The impact of COVID-19 on clinical research: the PIPPRA and MEDRA experience

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  • Louise Larkin
  • Tala Raad
  • Anusha Moses
  • Alexander Fraser
  • Stephen Gallagher
  • Esbensen, Bente Appel
  • Liam Glynn
  • Anne Griffin
  • Audrey C. Tierney
  • Norelee Kennedy

Background: Coronavirus disease 2019 (COVID-19) has had a significant impact on clinical research. This paper aims to provide an insight into how the COVID-19 pandemic, associated public health restrictions and international guidance on the conduct of clinical research impacted two clinical rheumatology research trials - the Physiotherapist-led Intervention to Promote Physical Activity in Rheumatoid Arthritis (PIPPRA) and the MEDiterranean diet in Rheumatoid Arthritis (MEDRA) projects. Methods: The March 2019 public health restrictions imposed to mitigate the risk of COVID-19 occurred at a time when PIPPRA was in the process of delivering assessment and intervention on a face-to-face basis (n=48) and MEDRA had commenced recruitment. Participants in PIPPRA and MEDRA had a diagnosis of rheumatoid arthritis, with some being immunosuppressed and thus at a higher risk for COVID-19. The decision-making processes of both trials is outlined to demonstrate the required amendments to continue in the context of the COVID-19 pandemic. Results: Amendments to PIPPRA and MEDRA trial protocols were agreed and received ethical and funder approval. Both trials switched from a face-to-face delivery to a telehealth using online platforms. The PIPPRA study was paused for five months (April-August 2020), resulting in n=33 (60%) negative deviations from assessment protocol. MEDRA switched from face-to-face to online recruitment with 20% (n=35/44) negative deviations in recruitment. Of the n=18 participants who consented to participating in a face-to-face trial, just n=2 (11%) opted to engage with telehealth delivery of the intervention. MEDRA assessment and intervention deviations were 100% as no sessions were completed as planned in 2020. Conclusions: The COVID-19 pandemic has severely impacted the PIPPRA and MEDRA clinical trials. Moving face-to-face clinical research to telehealth delivery may not be the panacea it is purported to be. Our experiences may be of benefit to researchers, clinicians, and funders in seeking to continue clinical research during a global pandemic.

OriginalsprogEngelsk
Artikelnummer55
TidsskriftHRB Open Research
Vol/bind4
Antal sider22
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
The two clinical research projects were the Physiotherapist-led Intervention to Promote Physical Activity in Rheumatoid Arthritis (PIPPRA) and the MEDiterranean diet in Rheumatoid Arthritis (MEDRA) projects. PIPPRA was a pilot randomised control feasibility study. The project was funded through the Health Research Board Definitive Intervention and Feasibility Awards 2018 (DIFA-2018-004). The MEDRA project was a pilot randomised control (RCT) study. Both projects were collaborations between the University of Limerick and University Hospitals Limerick Rheumatology department, with national and international collaborators from the healthcare, patient, research, and academic fields. Here the authors outline the impact of the COVID-19 pandemic on the PIPPRA and MEDRA projects, providing an insight into how the pandemic impacted two clinical research projects in rheumatology within an Irish context. This includes deviation from study protocols, where a protocol deviation is any departure from the study procedures or treatment plans as specified in the approved protocol ( ). This paper contributes to a very limited international body of literature on clinical research during the COVID-19 pandemic and seeks to inform academics, researchers, and clinicians about the considerations for conducting clinical research during a global pandemic. This paper aims to demonstrate how the COVID-19 pandemic, associated public health restrictions and international guidance on the conduct of clinical research impacted two clinical rheumatology research trials.

Funding Information:
Health Research Board Ireland [DIFA-2018-004] – PIPPRA. University of Limerick School of Allied Health PhD Scholarship – MEDRA.

Publisher Copyright:
Copyright: © 2023 Larkin L et al.

ID: 386370504