[co-author: Martika Harper, MS.]

Photo by Satheesh Sankaran on Unsplash

The COVID-19 pandemic has had an immense impact on clinical trials in the US. Many clinical trials have been suspended or stopped due to the demands of the pandemic. Not only does interruption of these trials leave participants at a standstill with treatment, but it also negatively impacts other stakeholders like sponsors and researchers. The pandemic has put a damper on research funding as well as treatment options for at-risk participants. Many researchers and institutions have been impacted in three main areas: financial losses, having to redirect research focus, and adapting to a new clinical trial process.

Financial Losses

Many trials across the US were either halted or terminated altogether due to the COVID-19 pandemic. This means investigational products and supplies bought for these trials are going to waste, which has caused a number of institutions and centers to suffer a financial loss. The closure of labs and universities due to the pandemic has forced researchers to face the challenge of completing projects by their deadlines and paying their lab members once their grant funding dries up. Many of the lab members at these universities are graduate students and post-doctoral fellows that rely on stipends from grant funding to pay for day-to-day expenses such as housing and meals. Luckily there are a number of organizations like the US National Science Foundation (NSF) and the US National Institutes of Health (NIH) that are implementing measures to assist researchers during these trying times. Some of these measures include: extensions to due dates for progress reports, ability to apply for no-cost extensions to grants, acceptance of late grant applications, and allowing institutions affected by COVID-19 to continue to provide stipend payments to fellows and trainees.

Redirection of Focus

The COVID-19 pandemic has caused many researchers and clinicians to redirect their focus from non-COVID-19 trials to COVID-19 patients and research. The high number of COVID-19 cases across the US has overwhelmed critical care resources. Some clinicians have been pulled away from their clinical trials to help out in emergency rooms because of the disproportionate amount of staff to patient ratio due to COVID-19. To date, there are 4,397 COVID-19 trials listed in ClinicalTrials.gov, with 1002 of them being conducted in the US. Although clinical research has redirected the majority of its focus to COVID-19 for the time being, it has allowed for the rapid design and unveiling of COVID-19 trials. This in return has allowed for the quick response of drugs and vaccinations to combat the disease that has plagued our entire nation. The timeliness of COVID-19 clinical trials has made researchers realize that certain characteristics of clinical trials in general could be improved for a more streamlined process that would be beneficial to all stakeholders.

Adaptation of Trials

Since the pandemic started, the process of clinical trials has changed quite a bit. Due to social distancing, staff furloughs, and patient safety, investigators have had to come up with ways to continue their clinical research all while minimizing the risk of COVID-19 transmission. This has been extremely important since majority of clinical trials involve vulnerable populations that are at risk from COVID-19 exposure. The FDA released a guidance document (March 2020 and updated December 2020) recommending that certain considerations be in place to ensure the safety of trial participants, maintain compliance with good clinical practice, and minimize risks to trial integrity. To follow these considerations, many clinical trials have adopted the concept of remote technologies. This includes online informed consent process (eConsent), telemedicine like virtual patient visits to identify adverse events, and telehealth to measure objective outcome measures. Another way investigators have decreased the risk of exposure for trial participants is by offering direct-to patient courier services so that drugs are delivered to the participant’s home.

COVID-19 will more than likely have a long-lasting impact on clinical trials in the US. Although a lot of the impacts of COVID-19 on clinical trials have been negative, there is light at the end of the tunnel. Remote technologies such as telemedicine and telehealth have been around for many years, but institutions have been reluctant to use them because of cost and reimbursement issues. Due to COVID-19, maybe institutions will be more inclined to use remote technologies. COVID-19 has also allowed researchers to fine tune and modernize the clinical trial process which could help get products to market quicker.

References

COVID-19 Views. (n.d.). Retrieved from https://clinicaltrials.gov/ct2/covid_view

Dorn, A. V. (2020). COVID-19 and readjusting clinical trials. The Lancet, 396(10250), 523–524. doi:10.1016/s0140–6736(20)31787–6

FDA. (2020, December 4). Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency (United States, Food and Drug Administration, Office of Good Clinical Practice). Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency

Le Breton, S., Lamberti, M., Dion, A., & Getz, K. (2020, October 22). COVID-19 and Its Impact on the Future of Clinical Trial Execution [Web log post]. Retrieved from https://www.appliedclinicaltrialsonline.com/view/covid-19-and-its-impact-on-the-future-of-clinical-trial-execution

Stoye, E. (2020, April 17). How research funders are tackling coronavirus disruption [Web log post]. Retrieved from https://www.nature.com/articles/d41586-020-01120-2

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