The Effect of COVID-19 on Clinical Research Sites

COVID-19 has affected all of us; our daily routines have changed, social interactions have been limited, and businesses have suffered. With a network of over sixty clinical research sites in the United States, Mexico, and Honduras, we would like to share how the clinical research industry is faring from the sites’ perspective.

Patient Enrollment During COVID-19

In studies where patients were already enrolled in the trial, our sites have been able to retain those subjects and work around the social-distancing and stay-in-place orders. This has been done mainly by scheduling only one patient at a time, as well as limiting staff numbers to the minimum required to perform the assessments. In some cases—where the sponsor has approved the process—sites have been able to organize home visits, rather than having study participants attend the site, thereby minimizing the subject’s exposure to COVID-19. Due to these measures, we believe that patient retainment will not be as negatively affected as initially forecast.

However, we have seen a dramatic drop in new patient recruitment. To avoid this negative trend, sites and sponsors need to make a combined effort to increase awareness of both the trial and the safety measures and precautions taken on-site to avoid the spread of COVID-19. Study protocols will also need to take into consideration the new social-distancing norms so that the site finds it easier to implement social distancing into their workflow and patient visits. Furthermore, home visits may need to be considered for special at-risk populations.

Site Initiation Visits and Monitorizations [MH1] Go Live

Various sponsors decided that rather than delay their study start-ups and routine monitorizations [MH2] , they would perform these activities remotely with the use of video-conferencing systems. This has been a demanding and challenging change for many of our sites that has required additional staff support, time, and investment in tech infrastructure. Yet it has been a great success and may very well end up becoming the new industry norm. Taking these routine visits online optimizes costs, reduces travel, and saves staff time. This may, in fact, be our own industry trial into how effective and efficient remote monitoring and visits can be.

COVID-19 has definitely impacted and changed all of our lives, we hope that
many of those changes will slowly dissipate once we have better epidemiological insight, a therapeutic response to the virus that proves to be effective, and a vaccine.

Telemedicine anyone?

Yes, some sponsors have decided to pave the way with telemedicine and conduct patient assessments remotely. We have heard of sites that are extremely satisfied with these trials, and while we do not have a site currently participating in one, we look forward to the experience.

Technology confers the possibility of minimizing health risks while optimizing costs in the long run, yet it does not come without its challenges. One of the main challenges is that it only optimizes costs in the long run. At first, it represents a large capital expenditure, which places a large burden on sites. Sponsors could eventually take the lead and facilitate the technology needed for running their trial; however, this simply shifts the burden. A good compromise may be that the equipment purchased by the sites and used to run the trial is leased by the sponsor during the trial. This could make the CAPEX worth it for sites while lowering sponsor OPEX.

On Hold

One of the most detrimental industry trends due to COVID-19 is the number of studies being placed on hold. Percentage-wise, we could easily say that we have seen a 40 percent increase in studies being placed on hold. This is probably the industry trend that most worries our sites.

Payment D E L A Y S

There is always quite a contentious view on payments—sites constantly complain about delays. However, now with the reshuffling that working remotely has thrust upon us, there have been additional delays in payments. This, we hope, is not a lasting trend. We are confident that once we can work out the glitches of working remotely and with the support from the array of payment automation tools, we will see payments resume their regular intervals.

In a Nutshell

COVID-19 has definitely impacted and changed all of our lives. We hope that many of those changes will dissipate once we have better epidemiological insight, a therapeutic response to the virus that proves to be effective, and a vaccine. However, some of the changes we have been forced to make may very well prove to be a better way forward, so learning to adapt and work around today’s challenges may help successfully position us for our post-COVID-19 world.

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