Fundamentals of clinical trial design

Evans, Scott R.

doi:10.6030/1939-067x-3.1.19

Cited by 119Statistical Methods in Clinical TrialsStatistical Methods in EpidemiologyEthics in Clinical Research

Fundamentals of clinical trial design

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Evans, Scott R.·2010·Journal of Experimental Stroke and Translational Medicine

DOI 10.6030/1939-067x-3.1.19PMC PMC3083073

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Abstract

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 cognitive-behavioural therapy will be included.
“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”
From Effectiveness and acceptability of cognitive-behavioural therapy based interventions for maternal peripartum depression: A systematic review, meta-analysis and thematic synthesis protocol (2019) · cites this paper as [59]
This problem is particularly acute in neurology, where outcomes may be highly variable, susceptible to the state of the patient, lack a gold standard definition or diagnosis, are high dimensional, or are composite in nature.
“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”
From QSAR without borders (2020) · cites this paper as [270]

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Additional file 9 of Effectiveness of cognitive behavioural therapy-based interventions for maternal perinatal depression: a systematic review and meta-analysis
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Additional file 16 of Effectiveness of cognitive behavioural therapy-based interventions for maternal perinatal depression: a systematic review and meta-analysis
Pettman, D., O’Mahen, H., Blomberg, O., Svanberg, A. S., von Essen, L., & Woodford, J. (2024) · Figshare · doi:10.6084/m9.figshare.26578853
Additional file 12 of Effectiveness of cognitive behavioural therapy-based interventions for maternal perinatal depression: a systematic review and meta-analysis
Pettman, D., O’Mahen, H., Blomberg, O., Svanberg, A. S., von Essen, L., & Woodford, J. (2024) · Figshare · doi:10.6084/m9.figshare.26578841
Additional file 4 of Effectiveness of cognitive behavioural therapy-based interventions for maternal perinatal depression: a systematic review and meta-analysis
Pettman, D., O’Mahen, H., Blomberg, O., Svanberg, A. S., von Essen, L., & Woodford, J. (2024) · Figshare · doi:10.6084/m9.figshare.26578814
Additional file 11 of Effectiveness of cognitive behavioural therapy-based interventions for maternal perinatal depression: a systematic review and meta-analysis
Pettman, D., O’Mahen, H., Blomberg, O., Svanberg, A. S., von Essen, L., & Woodford, J. (2024) · Figshare · doi:10.6084/m9.figshare.26578835

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)
DOI: 10.6030/1939-067x-3.1.19
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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