New FDA guidance on general clinical trial conduct in the era of COVID-19
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The FDA and NIH are calling for increased remote clinical outcomes to patient-generated measures, and the Covid-19 crisis is accelerating the appeal for remote monitoring in clinical trials.
“There is a wearable revolution in healthcare coming, with the FDA and National Institutes of Health (NIH) calling for increased remote clinical outcomes to patient-generated measures that do not require clinician oversight; the Covid-19 crisis is accelerating the appeal for remote monitoring in clinical trials [19].”
From Limiting racial disparities and bias for wearable devices in health science research (2020) · cites this paper as [19]
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- Authors
- Turner, J. R.
- Corresponding author
- Turner, J. Rick
- ORCID
- Turner, J. Rick
- Venue
- Therapeutic Innovation & Regulatory Science
- Published
- 2020-05-09
- Volume
- 54
- Issue
- 4
- Pages
- 723-724
- ISSN
- 2168-4790 (ISSN-L)
- 2168-4804
- PMC
- PMC7211045
- OpenAlex
- W3023908973
- Cited by
- 20
- References
- 11
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 3 · 2023: 3 · 2022: 2 · 2021: 6 · 2020: 2
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Therapeutic Innovation & Regulatory Science (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › COVID-19 and healthcare impacts
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Legal, Health, Environmental and COVID-19 Challenges
- Keywords
- COVID-19 pandemic, clinical trial conduct, FDA guidance, public health emergencies, medical supplies, regulatory policy, research ethics committees
- MeSH terms
- COVID-19, COVID-19 Testing, COVID-19 Drug Treatment, Clinical Trials as Topic, Humans, Pneumonia, Viral, United States, United States Food and Drug Administration, Coronavirus Infections, Clinical Laboratory Techniques, Pandemics
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