Prioritizing studies of COVID-19 and lessons learned

Jayaweera, Dushyantha; Flume, Patrick A.; Singer, Nora G.; Cohen, Myron S.; Lachiewicz, Anne; Cameron, Amanda; Thompson, Joel C.; Cabrera, Alyssa B.; Daudelin, Denise H.; Shaker, Reza; Bauer, Philippe R.

doi:10.1017/cts.2021.784

Cited by 8 publications

(16 citation statements)

References 25 publications

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“…The metrics show that NJ ACTS rose to the challenges posed by this pandemic and fulfilled its responsibilities as a CTSA recipient, by rapidly making notable process improvements to facilitate progress in clinical and translational research during this crisis. Importantly, there have been challenges and lessons learned that have provided unique opportunities for new processes to be put in place, many of which can lead to sustained improvements to benefit all studies going forward [6,7].…”

Section: Discussionmentioning

confidence: 99%

“…The NJ ACTS Clinical Trials Office (CTO) in collaboration with its Regulatory Core and its Participant and Clinical Interactions (PCI) Core formed committees that vetted the feasibility of proposed studies and prioritized COVID-19 studies for enrollment. The cores developed procedures that improved virtual operations for informed consent and implemented other opportunities to decentralize study procedures where practical [6,7]. The NJ ACTS Community Engagement Core pivoted to virtual platforms to increase enrollment in NJ ACTS-specific research and was able to engage community and healthcare organization partners to codesign and implement successful COVID-19 research design and recruitment strategies.…”

Section: Introductionmentioning

confidence: 99%

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The NJ Alliance for Clinical and Translational Science (NJ ACTS) experience: Responding at “warp speed” to COVID-19

Thaman

Tafuto

Gélinas

et al. 2022

J. Clin. Trans. Sci.

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Introduction: The COVID-19 pandemic’s need for life-saving treatments and a "warp speed" vaccine challenged the National Institutes of Health’s Clinical and Translational Science Award (CTSA) recipients to improve their methods and processes in conducting clinical research. While CTSA recipient, New Jersey Alliance for Clinical and Translational Science (NJ ACTS), responded to this call to action with significant clinical research milestones, a comprehensive understanding of regulatory metrics during the COVID-19 pandemic is uncertain. The objective of this research is to identify, compare, and contrast metrics that illustrate the effectiveness of NJ ACTS’s research mobilization efforts during COVID-19. Methods: Data were collected from the Institutional Review Board (IRB), the Clinical Research Units (CRUs), and the Office of Research and Sponsored Programs (ORSP). IRB data detailed the volume and types of protocols approved and turnaround time (TAT) for approval in 2020 vs. 2019. CRU data examined study metrics of adult and pediatric clinical trials across 2018-2020. ORSP data documented awards received in 2019 and 2020 Results: Analysis revealed a 95% increase in IRB-approved studies in 2020, with a significant decrease in TAT for COVID-19 studies. All CRUs observed a median 5.2-fold increase in the enrollment of adult and pediatric participants for COVID-19-related research. Study income was 106% and 196% greater than 2019 and 2018, respectively, with more than half funded through federal sponsors and 89% for COVID-19 trials. ORSP data revealed that 9% of awards and 26% of 2020 funding were COVID-19 studies. Conclusion: This study demonstrates that NJACTS effectively responded to challenges posed by the pandemic

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The NJ Alliance for Clinical and Translational Science (NJ ACTS) experience: Responding at “warp speed” to COVID-19

Thaman

Tafuto

Gélinas

et al. 2022

J. Clin. Trans. Sci.

View full text Add to dashboard Cite

show abstract

“…Centers established task forces and initiatives to guide, prepare, and support the healthcare institutions and research operations during an unprecedented crisis [10] with a goal to minimize the disruption imposed by the pandemic and to provide a swift and safe reactivation of research operations. While non-COVID-19 research paused, centers pivoted to implement COVID-19-specific studies [11].…”

Section: Policies To Protect Trainees and Staffmentioning

confidence: 99%

Managing the risks and benefits of clinical research in response to a pandemic

Flume

Berbari

Viera

et al. 2021

J. Clin. Trans. Sci.

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“…As this was a novel situation with challenges and potential opportunities for learning for future innovative clinical research practice, the current scoping review aimed to explore published evidence on innovative clinical research methods employed during COVID-19 to document challenges encountered and lessons that can be learned in the field of Speech-Language Pathology and Audiology. This study is also important because COVID-19 may last longer and perhaps precede other pandemics (Jayaweera et al, 2021 ).…”

Section: Introductionmentioning

confidence: 99%

Conducting clinical research in the era of the COVID-19 pandemic: Challenges and lessons for Speech-Language Pathology and Audiology research

Khoza-Shangase

Monroe

Sebothoma

2022

SAJCD

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Background: The novel coronavirus disease 2019 (COVID-19) presented new and unanticipated challenges to the academic training and performance of clinical research at undergraduate and postgraduate levels of training. This highlighted the need for reimagining research designs and methods to ensure continued generation of knowledge – a core function of a research-intensive university. Whilst adhering to government regulations geared towards protecting both the research participants and researchers, innovative research methods are required.Objective: The purpose of this scoping review is to explore published evidence on innovative clinical research methods and processes employed during COVID-19 and to document challenges encountered and lessons that the fields of Speech-Language Pathology and Audiology can learn.Methods: Electronic bibliographic databases including Science Direct, PubMed, Scopus, MEDLINE, ProQuest were searched to identify peer-reviewed publications, published in English, between 2019 and 2021, related to innovative clinical research methods and processes applied where in-person contact is regulated.Results: Significant challenges with conducting research in the COVID-19 era were identified, with important lessons learned and numerous opportunities that have relevance for this pandemic era and beyond. These findings are presented under 10 themes that emerged that highlight important considerations for research methods and processes during a pandemic and beyond. The findings of this study also raise implications for telehealth from which low- and middle-income countries (LMICs), where resource challenges exist, can benefit.Conclusion: Challenges and opportunities identified in this review have relevance for the field of Speech-Language Pathology and Audiology as far as current and future (beyond COVID-19) clinical research planning is concerned.

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Prioritizing studies of COVID-19 and lessons learned

Abstract: This version may be subject to change during the production process.

Cited by 8 publications

References 25 publications

The NJ Alliance for Clinical and Translational Science (NJ ACTS) experience: Responding at “warp speed” to COVID-19

The NJ Alliance for Clinical and Translational Science (NJ ACTS) experience: Responding at “warp speed” to COVID-19

Managing the risks and benefits of clinical research in response to a pandemic

Conducting clinical research in the era of the COVID-19 pandemic: Challenges and lessons for Speech-Language Pathology and Audiology research

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