Mitigating the Effects of Nonadherence in Clinical Trials
Open accessAbstract
Accounting for subject nonadherence and eliminating inappropriate subjects in clinical trials are critical elements of a successful study. Nonadherence can increase variance, lower study power, and reduce the magnitude of treatment effects. Inappropriate subjects (including those who do not have the illness under study, fail to report exclusionary conditions, falsely report medication adherence, or participate in concurrent trials) confound safety and efficacy signals. This paper, a product of the International Society for CNS Clinical Trial Methodology (ISCTM) Working Group on Nonadherence in Clinical Trials, explores and models nonadherence in clinical trials and puts forth specific recommendations to identify and mitigate its negative effects. These include statistical analyses of nonadherence data, novel protocol design, and the use of biomarkers, subject registries, and/or medication adherence technologies.
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Platform failure is usually based on the inability to overcome barriers such as high complexity, issues with interoperability, and lack of technical robustness.
“On the contrary, the failure of a platform is usually based on the inability of overcoming several barriers, such as the high complexity, issues with interoperability, and lack of technical robustness.3”
From Design and Usability Assessment of a User-Centered, Modular Platform for Real-World Data Acquisition in Clinical Trials Involving Post-Bariatric Surgery Patients (2025) · cites this paper as [3]
The Methods section discusses interoperability between subject registries, and the Discussion discusses complexity of clinical-trial protocols. Neither passage addresses why platforms fail, and no passage found links platform failure to complexity, interoperability, or technical robustness (searched: platform failure, interoperability, technical robustness). (LLM, conf=0.76)
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References 48 · Cited by 114
Research works printed but not linked: 6
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- Authors
- Shiovitz, T. M., Bain, E. E., McCann, D. J., Skolnick, P., Laughren, T., Hanina, A., & Burch, D.
- Affiliations
- California Neuroscience Research Medical Group Sherman Oaks CA USA
- AbbVie (United States) (US)
- National Institutes of Health (US)
- Massachusetts General Hospital (US)
- AiCure (United States) (US)
- Pharmaceutical Product Development (United States) (US)
- Corresponding author
- Shiovitz, Thomas M.
- Venue
- The Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2016-01-22
- Volume
- 56
- Issue
- 9
- Pages
- 1151-1164
- ISSN
- 0021-9754 (ISSN-L)
- 0091-2700
- 1552-4604
- PMC
- PMC5066799
- OpenAlex
- W2194276201
- Cited by
- 114
- References
- 48
- Citations by year
- 2026: 4 · 2025: 10 · 2024: 12 · 2023: 7 · 2022: 16 · 2021: 10 · 2020: 23 · 2019: 13 · 2018: 8 · 2017: 7 · 2016: 4
- FWCI
- 5.64
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Journal of Clinical Pharmacology (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- medication non-adherence, protocol design, biomarkers, study power
- MeSH terms
- Clinical Trials as Topic, Female, Humans, Male, Patient Compliance, Patient Participation, Internationality, Medication Adherence
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