Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and lower-middle income critical care learning health system.

LMICS Pandemic capacity building. clinical trials registry platform research network

Journal

Wellcome open research
ISSN: 2398-502X
Titre abrégé: Wellcome Open Res
Pays: England
ID NLM: 101696457

Informations de publication

Date de publication:
2021
Historique:
accepted: 15 01 2021
entrez: 19 2 2021
pubmed: 20 2 2021
medline: 20 2 2021
Statut: epublish

Résumé

The Randomized Embedded Multifactorial Adaptive Platform (REMAP-CAP) adapted for COVID-19) trial is a global adaptive platform trial of hospitalised patients with COVID-19. We describe implementation in three countries under the umbrella of the Wellcome supported Low and Middle Income Country (LMIC) critical  care network: Collaboration for Research, Implementation and Training in Asia (CCA). The collaboration sought to overcome known barriers to multi centre-clinical trials in resource-limited settings. Methods described focused on six aspects of implementation: i, Strengthening an existing community of practice; ii, Remote study site recruitment, training and support; iii, Harmonising the REMAP CAP- COVID trial with existing care processes; iv, Embedding REMAP CAP- COVID case report form into the existing CCA registry platform, v, Context specific adaptation and data management; vi, Alignment with existing pandemic and critical care research in the CCA. Methods described here may enable other LMIC sites to participate as equal partners in international critical care trials of urgent public health importance, both during this pandemic and beyond.

Identifiants

pubmed: 33604455
doi: 10.12688/wellcomeopenres.16486.1
pmc: PMC7883321
doi:

Types de publication

Journal Article

Langues

eng

Pagination

14

Subventions

Organisme : Wellcome Trust
Pays : United Kingdom
Organisme : Wellcome Trust
ID : 210599/Z/18/Z
Pays : United Kingdom

Informations de copyright

Copyright: © 2021 Aryal D et al.

Déclaration de conflit d'intérêts

No competing interests were disclosed.

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Auteurs

Diptesh Aryal (D)

Critical Care and Anaesthesia, Nepal Mediciti Hospital, Lalitpur, Bagmati Pradesh, 44600, Nepal.

Abi Beane (A)

Critical Care, Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Central Thailand, 10400, Thailand.
Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.

Arjen M Dondorp (AM)

Critical Care, Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Central Thailand, 10400, Thailand.
Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.

Cameron Green (C)

Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine Monash University, Melbourne, Victoria, Australia.

Rashan Haniffa (R)

Critical Care, Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Central Thailand, 10400, Thailand.
Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.

Madiha Hashmi (M)

Department of Critical Care, Ziauddin University, Karachi, Sindh, Pakistan.

Devachandran Jayakumar (D)

Chennai Critical Care Consultants, Chennai, Tamil Nadu, 600 040, India.
Critical Care Medicine, Apollo Specialty Hospital OMR, Chennai, Tamil Nadu, India.

John C Marshall (JC)

The Keenan Research Centre for Biomedical Science, St Michael's Hospital, Toronto, Ontario, Canada.

Colin J McArthur (CJ)

Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand.
Medical Research Institute of New Zealand, Wellington, New Zealand.

Srinivas Murthy (S)

Faculty of Medicine, University of British Columbia School of Medicine, Vancouver, British Columbia, Canada.

Steven A Webb (SA)

Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine Monash University, Melbourne, Victoria, Australia.
School of Medicine and Pharmacology, University of Western Australia, Crawley, Western Australia, Australia.
St John of God Hospital, Subiaco, Western Australia, Australia.

Subhash P Acharya (SP)

Critical Care Medicine, Tribhuvan University Teaching Hospital, Kathmandu, Bagmati Pradesh, 44600, Nepal.

Pramodya G P Ishani (PGP)

National Intensive Care Surveillance- MORU, Borella, Colombo, Western Province, 08, Sri Lanka.

Issrah Jawad (I)

National Intensive Care Surveillance- MORU, Borella, Colombo, Western Province, 08, Sri Lanka.

Sushil Khanal (S)

Critical Care Medicine, Grande International Hospital, Kathmandu, Bagmati Pradesh, 44600, Nepal.

Kanchan Koirala (K)

Critical Care and Anaesthesia, Nepal Mediciti Hospital, Lalitpur, Bagmati Pradesh, 44600, Nepal.

Subekshya Luitel (S)

Nepal Intensive Care Foundation, Kathmandu, Bagmati Pradesh, Nepal.

Upulee Pabasara (U)

National Intensive Care Surveillance- MORU, Borella, Colombo, Western Province, 08, Sri Lanka.

Hem Raj Paneru (HR)

Pulmonary and Critical Care, Hospital for Advanced Medicine and Surgery, Kathmandu, Bagmati Pradesh, Nepal.

Ashok Kumar (A)

Department of Chest Medicine and Critical Care, Ziauddin University, Karachi, Sindh, Pakistan.

Shoaib Siddiq Patel (SS)

South East Asian Research in Critical care and Health, Remedial Centre Hospital, Karachi, Sindh, Pakistan.

Nagarajan Ramakrishnan (N)

Critical Care Medicine, Apollo Specialty Hospital OMR, Chennai, Tamil Nadu, India.

Nawal Salahuddin (N)

Pulmonary & Critical Care Medicine, National Institute of Cardiovascular Diseases, Karachi, Sindh, Pakistan.

Mohiuddin Shaikh (M)

South East Asian Research in Critical care and Health, Remedial Centre Hospital, Karachi, Sindh, Pakistan.

Timo Tolppa (T)

National Intensive Care Surveillance- MORU, Borella, Colombo, Western Province, 08, Sri Lanka.

Ishara Udayanga (I)

National Intensive Care Surveillance- MORU, Borella, Colombo, Western Province, 08, Sri Lanka.

Zulfiqar Umrani (Z)

Office of Research, Innovation & Commercialization (ORIC), Zuiddin University, Karachi, Pakistan.

Classifications MeSH