Lessons learned from the 2014 Ebola outbreak and how they can be transferred to the COVID-19 pandemic

During a pandemic, data collection is of the upmost importance to be able to control and stop the spread of disease. It is essential to have adaptable, available data systems with clear, simplified forms that can be completed off-line and these systems must be operable both on and off network to enable field workers to complete the fields while working in remote locations and then later upload the data to a repository when there is network access. Overall, a solid IT system is necessary for quick capture and relay of information.

Another challenge during an outbreak response is creating and disseminating effective and timely information to the public. This requires a full understanding of the knowledge, attitudes and beliefs of the target audience. Target communication needs to account for the local level of understanding and literacy while being culturally appropriate. There needs to also be a way of monitoring if the communication is effective, again this needs to be done in real time. It is vital that communication is simple, consistent and reliable.

The current COVID-19 pandemic has seen a large increase of data systems and other forms of communication. Furthermore, there are a huge number of clinical studies ongoing or in the pipeline to address this crisis. Moving forward, a central repository housing essential information (e.g. trial protocols and analysis plans, interim findings, and real-time reporting of primary results) on completed and ongoing clinical trials will be needed, in order to encourage collaboration and information sharing, as well as to avoid any redundancy in research efforts.

During the 2014 Ebola outbreak, my team and I attempted to create a data searching program to attempt to link cases with contacts, but it often did not match enough cases. This created a major challenge in tracking and monitoring the disease, particularly in attempting to understand how new cases were occurring, i.e. contacts from prior cases or some new cluster of infections. Data were often not linked due to lack of a unique ID assigned to persons with confirmed or suspected Ebola infection. Clinical and laboratory data were linkable after linking IDs; however, linking each case with their contacts and tracing contacts back to the original case was difficult.

In terms of using this methodology to follow and predict the spread of COVID-19, it is important to note that real-time data sharing of not only case counts and mortality figures but of also patient-level characteristics and demographics is needed. COVID-19 is affecting a widely heterogeneous population and outcomes are variable. To better understand the epidemiology of this disease, more information on patient classification and comorbidity are required.

There are, of course, several challenges that present themselves during a pandemic in terms of designing and setting up of trials. There can often be a rush in the using of experimental or off-label treatments, for example, in the absence of any safety or efficacy evidence from a randomized clinical trial. We see this happening now in that single arm studies and/or case series data are made public, causing rise to the use of products prior to any demonstrable safety or efficacy results from a well-controlled randomized clinical trials, despite the fact that we know this is the only design that can lead to conclusions of safety and efficacy. To make this process more effective, the focus should be on the promotion of well-designed, large, global, randomized clinical trials with clear and specific endpoints.

PHASTAR’s global team of technical experts are expediting clinical trials focusing on COVID-19. We continue to be available to discuss modifications of trials in light of the current situation and can help with any aspect of your trial from rapid database development, efficient clinical trial design/ review and communicating with regulatory agencies. We understand that every trial will have its own individual challenges arising from this pandemic and our team are on hand to discuss any of your concerns.