Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance-Reference-Cited by-同舟云学术

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Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance

Published:2022-01-30 Issue:2 Volume:56 Page:333-345
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Smith Zachary^ORCID,Bilke Ralf,Pretorius Sybrand,Getz Kenneth

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/s43441-021-00370-0.pdf

Reference10 articles.

1. Getz K. Improving protocol design feasibility to drive drug development economics and performance. Int J Env Res Pub Health. 2014;11:5069–80.

2. Friedman L, Furberg C, DeMets D. Data collection and quality in the fundamentals of clinical trials. New York: Springer; 2010. p. 199–214.

3. Getz K, Campo R. New benchmarks characterizing growth in protocol design complexity. Ther Innov Re Sci. 2018;52(1):22–8.

4. Getz K, Stergiopoulos S, Marlborough M, Whitehill J, Curran M, Kaitin K. Quantifying the magnitude and cost of collecting extraneous protocol data. Am J Ther. 2015;22(2):117–24.

5. Kaitin K. Rising protocol design complexity is driving rapid growth in clinical trial data volume. Impact Rep. 2021; 23(1).

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1. New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance;Therapeutic Innovation & Regulatory Science;2024-03-04

2. Quantifying Site Burden to Optimize Protocol Performance;Therapeutic Innovation & Regulatory Science;2024-01-08

3. A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data;Therapeutic Innovation & Regulatory Science;2023-12-01

4. Assessing the Financial Value of Decentralized Clinical Trials;Therapeutic Innovation & Regulatory Science;2022-09-14

5. Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups;Therapeutic Innovation & Regulatory Science;2022-08-12

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