Optimizing clinical research procedures in public health emergencies.

COVID-19 N-of-1 Public Health Emergency artificial intelligence clinical trial ethics master protocols platform studies randomized trials umbrella trial

Journal

Medicinal research reviews
ISSN: 1098-1128
Titre abrégé: Med Res Rev
Pays: United States
ID NLM: 8103150

Informations de publication

Date de publication:
03 2021
Historique:
received: 10 05 2020
revised: 14 10 2020
accepted: 22 10 2020
pubmed: 12 11 2020
medline: 11 3 2021
entrez: 11 11 2020
Statut: ppublish

Résumé

Public Health Emergencies of International Concern, such as the coronavirus disease 2019 pandemic, have a devastating impact on an individual and societal level, and there is an urgent need to learn, understand and bridge the therapeutic gap at a time of extreme stress on the patient, health care systems and staff. Well-designed, controlled clinical trials play a crucial role in the discovery of novel diagnostic and management strategies; however, these catastrophic circumstances pose unique challenges in initiating research studies at institutional, national, and international levels, highlighting the importance of a coordinated, collaborative approach. This review discusses key elements necessary to consider for developing clinical trials within a Public Health Emergency setting.

Identifiants

pubmed: 33174617
doi: 10.1002/med.21749
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

725-738

Informations de copyright

© 2020 Wiley Periodicals LLC.

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Auteurs

Ainhoa Madariaga (A)

Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.

Lawrence Kasherman (L)

Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.

Katherine Karakasis (K)

Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.

Pamela Degendorfer (P)

Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.

Ann M Heesters (AM)

Bioethics Program and The Institute for Education Research, University Health Network, University of Toronto, Toronto, Ontario, Canada.

Wei Xu (W)

Division of Biostatistics, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.

Shahid Husain (S)

Division of Infectious Disease, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada.

Amit M Oza (AM)

Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.

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