Top Challenges Clinical Sites Are Facing
The current worldwide pandemic caused by the novel coronavirus, commonly known as COVID-19, has put the world of pharmaceutical clinical trials in a difficult spot.
On the one hand, with vaccines for the virus only recently being formulated, no definitive cure yet discovered, and treatment options limited, the importance of the clinical trial to pharmaceutical development has rarely been so apparent. On the other hand, the communicability of COVID-19, as well as the steps taken to reign it in, have created new obstacles and challenges for clinical sites.
Perhaps the biggest change to the healthcare industry caused by COVID-19 is the necessity of “social distancing.” In order to reduce the spread of the coronavirus, people everywhere are self-quarantining as much as possible. As beneficial as this is in fighting the ongoing pandemic, it nevertheless complicates the clinical trial process in a number of ways.
Notably, it makes it difficult for medical professionals to meet with, examine, and observe test subjects as often as they normally would. It’s worth noting that limiting exposure to the coronavirus is not solely due to concerns about the virus itself, but also how it can interact with and agitate a patient’s preexisting conditions. Slowed recruitment/enrollment is a common consequence of efforts to increase physical distancing, as are travel restrictions and resource delivery delays.
To circumvent some of these issues, it is recommended that those overseeing clinical trials consider when in-person meetings are and are not necessary. Greater emphasis should be placed on decentralization, mobile monitoring, and virtual communications when interacting with patients as well as with peers.
As implied above, the obstacles created by the COVID-19 pandemic have required those overseeing clinical trials to adapt their approaches. The newly heightened reliance on mobile monitoring and virtual communications is just one of the ways in which clinical trial protocols have been forced to change.
To wit, at the very moment when a physician, patient, or visitor first enters a clinical site, it is critical that they are screened for coronavirus infection. Maintaining clear lines of communication with site partners is similarly vital, as is the development of an infection control plan should the site be forced into lockdown. Even the basic navigation of the physical space must be reconsidered so as to accommodate physical distancing.
The very institution of these new and altered protocols poses a challenge all its own. That is, the time and resources required by them may detract from the trial. What’s more, the need for different and sometimes inconvenient protocols will likely slow down trials by increasing the complexity of coordination and the execution of even simple clinical tasks.
On the subject of resources—and that includes everything from equipment and manpower to time and data—the importance of shifting these things towards the proverbial front lines is all but inarguable. In light of the ongoing health crisis, combatting COVID-19 and treating those it has afflicted is the primary concern for virtually all medical professionals.
A side effect of this, however, is that the total sum of resources is stretched thin, sometimes to a point where clinical sites are unable to accommodate the burden. More and more sites are closing or are in danger of closing, and clinical trials that avoid outright suspension may find their capabilities diminished via scarcity.
Despite all this, site partners frequently demonstrate a clear desire to continue hosting trials, with efforts being made to advance testing and data collection despite these new challenges. With questions about how long the coronavirus pandemic will last and how permanently it might impact the healthcare industry still unanswered, it’s clear that complacency is simply not an option. Clinical sites and those overseeing clinical trials must be willing to work together to rebuild the process from the ground up.