Impact of COVID-19 on clinical trials and clinical research: A systematic review
Brijesh Sathian,Brijesh Sathian,Mohammad Asim,Indrajit Banerjee,Ana Beatriz Pizarro,Bedanta Roy,Edwin van Teijlingen,Israel Júnior Borges do Nascimento,Israel Júnior Borges do Nascimento,Hanadi Khamis Alhamad +9 more
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TLDR
A systematic review of the literature aims to assess the impact of the coronavirus disease-19 pandemic on the conduction of clinical trials and research as mentioned in this paper, finding that most sites conducting clinical trials other than COVID-19 are experiencing a delay in timelines and a complete halt of operations in lieu of this pandemic, thus affecting clinical research outcomes.Abstract:
Background: The World Health Organization has reported more than 31,186,000 confirmed cases of coronavirus disease-19 (COVID-19), including 962,343 deaths, worldwide as on September 21, 2020. The current COVID-19 pandemic is affecting clinical research activities in most parts of the world. The focus on developing a vaccine for SARS-CoV-2 and the treatment of COVID-19 is, in fact, disrupting many upcoming and/or ongoing clinical trials on other diseases around the globe. On March 18, 2020, the United States Food and Drug Administration (FDA) issued an updated guideline for the conduct of clinical trials during the current health emergency situation. The potential challenges, such as social distancing and quarantines, result in study participants' inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up. Due to the sudden onset and wide-spread impact of COVID-19, its influence on the management of clinical trials and research necessitates urgent attention. Therefore, our systematic review of the literature aims to assess the impact of the COVID-19 pandemic on the conduction of clinical trials and research. The search for the relevant articles for review included the keywords "COVID-19" AND "clinical trial" in PubMed, MEDLINE, Embase, Google scholar and Google electronic databases. Key findings include: delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity. Globally, most sites conducting clinical trials other than COVID-19 are experiencing a delay in timelines and a complete halt of operations in lieu of this pandemic, thus affecting clinical research outcomes.read more
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Survey Fatigue During the COVID-19 Pandemic: An Analysis of Neurosurgery Survey Response Rates
Rosaline de Koning,Abdullah Egiz,Jay Kotecha,Ana Catinca Ciuculete,Setthasorn Zhi Yang Ooi,Nourou Dine Adeniran Bankole,Joshua Erhabor,George Higginbotham,Mehdi Khan,David Ulrich Dalle,Dawin Sichimba,Soham Bandyopadhyay,Ulrick Sidney Kanmounye +12 more
TL;DR: In this article, the authors analyzed the effect of the COVID-19 pandemic on neurosurgery surveys and their response rates, and suggested strategies for improving survey data collection, including population targeting, collaboration between research teams to minimize duplicate surveys, and communication with respondents to convey study importance.
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Uptake and effectiveness of a self-guided mobile app platform for college student mental health
TL;DR: In this paper , a mixed-methods study aims to examine the uptake and effectiveness of an implementation of IntelliCare for College Students, a self-guided app-based mental health platform, on two university campuses.
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Impact of the COVID-19 pandemic on statistical design and analysis plans for multidomain intervention clinical trials: Experience from World-Wide FINGERS
Susanne Röhr,Susanne Röhr,Hidenori Arai,Francesca Mangialasche,Nanae Matsumoto,Markku Peltonen,Rema Raman,Steffi G. Riedel-Heller,Takashi Sakurai,Heather M. Snyder,Taiki Sugimoto,Maria C. Carrillo,Miia Kivipelto,Mark A. Espeland +13 more
TL;DR: The authors of as mentioned in this paper report on experiences of three trials that, at various stages of conduct, altered designs and analysis plans to navigate these issues and provide recommendations for future trials to consider as they develop and launch behavioral intervention trials.
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TL;DR: The long-term effects of the turbulence caused by the pandemic have yet to be fully understood, but it should already be clear that the increased focus on participant needs and on the logistical challenges of current models are not likely to fade away quickly.
References
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Journal ArticleDOI
Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement
TL;DR: Moher et al. as mentioned in this paper introduce PRISMA, an update of the QUOROM guidelines for reporting systematic reviews and meta-analyses, which is used in this paper.
Journal Article
Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement [in Spanish]
David Moher,Alessandro Liberati,Jennifer Tetzlaff,Douglas G. Altman,Gerd Antes,David C. Atkins,Virginia Barbour,N Barrowman,Jesse A. Berlin,J Clark,Mike Clarke,Deborah J. Cook,Roberto D'Amico,Jonathan J Deeks,Philip J. Devereaux,Kay Dickersin,M Egger,E Ernst,P C Gøtzsche,Jeremy M. Grimshaw,G Guyatt,Julian P T Higgins,Ioannidis Jpa.,Jos Kleijnen,Tom Lang,N Magrini,D McNamee,Lorenzo Moja,C Mulrow,M Napoli,Andrew D Oxman,B Pham,Drummond Rennie,Margaret Sampson,Kenneth F. Schulz,Paul G. Shekelle,David Tovey,Peter Tugwell +37 more
Journal ArticleDOI
Telehealth for global emergencies: Implications for coronavirus disease 2019 (COVID-19).
Anthony C Smith,Emma Thomas,Centaine L. Snoswell,Helen M. Haydon,Ateev Mehrotra,Jane Clemensen,Jane Clemensen,Liam J Caffery +7 more
TL;DR: This article highlights key requirements for telehealth uptake, including flexible funding arrangements, training and accrediting the health workforce, to become a routinely used part of the health system.
Journal ArticleDOI
A Novel Coronavirus Emerging in China - Key Questions for Impact Assessment.
TL;DR: A Novel Coronavirus Emerging in China A novel coronavirus, designated as 2019-nCoV, emerged in Wuhan, China, at the end of 2019, although many details of the emergence of this virus remain unknown.
Journal ArticleDOI
COVID-19: what is next for public health?
David L Heymann,Nahoko Shindo +1 more
TL;DR: The WHO–UNICEF–Lancet Commission presents a candid assessment of the threats children face and the sombre implications for their future, and emphasises the role of community engagement in promoting the health and development of the world’s children.