Applied Clinical Trials
Companies that have piloted decentralized workflows are benefiting from technologies that support study operations in the disruption caused by COVID-19, but how will the rest survive the new norm?
The clinical trials industry has undergone a significant amount of disruption due to COVID-19. I recently conducted a survey on LinkedIn asking my network about how the virus has impacted their studies, and the top two affected areas were enrollment and study visit disruptions. They are now tasked with creating new policies and procedures to address both. It is clear that we have entered a new paradigm after COVID; companies that have piloted novel decentralized workflows are benefiting from new technologies that support study operations in this new environment. In my work, I have found that many sponsors are attempting to address the disruptions. Some are managing to succeed, while others are not. In this article, I will discuss what sponsors will have to do to survive in this new normal.
While politicians are currently discussing how to reopen the government, economists are predicting a massive economic rebound, and a potential COVID vaccine becoming available around Q1 2021, I believe that it will take a longer while to get back to where we were before COVID. The economic reality is that we likely will be facing an extended recession, as many businesses (especially smaller study sites and clinics that rely on patient volumes) will not make it out the other end due to financial strain caused by a significant reduction in cash flow. Moreover, the psychological impact that this new environment will have on people likely will worsen and lengthen the recovery from the recession-imagine how long it’s going to take for people to feel comfortable congregating at restaurants, events, or even showing up to study and doctor visits. All of that hurts the economy.
Corona has left many sponsors scrambling to find ways to decentralize their trials. I’m noticing that much of the bureaucracy and risk-averse mentality that has stifled study decentralization in the past now has vanished due to (1) the FDA’s guidance to operate studies during COVID (encouraging decentralization whenever possible), and (2) the attempt by teams to save their studies from unraveling and avoid a massive number of protocol deviations due to missed visits.
Most sponsors have provided guidance documents to sites in the wake of the pandemic to avoid immediate risks associated with study problems. Unfortunately, some sponsors have gone to an extreme by putting their studies on hold by halting the enrollment of new subjects. Other sponsors are attempting to salvage their studies by trying to find traditional yet immediate ways to address missed study visit risks, such as providing transportation reimbursement to subjects who are hesitant about utilizing public transportation, and encouraging sites to leverage technologies (some of which are not HIPAA compliant) to conduct virtual visits. A few sponsors have left their study sites to scramble without much guidance.
As we all enter into this new situation, we will have to adapt to running studies in a decentralized fashion. Sponsors that do this effectively will advance their research and continue to stay ahead of the competition. Those who do not will delay their studies and eventually succumb to the competition. Will this unprecedented phenomenon turn certain companies into dinosaurs? It will be interesting to see if H. G. Wells' adage, "Adapt or Perish", holds true in the near future.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.