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Editorial
May 4, 2020

Randomized Clinical Trials and COVID-19: Managing Expectations

Author Affiliations
  • 1Editor in Chief, JAMA, Chicago, Illinois
  • 2Executive Editor, JAMA, Chicago, Illinois
JAMA. 2020;323(22):2262-2263. doi:10.1001/jama.2020.8115

Despite the millions of cases and hundreds of thousands of deaths that have occurred in this devastating coronavirus disease 2019 (COVID-19) pandemic, no peer-reviewed studies of specific therapies proven to be effective in reducing mortality have been published and a vaccine is many months to years away. To date, more than 1000 studies addressing various aspects of COVID-19 are registered on ClinicalTrials.gov, including more than 600 interventional studies and randomized clinical trials (RCTs).1 During the next few weeks and months, the results of numerous RCTs involving therapies for COVID-19 will be reported. Indeed, preliminary results from some studies have already been reported in social media and the popular press. How will clinicians, the public, and politicians understand the results of these much-anticipated and critically needed clinical trials?

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    2 Comments for this article
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    Challenges in Reporting COVID-19 Randomized Clinical Trials
    Aomesh Bhatt, MBBS, MRCGP | Dept of Paediatrics, University of Oxford
    While the outbreak of COVID-19 is intensifying and spreading globally, over 2100 clinical trials in over 120 countries have been registered on the WHO’s International Clinical Trials Registry Platform (ICTRP) [1]. The global urgency and intense pressure for effective treatments has led to many investigator-driven studies that use a range of primary outcome measures, many of which are underpowered for confirming efficacy. Variation in design and poor design characteristics will impede much of the research to be implemented as results might not be conclusive. The International Coalition of Medicines Regulatory Authorities (ICMRA) have agreed that randomized controlled trials (RCTs) with an appropriate control arm, appropriately designed to generate data that meet regulatory requirements for approval, could lead to timely regulatory decisions, and could guide clinicians in defining promptly the best treatment options for COVID-19 [2]. The International Committee of Medical Journal Editors (ICMJE) should be firmer in its proactive stance and guidance to ethics committees than simply relying on ethics approvals, which all small and uncontrolled studies will have. Additionally, as results from the trials start to report, the ICMJE could be best placed to evaluate the rigor of the ethics approvals obtained within the publication approval process.

    REFERENCES

    1. The WHO International Clinical Trials Registry Platform (ICTRP). Accessed May 5, 2020. https://www.who.int/ictrp/en/
    2. International Coalition of Medicines Regulatory Authorities (ICMRA). Accessed May 5, 2020. http://www.icmra.info/drupal/news/9April2020
    CONFLICT OF INTEREST: None Reported
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    Creating a Patient Database
    Marianne Gausche, MD | Harbor-UCLA Medical Center
    I agree with your conclusions in this article and feel this time provides a new way for us to approach research. Creating a patient database with specific questions that could be answered by physicians relative to their patients they are seeing would provide a large patient registry that could be used to answer some of the questions you mentioned in your article. Large observational cohorts could supply some of these data, that could then with certain rules be utilized by researchers to answer questions, such as whether hydroxychloroquine given early, prior to need for mechanical ventilation, prevents progression of disease. Other questions may be addressed given the large number of cases in the US including use of high flow nasal cannula versus early intubation, or other strategies such as proning. Large patient registries would have to have some safeguards such as privacy issues and assurances by physicians who entered data that it was accurate. However I feel the benefits far exceed the risks in developing such a database. Research needs to be more nimble. It also needs to be more inclusive of all the patients that are treated for a particular disease condition. It is time to consider additional ways we can answer questions beyond the RCT.
    CONFLICT OF INTEREST: None Reported
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