CTP 024: Using Medical Records to Pre-Qualify for Clinical Trials with Komathi Stem

Using Medical Records to Pre-Qualify for Clinical Trials with Komathi Stem The traditional model involves sponsors and CROs contracting with trial sites and hoping the sites will find and enroll eligible patients.  Through her work at monARC Bio, Komathi Stem is flipping the traditional model upside down.  In this interview, Komathi shares how patients can now share medical records for clinical research purposes.  Pharmaceutical and medical device companies can then leverage this data to easily identify potential clinical research patients. With the rapid growth of software technology and high pressure to keep medical costs down, there is a growing need and application of real-world data in clinical research.  For this reason, we are likely to see a rapid use of technology and the use of real-world data in clinical research and trial management.  In this interview, we’ll cover the following topics: Why does monARC exists and what it does?  Data generated through routine clinical care and how to aggregate it Patient powered registries  Role of support groups, social media, clinician, and advocacy groups Mobile application to collect data between the clinical Understanding patient journey Geotargeting patients using Facebook Traditional versus “real-world” clinical trial Looking at the natural progression of the disease via a natural history study getting data on patients with no intervention Measuring treatment impact with a digital endpoint Impact of the intervention of Quality of Life (QoL) Challenges with real-world data  Access to the data Different formats and need for standardization Speed of decision making in big pharma Creating a sense of urgency using storytelling Importance of developing trusted relationships Future of electronic data capture (EDC) with the rise of real-world projects The current state of EDC and EHR integration Accelerating Research through Collaboration