The Serious Difficulties of Running a Clinical Trial During COVID-19 - COVID-19 Clinical Trial
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The Serious Difficulties of Running a Clinical Trial During COVID-19

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    The coronavirus has overshadowed nearly everything in its wake and created a singular focus on stopping the spread of infection. 

    But every issue important to Americans in the pre-coronavirus era still exists. Alzheimer’s is still ravaging the eldery, diabetes rates are still surging, and innocent children are still losing their lives to cancer. 

    For the scientists and researchers committed to studying potential drugs for these conditions in clinical trials, the COVID-19 pandemic has made an already difficult mission even harder. 

    Limited Funds and Resources

    Nearly every institution was forced to redirect its resources to battle the coronavirus in mid-March. Funds, resources, and essential employees, especially in the medical field, have no choice but to devote their full focus to stopping the spread of COVID-19 and treating at-risk patients. 

    In fact, many hospitals that serve as trial sites have been inundated with COVID-19 patients and are no longer available for clinical research use. Investigators have been pulled off their original projects and instructed to lead COVID-19 drug discovery trials or treat patients instead. 

    Reduced Access to Patients

    Necessary COVID-19 precautions are designed to slow the spread of infection, but they also make it much harder for clinical trial teams to access patients. This issue is manifesting itself in a variety of ways for the clinical trials still in progress:

    • Inability to perform initiation visits
    • Missed study visits 
    • Limitations on nonessential in-office visits or testing
    • Protocol adherence issues due to inability to comply with visit schedules
    • Variation in drug administration and monitoring procedures

    Clinical trials rely on carefully collected data using methods designed to minimize variables and maximize reliability. Reduced access to patients creates major challenges to consistent data collection, patient support, and other critical elements of any successful clinical trial. 

    Trials on Hold

    Since the beginning of March, nearly 100 companies have cancelled, rescheduled, delayed, or temporarily suspended planned and ongoing clinical trials. These companies announced such drastic disruptions to their clinical trials through press releases, SEC filings, and social media posts. 

    Back in March, large U.S drugmakers like Bristol Myers Squibb and Eli Lilly and Co reported delays to many of their planned clinical trials. Pharmaceutical giant Lexicon, meanwhile, cancelled two clinical trials that had just completed enrollment of nearly 15,000 type 2 diabetes patients. 

    It’s estimated that a total of 315 pivotal studies with more than 170,000 total subjects now risk being permanently terminated or remaining on hold for months or years due to COVID-19. This leaves vulnerable patients disappointed and frightened. 

    Neena Nizar, for example, thought 2020 would finally be the year her two sons received experimental treatment for their rare genetic disorder. “My son asks me all the time, ‘So when are we doing this trial? When can I? I don’t want to feel this pain anymore,’” she explained. “I feel like we were chugging along on a train and then somebody dropped a huge boulder on it.”

    Lung cancer researcher Roy Herbst agrees. He says clinical trials for cancer were cut to “almost zero” when the coronavirus outbreak began. “It’s hard to believe that just a month ago, I’d never seen cancer clinical trials better. Now the whole process has really ground to a halt, and I feel bad because there are patients who might have benefited from those trials.”

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