The New Dinosaur: Sponsors Who Do Not Decentralize Their Studies

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.

The reality of COVID: disruptions will last a while

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.

How the industry is responding

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.

What’s not working

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.

What is working

  • Clear COVID guidance to sites-Successful sponsors have issued guidance documents to study sites on how to manage their study while navigating through the pandemic. This guidance typically consists of direction from the IRB, FDA material and information, and study-specific supervision. These include administering the investigational product, offering protocol amendments, safety reporting, advice as to which protocol deviations should be documented, and management of how to document these deviations.

  • Protocol trimming-Some sponsors are amending their protocols and data collection systems to eliminate data that does not contribute to the study’s primary endpoints. Many of these amendments also include reducing unnecessary study visits.

  • Study procedure redesign-Many sponsors are allowing study sites to conduct visits remotely. These include video visits (i.e., to perform rater scales, and AE reporting). Others are providing sites with reimbursement to send research coordinators to the patient’s home to conduct vitals and collect bloodwork to be transported and processed back at the site. 

  • Remote monitoring-Many sponsors are now seeking and implementing remote monitoring solutions through the use of technology. Many remote monitoring solutions providers have posted news on the Applied Clinical Trials website. 

  • Strategy: moving site management away from monitors to in-house project management-Since monitoring visits are happening remotely, study site engagement is essential. Due to the enormous number of emails we are receiving (and sending), and due to the urgent nature of these issues, we have set up electronic chat groups with our sites to allow them to interact directly with project management. This setup enables us to not only capture issues before they manifest into more significant problems, but also to document these matters in an issues resolution tracker and respond immediately to the site.

Decentralize or perish

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.