Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov

Pundi, Krishna; Perino, Alexander C.; Harrington, Robert A.; Krumholz, Harlan M.; Turakhia, Mintu P.

doi:10.1001/jamainternmed.2020.2904

Cited by 68 publications

(59 citation statements)

References 3 publications

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“… 66 The situation is unlikely to change in the near future, as a review of ClinicalTrials.gov has identified a concerningly large proportion of studies with an expected low level of evidence. 67 Accordingly, a recent systematic review which examined 42 guidelines related to COVID-19 released in the spring/summer of 2020 found that the quality of all was poor, especially with respect to the rigour of their development. 68 The infodemic in scientific literature may result in a churn of studies that capture attention, but do not, and, arguably, should not, contribute meaningfully to clinical practice.…”

Section: The Infodemicmentioning

confidence: 99%

Implications of the COVID-19 Pandemic for Cardiovascular Disease and Risk-Factor Management

Lau

McAlister

2021

Canadian Journal of Cardiology

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COVID-19 and our public health responses to the pandemic may have far-reaching implications for cardiovascular risk affecting the general population and not just survivors of COVID-19. In this narrative review, we discuss how the pandemic may impact general cardiovascular risk for years to come, and explore the mitigating potential of telehealth interventions. From a health care perspective, the shift away from in-person office visits may have led many to defer routine risk factor management and may have had unforeseen effects on continuity of care and adherence. Fear of COVID-19 has led some patients to forego care for acute cardiovascular events. Curtailment of routine outpatient laboratory testing has likely delayed intensification of risk-factor modifying medical therapy, and drug shortages and mis-information may have negatively impacted adherence to antihypertensive, glucose-lowering, and lipid-lowering agents. From a societal perspective, the unprecedented curtailment of social and economic activities has led to income loss, unemployment, social isolation, decreased physical activity, and increased frequency of depression and anxiety, all of which are known to be associated with worse cardiovascular risk-factor control and outcomes. We must embrace and evaluate measures to mitigate these potential harms to avoid an epidemic of cardiovascular morbidity and mortality in the coming years that could dwarf the initial health impacts of COVID-19.

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Section: The Infodemicmentioning

confidence: 99%

Implications of the COVID-19 Pandemic for Cardiovascular Disease and Risk-Factor Management

Lau

McAlister

2021

Canadian Journal of Cardiology

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“…Understanding the cardiovascular response to SARS-CoV-2 re-infection and Influenza infection will be a particularly important area of research given the common theme in cardiovascular diseases, disorders and conditions of a "second hit phenomenon" that can accelerate pathological abnormalities and lead to clinical events. The bar must be set high to assure that research undertakings meet the vigorous standard needed to inform and advance the field [53].…”

Section: Research Platformsmentioning

confidence: 99%

Anticipating the long-term cardiovascular effects of COVID-19

Becker

2020

J Thromb Thrombolysis

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“…However, efforts to date have not managed to avoid research waste and ensure that all relevant studies contribute to the formulation of guidance and decisions in practice and policy 25. Most studies on covid-19 treatments have methodological limitations (eg, small samples and diverse designs and outcomes) 26. A sizeable portion of studies, collectively including thousands of patients, may therefore have little prospect of adding to the growing evidence base on efficacy.…”

Section: Progress On Research Coordination and Collaborationmentioning

confidence: 99%

Producing and using timely comparative evidence on drugs: lessons from clinical trials for covid-19

Naci

Kesselheim

Røttingen

et al. 2020

BMJ

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Since the early days of the novel coronavirus outbreak, a record number of studies have been launched to test several repurposed and new medicines as potential treatments for covid-19. 1 An analysis by the news organisation STAT identified over 1000 clinical trials registered on ClinicalTrials.gov between January and June 2020. 2 This is a testament to the research and clinical community's commitment to identify effective treatments for covid-19. However, the large volume of studies may paradoxically limit the generation of robust evidence and complicate the formulation of trustworthy guidance and decisions related to drug use if the current research is duplicative and redundant or produces conflicting data. 3-5 Indeed, the multiplicity of research on candidate therapeutics for covid-19 has exposed important flaws and failures in the current evidence ecosystem. 6 7 Crucially, these limitations also affect the full spectrum of research on new health technologies. 8 9 Users of evidence across the healthcare system (patients, clinicians, health technology assessment bodies, guideline developers, payers) need timely data on how different treatments compare with each other in terms of their benefits and harms-their comparative effectiveness. Producing comparative evidence and ensuring its rapid translation into trustworthy guidance requires extensive coordination and collaboration between the researchers conducting clinical trials, those conducting comparative effectiveness assessments, and those producing guidance. 8 9 The experience of covid-19 highlights the difficulties in making comparative assessments and suggests areas for improvement.

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Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov

Cited by 68 publications

References 3 publications

Implications of the COVID-19 Pandemic for Cardiovascular Disease and Risk-Factor Management

Implications of the COVID-19 Pandemic for Cardiovascular Disease and Risk-Factor Management

Anticipating the long-term cardiovascular effects of COVID-19

Producing and using timely comparative evidence on drugs: lessons from clinical trials for covid-19

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