Clinical trials are being conducted at exceedingly high rates to develop a safe and effective treatment to combat COVID-19, but the main issue is the drawn-out process it takes for clinical data to develop into usable treatments.
While many medical experts are hopeful for an effective vaccine by the end of 2020, realistic estimates predict that we will have a vaccine with enough doses to effectively treat the public by the end of 2021. Producing a vaccine in this time-frame is extremely fast given the usual procedure.
Typical vaccines take years to develop moving from the exploratory stage, to pre-clinical stage, then clinical development, regulatory review, manufacturing, and quality control. This process is currently being expedited given the gravity of the global pandemic, but with lives on the line, many are asking if there are other methods to create a treatment right now as opposed to waiting for a vaccine.
This brings to light the use and analysis of Real World Data (RWD) in comparison to Clinical data. Instead of being sourced from a lab or study the way that Clinal data works, Real World Data refers to observational data derived from practicing physicians, electronic health records, patient-reported outcome measures, insurance claims, medical devices, and mobile devices.
Dr. Victor R. Hrehorovich, a Infectious Disease Specialist and an epidemiologist who has worked for the CDC’s Epidemic Intelligence Service, explained that “In normal circumstances, the scientific community would commence Randomized Clinical Trials to determine what treatments are the most effective. The problem is that we find ourselves in the midst of a global pandemic and, under these circumstances, we do not have the time and luxury of operating as we normally would.”
In response to his own growing concerns, and to serve a critical need, Dr. Hrehorovich joined CrowdProtocol.com, a platform established during the ongoing COVID-19 pandemic to enable the discovery of an effective treatment via methodology and protocol utilizing Real World Data.
Much like crowdsourcing and crowdfunding, Crowdprotocol.com is designed to pull data quickly from a public and willing network of practicing doctors and scientists. The participants add their real time data to an online register that aggregates the information and allows that information to be shared immediately. In layman’s terms. if there is a treatment that is working well for a large percentage of patients, as demonstrated by the data entered, that treatment might be more readily considered and prescribed by other physicians. If the statistics are genuine, the results may indicate a quicker and safe treatment for whatever it is that the crowdprotocol pooled the data.
The appeal to use Real World Data comes from the life and death urgency that is facing individuals across the globe who lay fighting for their lives on medical beds. To reduce the amount of people put in that situation, many are opting to develop treatments given the drugs and tools at our disposal instead of working on a vaccine that takes years to develop.
Mid July reports show over 13.4 million confirmed cases of COVID-19 worldwide. 3.48 million of which are in the U.S. which is leading the world in confirmed cases.
“Based on the experience with influenza vaccines, I believe it will take time to have a vaccine that works and creates proven lasting immunity. There are, however, groups of patients who have received, and continue to receive, drugs, with long histories of safe use, in appropriate and FDA approved doses. Such drugs were tried because they offered a theoretic promise of antiviral activity, modification of the deleterious immune response (cytokine storm) or suppression of diffuse blood clotting, among other reasons,” Dr. Hrehorovich said.
CrowdProtocol seeks to gather, analyze and publish such RWD in the belief that, at this time, the best chance to defeat COVID-19 is to attack it with therapeutic protocols both prophylactically and early in its disease progression” said Dr. Hrehorovich.
Collecting Real World Data and using it to develop treatment protocols for various diseases serves as a practical and worthy method of gathering therapeutic information that may curtail current and future epidemics.