Measuring the Incidence, Causes, and Repercussions of Protocol Amendments
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The implementation and communication of amendments is burdensome and potentially costly.
“The implementation and communication of amendments is also burdensome and potentially costly.474”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [474]
Reviews of pharmaceutical industry trials found that a third to a half of amendments could have been avoided with greater attention to key problems in the protocol.
“While some amendments may be unavoidable, reviews of pharmaceutical industry trials found that a third to a half of amendments could have been avoided with greater attention to key problems in the protocol.35 474”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [474]
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- Authors
- Getz, K. A., Zuckerman, R., Cropp, A. B., Hindle, A. L., Krauss, R., & Kaitin, K. I.
- Affiliations
- Tufts University (US)
- Pfizer (United States) (US)
- Biogen (United States) (US)
- Corresponding author
- Getz, Kenneth A.
- Venue
- Drug Information Journal
- Published
- 2011-05
- Volume
- 45
- Issue
- 3
- Pages
- 265-275
- ISSN
- 0092-8615 (ISSN-L)
- 2164-9200
- OpenAlex
- W2010816763
- Cited by
- 76
- References
- 3
- Citations by year
- 2026: 4 · 2025: 2 · 2024: 5 · 2023: 4 · 2022: 7 · 2021: 13 · 2020: 7 · 2019: 3 · 2018: 2 · 2017: 4 · 2016: 4 · 2015: 6 · 2014: 4 · 2013: 7 · 2012: 3
- FWCI
- 3.93
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Drug Information Journal (publishedVersion)
- Funders
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- Astellas Pharma
- Genentech
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- drug development, clinical trial efficiency, trial delays, research costs, pharmaceutical industry
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