Novel Methods and Technologies for 21st-Century Clinical Trials: A Review
Open accessAbstract
IMPORTANCE: New technologies are rapidly reshaping health care. However, their effect on drug development to date generally has been limited. OBJECTIVES: To evaluate disease modeling and simulation, alternative study design, novel objective measures, virtual research visits, and enhanced participant engagement and to examine their potential effects as methods and tools on clinical trials. EVIDENCE REVIEW: We conducted a systematic search of relevant terms on PubMed (disease modeling and clinical trials; adaptive design, clinical trials, and neurology; Internet, clinical trials, and neurology; and telemedicine, clinical trials, and neurology), references of previous publications, and our files. The search encompassed articles published from January 1, 2000, through November 30, 2014, and produced 7976 articles, of which 22 were determined to be relevant and are included in this review. FINDINGS: Few of these new methods and technologies have been applied to neurology clinical trials. Clinical outcomes, including cognitive and stroke outcomes, increasingly are captured remotely. Other therapeutic areas have successfully implemented many of these tools and technologies, including web-enabled clinical trials. CONCLUSIONS AND RELEVANCE: Increased use of new tools and approaches in future clinical trials can enhance the design, improve the assessment, and engage participants in the evaluation of novel therapies for neurologic disorders.
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Episodic rather than continuous data recordings, collected under artificial conditions at certain study intervals, have been reported.
“Episodic rather than continuous data recordings, collected under artificial conditions at certain study intervals, have been reported45.”
From Wearable sensors during drawing tasks to measure the severity of essential tremor (2022) · cites this paper as [45]
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References 57 · Cited by 118
Research works printed but not linked: 4
- [19]Huntington Study Group Announcement of 2CARE early study closure [press release] 2014 http://www.huntington-study-group.org/LinkClick.aspx?fileticket=LurnlLVT3rw%3d&tabid=95. Accessed August 22, 2014
- [20]Huntington Study Group Announcement of CREST-E early study closure [press release] 2014 http://www.huntington-study-group.org/CurrentClinicalTrials/CRESTE/CRESTEOctober2014PressRelease/tabid/316/Default.aspx. Accessed November 19, 2014
- [37]The Michael J Fox Foundation and Intel join forces to improve Parkinson’s disease monitoring and treatment through advanced technologies [press release] https://www.michaeljfox.org/foundation/publication-detail.html?id=555&category=7. Accessed August 13, 2014
- [74]Christensen CM The Innovator's Dilemma: When New Technologies Cause Great Firms to Fail 1997 Harvard Business School Press Boston, MA
- Authors
- Dorsey, E. R., Venuto, C., Venkataraman, V., Harris, D. A., & Kieburtz, K.
- Affiliations
- University of Rochester Medicine (US)
- Duke University (US)
- Venue
- JAMA Neurology
- Publisher
- American Medical Association (AMA)
- Published
- 2015-05-01
- Volume
- 72
- Issue
- 5
- Pages
- 582
- ISSN
- 2168-6149 (ISSN-L)
- PMC
- PMC4708881
- OpenAlex
- W1969192849
- Cited by
- 118
- References
- 57
- Citations by year
- 2026: 4 · 2025: 11 · 2024: 13 · 2023: 9 · 2022: 7 · 2021: 10 · 2020: 16 · 2019: 11 · 2018: 14 · 2017: 10 · 2016: 8 · 2015: 5
- FWCI
- 10.98
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- JAMA Neurology (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (UL1TR000042)
- National Institute of Neurological Disorders and Stroke (P20NS092529, T32NS007338)
- National Center for Advancing Translational Sciences
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Keywords
- clinical trial design, disease modeling, simulation, adaptive trial design, telemedicine, participant engagement, cognitive outcomes, stroke outcome, drug development
- MeSH terms
- Clinical Trials as Topic, Humans, Nervous System Diseases, Neurology, Research Design
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