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.read more
Citations
More filters
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.
Patricia Woods,Maura Flynn,Paul A. Monach,Karen Visnaw,Sara Schiller,Erika Holmberg,Sarah Leatherman,Ryan Ferguson,Westyn Branch-Elliman +8 more
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.
Journal ArticleDOI
How Are Emerging Data Translated Into Clinical Practice? A Mixed Methods Investigation of Coronavirus Disease 2019 Institutional Treatment Protocols
Archana Asundi,Archana Asundi,Jack Resnik,Peter A. Benedict,Marlena H. Shin,A. Rani Elwy,A. Rani Elwy,Westyn Branch-Elliman,Westyn Branch-Elliman +8 more
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.
Journal ArticleDOI
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.
Journal ArticleDOI
Reconsidering 'minimal risk' to expand the repertoire of trials with waiver of informed consent for research.
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.
Yolanda Augustin,Henry M. Staines,Thirumalaisamy P. Velavan,Adeeba Kamarulzaman,Peter G. Kremsner,Sanjeev Krishna +5 more
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
More filters
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.
Journal ArticleDOI
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
Martin Roland,David J. Torgerson +1 more
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.
Journal ArticleDOI
Adaptive designs in clinical trials: why use them, and how to run and report them
Philip Pallmann,Alun Bedding,Babak Choodari-Oskooei,Munyaradzi Dimairo,Laura Flight,Lisa V. Hampson,Lisa V. Hampson,Jane Holmes,Adrian Mander,Lang’o Odondi,Matthew R. Sydes,Sofia S. Villar,James Wason,James Wason,Christopher J. Weir,Graham M. Wheeler,Graham M. Wheeler,Christina Yap,Thomas Jaki +18 more
TL;DR: This tutorial paper provides guidance on key aspects of adaptive designs that are relevant to clinical triallists, and emphasises the general principles of transparency and reproducibility and suggest how best to put them into practice.