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The Impact of Covid-19 on Clinical Trials


When COVID-19 took the world by storm and was declared a global health emergency by the World Health Organization (WHO), several countries went under strict lockdown while others imposed restrictions on movement to mitigate the spread of the novel coronavirus. There’s no denying the fact that this has been the only strategy known to work against this new global health threat. However, it has been creating problems in other areas of health. On the one hand, the novel coronavirus has made it difficult to provide healthcare services to patients suffering from other chronic diseases. On the other hand, it has created obstacles in clinical research and trails for a myriad of other diseases.

How COVID-19 Has Impacted Clinical Trials


The novel coronavirus has impacted clinical trials for other diseases in a number of ways. However, they can broadly be divided into the following two categories:

· Pausing and Postponement of Trials


Several pharmaceutical companies and clinical trial institutions were forced to stop their ongoing trials and postpone the ones that were in the pipeline due to the spread of COVID-19. There are three key reasons for this:


I. As countries went under lockdown, the participants of ongoing trials were also forced to stay at home. As a result, they couldn’t continue to participate in the trials they were part of, and the researchers were left with no option than to put the ongoing trials on hold.


II. As the novel coronavirus started displaying exponential growth, it caused the shortage of healthcare staff in many parts of the world. This pushed several healthcare facilities to shut down clinical trials and divert their staff members to join healthcare frontliners.


III. The spread of the virus also spurred new clinical research and testing. Since the new virus is contagious and can even be fatal, there is an urgent need to find potential treatments to cure the disease and curb its growth. This requires researchers to fast-track everything, from clinical research to lab testing to clinical trials, and hence, has caused a major shift in focus in the biomedical, clinical research and trials.


The companies that have paused and postponed clinical trials from March onwards include some of the big names in the pharmaceutical industry. They include Pfizer, Eli Lilly, Bristol-Myers, Squibb, Provention Bio, Inc., and Addex Therapeutics. According to a research report issued by Universitätsmedizin Berlin, Germany, about 1099 trials were paused or postponed between January 12 and May 5 due to the pandemic.[1]


· Reduced Enrollments


Medidata Solutions, a company that creates software for clinical trials, has been closely monitoring and analyzing the impact of the novel coronavirus on clinical trials. The company has been surveying 182,000 research and testing sites, all over the world, and 4,600 hundred ongoing clinical trials. So far, the company has released seven reports, with first released at the end of March and the latest one being released on July 13.[2]


According to Medidata reports, there has been a significant decline in the number of new enrollments for research studies and trials ever since the pandemic started. In March, the company observed, the world saw an average of 65% decrease in enrollments in clinical trials. In the United States, the decline was about 67%.[3]


The difference was calculated on a year-over-year basis.


However, as life has started to return to normalcy in several parts of the world, the percentage has dropped to 30% as of Medidata’s latest report (the company used October 31 as the pre-COIVD baseline for comparison).[4]


Conclusion


Despite the fact that the latest Medidata data has shown some improvements in the enrollment rate for clinical trials, the company has predicted that COVID-19 is likely to continue impacting trials for a long time (though with varying forces in different parts of the world).


Ana Nicholls, Managing Editor of the Industry Briefing at The Economist Intelligence Unit, has also warned healthcare researchers regarding the persistence of COVID-19 on clinical trials. “It’s unlikely that trials will get back up to full speed quickly,” she said.[5]


In such a scenario, we can only hope and pray for the world to get out of this pandemic soon; before it leads to serious problems in other areas of healthcare.


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