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Fundamentals of clinical trial design
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Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is crucial. Issues in trial conduct and analyses should be anticipated during trial design and thoughtfully addressed. Fundamental clinical trial design issues are discussed.
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“Only trial designs that allow for the isolation of the effects of CBT will be included given it is important for active comparators to discriminate intervention effects.59”
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“This problem is particularly acute in neurology, where outcomes may be highly variable (e.g., in cognition), susceptible to the state of the patient (e.g., fatigue, pain, anxiety, depression), the lack of a gold standard definition or diagnosis (e.g., neuropathy, dementia), are high dimensional (e.g., imaging or genomic markers), or are composite in nature (e.g., clinical instruments for assessing”
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Grünwald, V., Rußwurm, K., Eckert, R., Seseke, S., Standhaft, D., Hegemann, M., Baumann, S., Brenneis, H., Seidel, M., Rau, O., et al. (2025) · Cancers · doi:10.3390/cancers17243910
Pettman, D., O’Mahen, H., Blomberg, O., Svanberg, A. S., von Essen, L., & Woodford, J. (2024) · Figshare · doi:10.6084/m9.figshare.26578829
Pettman, D., O’Mahen, H., Blomberg, O., Svanberg, A. S., von Essen, L., & Woodford, J. (2024) · Figshare · doi:10.6084/m9.figshare.26578853
Pettman, D., O’Mahen, H., Blomberg, O., Svanberg, A. S., von Essen, L., & Woodford, J. (2024) · Figshare · doi:10.6084/m9.figshare.26578841
Pettman, D., O’Mahen, H., Blomberg, O., Svanberg, A. S., von Essen, L., & Woodford, J. (2024) · Figshare · doi:10.6084/m9.figshare.26578814
Pettman, D., O’Mahen, H., Blomberg, O., Svanberg, A. S., von Essen, L., & Woodford, J. (2024) · Figshare · doi:10.6084/m9.figshare.26578835
Metadata
- Authors
- Evans, S. R.
- Affiliations
- Harvard University (US)
- Corresponding author
- Evans, Scott R.
- ORCID
- Evans, Scott R.
- Venue
- Journal of Experimental Stroke and Translational Medicine
- Publisher
- OMICS Publishing Group
- Published
- 2010-01
- Volume
- 3
- Issue
- 1
- Pages
- 19-27
- ISSN
- 1939-067X (ISSN-L)
- PMC
- PMC3083073
- OpenAlex
- W2088245419
- Cited by
- 119
- References
- 20
- Citations by year
- 2026: 9 · 2025: 8 · 2024: 39 · 2023: 17 · 2022: 11 · 2021: 14 · 2020: 11 · 2019: 6 · 2018: 2 · 2016: 1 · 2013: 1
- FWCI
- 0.27
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Experimental Stroke and Translational Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- HAL (submittedVersion, cc-by)
- Funders
- National Institute of Allergy and Infectious Diseases (U01AI068634, UM1AI068634)
- National Institute of Neurological Disorders and Stroke (R01NS032228, U01NS032228)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Keywords
- clinical trial design, trial planning, design errors, trial conduct, statistical analysis planning, stroke research
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