Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and lower-middle income critical care learning health system.
Diptesh AryalAbigail BeaneArjen M DondorpCameron GreenRashan HaniffaMadiha HashmiDevachandran JayakumarJohn C MarshallColin J McArthurSrinivas MurthySteven A WebbSubhash P AcharyaPramodya G P IshaniIssrah I JawadSushil KhanalKanchan KoiralaSubekshya LuitelUpulee PabasaraHem Raj PaneruAshok KumarShoaib Siddiq PatelNagarajan RamakrishnanNawal SalahuddinMohiuddin ShaikhTimo TolppaIshara UdayangaZulfiqar UmraniPublished in: Wellcome open research (2021)
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.
Keyphrases
- coronavirus disease
- sars cov
- phase iii
- phase ii
- clinical trial
- healthcare
- open label
- quality improvement
- primary care
- public health
- double blind
- study protocol
- high throughput
- placebo controlled
- respiratory syndrome coronavirus
- case report
- mental health
- physical activity
- palliative care
- randomized controlled trial
- virtual reality
- systematic review
- artificial intelligence
- electronic health record
- hepatitis c virus
- big data
- single cell
- chronic pain
- data analysis
- meta analyses
- community acquired pneumonia