How COVID-19 has fundamentally changed clinical research in global health

Park, Jay; Mogg, Robin; Smith, Gerald E.; Nakimuli-Mpungu, Etheldreda; Jehan, Fyezah; Rayner, Craig R.; Condo, Jeanine; Decloedt, Eric; Nachega, Jean B.; Reis, Gilmar; Mills, Edward J.

doi:10.1016/s2214-109x(20)30542-8

Cited by 157 publications

(142 citation statements)

References 92 publications

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“…Undertaking smarter trials requires a thorough consideration of multiple candidate designs during the planning stage, ideally with the use of statistical simulations to weigh the efficiencies of different designs. Further discussion of adaptive trial designs and case studies are provided in the second 44 and fourth 45 papers of this Series.…”

Section: Current Landscape Of Trial Research In Global Healthmentioning

confidence: 99%

Urgently seeking efficiency and sustainability of clinical trials in global health

Park

Grais²,

Taljaard

et al. 2021

The Lancet Global Health

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This paper shows the scale of global health research and the context in which we frame the subsequent papers in the Series. In this Series paper, we provide a historical perspective on clinical trial research by revisiting the 1948 streptomycin trial for pulmonary tuberculosis, which was the first documented randomised clinical trial in the English language, and we discuss its close connection with global health. We describe the current state of clinical trial research globally by providing an overview of clinical trials that have been registered in the WHO International Clinical Trial Registry since 2010. We discuss challenges with current trial planning and designs that are often used in clinical trial research undertaken in low-income and middle-income countries, as an overview of the global health trials landscape. Finally, we discuss the importance of collaborative work in global health research towards generating sustainable and culturally appropriate research environments.

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Section: Current Landscape Of Trial Research In Global Healthmentioning

confidence: 99%

Urgently seeking efficiency and sustainability of clinical trials in global health

Park

Grais²,

Taljaard

et al. 2021

The Lancet Global Health

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“…In addition to continuous evaluation of UPMC internal analyses and controlled clinical trials, the COVID-19 Therapeutics Committee has evaluated the surge of COVID-19-related preprints and peer-reviewed publications that have emanated on an unprecedented scale throughout the pandemic. 24,25,26 This placed a premium on expertise in evaluating the merits of published information. While our committee recognized the benefits of and thus implemented steroids, remdesivir, and tocilizumab in selected COVID-19 patients, it refuted use of hydroxychloroquine despite its EUA, given the existing data.…”

Section: Discussionmentioning

confidence: 99%

A Learning Health System Approach to the COVID-19 Pandemic: System-Wide Changes in Clinical Practice and 30-Day Mortality Among Hospitalized Patients

McCreary

Kip

Bariola

et al. 2021

Preprint

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Introduction: Rapid, continuous implementation of credible scientific findings and regulatory approvals is often slow in large, diverse health systems. The COVID 19 pandemic created a new threat to this common 'slow to learn and adapt' model in healthcare. We describe how UPMC committed to a rapid learning health system (LHS) model to respond to the COVID 19 pandemic. Methods: An observational cohort study was conducted among 11,429 hospitalized patients from 22 hospitals (PA, NY) with a primary diagnosis of COVID 19 infection (March 19, 2020 to June 6, 2021). Sociodemographic and clinical data were captured from UPMC electronic medical record (EMR) systems. Patients were grouped into four time-defined patient 'waves' based on nadir of daily hospital admissions, with wave 3 (September 20, 2020 to March 10, 2021) split at its zenith due to high volume with steep acceleration and deceleration. Outcomes included changes in clinical practice (e.g., use of corticosteroids, antivirals, and other therapies) in relation to timing of internal system analyses, scientific publications, and regulatory approvals, along with 30-day rate of mortality over time. Results: Mean (SD) daily number of hospital admissions was 26 (28) with a maximum 7 day moving average of 107 patients. System wide implementation of the use of dexamethasone, remdesivir, and tocilizumab occurred within days of release of corresponding seminal publications and regulatory actions. After adjustment for differences in patient clinical profiles over time, each month of hospital admission was associated with an estimated 5% lower odds of 30 day mortality (adjusted OR = 0.95, 95% confidence interval: 0.92 to 0.97, p < .001). Conclusions: In our large LHS, near real-time changes in clinical management of COVID 19 patients happened promptly as scientific publications and regulatory approvals occurred throughout the pandemic. Alongside these changes, patients with COVID 19 experienced lower adjusted 30 day mortality following hospital admission over time.

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“…The fast-track development also raised several concerns on regulation and incentives related to clinical trials as well as R&D and vaccine security [4] , calling for intense collaboration [6] . So, it is urgent to discuss alternative models for vaccine R&D and production to guarantee equitable access in the current and future pandemics.…”

mentioning

confidence: 99%