. The large pharmaceutical company perspective. N Engl J Med. 2017;376:52–60.
4. Getz K, Wenger J, Campo RA, et al. Assessing the impact of protocol design changes on clinical trial performance. Am J Ther. 2008;15(5):450–7. https://doi.org/10.1097/MJT.0b013e31816b9027.
5. Getz K, Smith Z, Kravet M. Protocol design and performance benchmarks by phase and by oncology and rare disease subgroups. Ther Innov Regul Sci. 2023;57(1):49–56.
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