Cited by 20COVID-19 and healthcare impactsEthics in Clinical ResearchLegal, Health, Environmental and COVID-19 Challenges

New FDA guidance on general clinical trial conduct in the era of COVID-19

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Turner, J. Rick·2020·Therapeutic Innovation & Regulatory Science

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Crossref · 10.1007/s43441-020-00160-0

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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].”

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Authors
Turner, J. R.
Corresponding author
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
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
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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