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Open AccessJournal ArticleDOI

Bringing New Meaning to the Term "Adaptive Trial": Challenges of Conducting Clinical Research During the Coronavirus Disease 2019 Pandemic and Implications for Implementation Science.

TLDR
Novel adaptive designs embedded into electronic health records (Embedded Quantified, Integrated-into-Practice Trial [EQuIPT] designs) that allow for easier and better access to clinical trials may simultaneously improve care and advance healthcare innovations.
Abstract
Although implementation of evidence-based practices takes an average of 17 years, in the context of the global pandemic, coronavirus disease 2019 (COVID-19) interventions were adopted in a greatly compressed time frame. This rapid uptake creates major challenges for conducting COVID-19 clinical research studies, because quickly evolving standards make it difficult to adapt in real time. The rapid dissemination and implementation of COVID-19 interventions is the realization of goals long pursued by the implementation science community. However, the downside of the rapid implementation is that low-quality evidence with little to no scientific vetting may be quickly integrated into clinical care, resulting in lost opportunities to advance our scientific understanding about how to manage infected patients. In the future, novel adaptive designs embedded into electronic health records (Embedded Quantified, Integrated-into-Practice Trial [EQuIPT] designs) that allow for easier and better access to clinical trials may simultaneously improve care and advance healthcare innovations.

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Journal ArticleDOI

Implementation of documented and written informed consent for clinical trials of communicable diseases: Lessons learned, barriers, solutions, future directions identified during the conduct of a COVID-19 clinical trial.

TL;DR: In this paper, the authors identify and evaluate processes that address these barriers while maintaining clinical and research staff safety, and identify and pilot-test several mechanisms for obtaining regulatory-compliant written informed consent during the COVID-19 therapeutics clinical trial.
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How Are Emerging Data Translated Into Clinical Practice? A Mixed Methods Investigation of Coronavirus Disease 2019 Institutional Treatment Protocols

TL;DR: In the early stages of the coronavirus disease 2019 (COVID-19) pandemic, there was minimal data to guide treatment, and clinicians lacked understanding of how clinicians translated this limited evidence base for potential therapeutics to bedside care as mentioned in this paper.
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Subcutaneous sarilumab for the treatment of hospitalized patients with moderate to severe COVID19 disease: A pragmatic, embedded randomized clinical trial

TL;DR: In this paper , a two-arm, randomized, open-label controlled trial comparing SOC alone to SOC plus sarilumab was conducted to measure the effectiveness of the subcutaneous anti-IL-6R antibody for clinical management of inpatients with moderate to severe COVID-19 disease.
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Reconsidering 'minimal risk' to expand the repertoire of trials with waiver of informed consent for research.

Paul A. Monach, +1 more
- 01 Sep 2021 - 
TL;DR: In this article, the authors identify clinical trial designs that confer minimal risk above that inherent in clinical care, to obviate the need for cumbersome consenting processes to enrol patients in prospective clinical research studies.
Journal ArticleDOI

Drug repurposing for COVID-19: current evidence from randomized controlled adaptive platform trials and living systematic reviews.

TL;DR: In this article , the authors show that Corticosteroids and immunomodulators that antagonize the interleukin-6 (IL-6) receptor play a critical role in modulating inflammation and improving clinical outcomes in hospitalized patients.
References
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Book

Diffusion of Innovations

TL;DR: A history of diffusion research can be found in this paper, where the authors present a glossary of developments in the field of Diffusion research and discuss the consequences of these developments.
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Diffusion of Innovations

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Diffusion Theory and Knowledge Dissemination, Utilization, and Integration in Public Health

TL;DR: This work compares diffusion, dissemination, and implementation with related notions that have served other fields in bridging science and practice and suggests ways to blend diffusion with other theory and evidence in guiding a more decentralized approach to dissemination and implementation in public health.
Journal ArticleDOI

What are pragmatic trials

TL;DR: The design of a pragmatic trial reflects variations between patients that occur in real clinical practice and aims to inform choices between treatments.
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