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Preserving Clinical Trial Integrity During the Coronavirus Pandemic
JAMA ( IF 51.273 ) Pub Date : 2020-03-25 , DOI: 10.1001/jama.2020.4689
Mary M. McDermott; Anne B. Newman

Randomized clinical trials provide the highest-quality evidence for identifying therapies to help people attain longer and healthier lives. As of March 2020, ClinicalTrials.gov listed 262 366 ongoing randomized clinical trials, including 146 420 trials studying drug or biologic interventions, 85 045 trials of behavioral interventions, and 61 351 trials of surgical or device interventions.1 Suddenly, and quite dramatically, the coronavirus pandemic threatens the integrity of these clinical trials. The National Institutes of Health has advised investigators to consult with their institutional review boards and institutions about potential measures to protect participants and research staff. Responses from academic medical center and other research groups have varied from mandatory suspension of research involving human participants (except when this increases risk to participants) to relying on principal investigator discretion. Coronavirus mitigation efforts include self-isolation and avoiding health care centers where symptomatic patients congregate for medical care and where randomized trials are typically conducted. Mitigation efforts interfere with all aspects of a successful clinical trial: efficient accrual and randomization, intervention adherence and delivery, and outcome collection. Those most susceptible to severe consequences of coronavirus, older individuals and those with chronic disease, are commonly included in randomized trials designed to improve health in these vulnerable populations. When considering the risks and benefits of continuing clinical trials during the pandemic, one approach is to discontinue randomized trials that do not provide an immediate clear benefit to enrolled participants. However, benefits of therapeutic interventions in randomized trials are unknown until the trial is completed. Ongoing trials have potential to benefit millions of people with debilitating chronic diseases long after the coronavirus pandemic has ended. Furthermore, discontinuing ongoing trials wastes previously invested resources and squanders the time and effort of participants who may have already completed the trial. In contrast, sustaining ongoing trials could help millions of people realize substantial, durable health benefits that will be important once the coronavirus pandemic ends. Therefore, efforts and resources should be dedicated to support continuing randomized trials using creative and thoughtful methods and proactive planning. Adapting protocols to facilitate continued intervention adherence, outcome measurement, and some aspects of recruitment for trials already underway is likely to have the greatest benefit for the most people.
更新日期:2020-03-26

 

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