Randomized Clinical Trials
Is Real-Time Data the Key to Accelerating Drug Development?
The development and production of new vaccines and medicines is a time-consuming process. In the face of the Covid-19 pandemic, how can we utilize modern digital technologies to accelerate the development of new therapies and enable the earliest possible access to promising, potentially lifesaving, new treatments?
In order to accelerate therapy development, the process of randomized clinical trials (RCTs) in drug development needs to be re-evaluated, as current practices are too slow for acute states of emergency like the Covid-19 crisis. We can accelerate the analysis of the efficacy and safety of specific drugs that have demonstrative potential by looking in real-time at real world evidence/data (RWE/D).
Digital Technologies Enable and Simplify RWE Studies
Accelerated studies should happen under the umbrella of a simplified, pragmatic RWE study. Patient data should be collected, continuously monitored and analyzed, almost in real-time, from electronic health records and electronic medical records (EHR/EMR). Digital technology has evolved to the point where, in a global health crisis like this, it allows us to react quickly, efficiently and for a large number of patients. Today, there are platforms and technologies available that can provide real-time insights into data across provider networks, combining real-time access to longitudinal clinical data with analytics and advanced visualization capabilities.
Digital Technologies Allow Patients to Report Symptoms Remotely
Another technology option in a health crisis is electronic patient reported outcomes (ePRO). In the case of Covid-19, it is deemed that the majority of afflicted individuals exhibit mild symptoms and may be under self-quarantine. While they may be unable to visit clinics and record clinical data for obvious reasons, they can easily use mobile apps for reporting clinical outcomes, such as simple measurements like the severity of cough and fluctuations in temperature. Remote monitoring can easily be orchestrated to support these efforts through this real-time data collection. This provides vital data streams for clinical analysis and avoids the protracted rigmarole of setting up new investigator sites and traditional means of patient recruitment.
Digital Technologies to Enable an Integrated Data Hub
Recent advances in digital engineering allow for mobile apps to be deployed and updated within days, thereby even rendering the RWE study “adaptive” in addition to real-time. It is possible to set up “visual command centers” for pandemics. For example, data streams from EMR systems and electronic clinical outcome assessment (eCOA) apps could come together from across the country to provide a daily/weekly snapshot of how the infected patient population is reacting to potential treatment for Covid-19. The whole system could be set up as an integrated research platform using umbrella designs where new treatments are seamlessly added, while ineffective ones are removed, determining safety and effectiveness in real-time and moving closer to successful treatments.
New Regulatory Framework Necessary
Regulations for drug development have evolved over the latter part of the earlier century and may be apt for treatments such as psoriasis, hyperlipidaemia — in essence, diseases whose progressions are incomparable to that of a pandemic. In a globalized world, we need to have a regulatory framework that enables the industry to switch to operating in an emergency mode with accelerated decision-making, drug testing and development in the wake of pandemics situations. We need to act at the speed of viral replication. In order to protect humanity from future pandemics, we need to have a new regulatory framework that allows us to develop, study, and test new promising compounds in a matter of weeks rather than in months or years.
Author: Srinivas Shankar, Global Head, Life Sciences, Cognizant, New York, USA