In this interview, Komathi Stem shares how Sponsors can use health records in clinical research and clinical trial management.
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 Bionetworks, Komathi is flipping the traditional model upside down.
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:
[02:20] Why does monARC exists and what it does?
[02:40] Data generated through routine clinical care and how to aggregate it
[03:18] Patient powered registries
[05:04] Role of support groups, social media, clinician, and advocacy groups
[06:30] Mobile application to collect data between the clinical
[10:06] Understanding patient journey
[12:55] Geotargeting patients using Facebook
[23:55] Traditional versus “real-world” clinical trial
[28:00] Looking at the natural progression of the disease via a natural history study
- getting data on patients with no intervention
[30:00] Measuring treatment impact with a digital endpoint
[35:10] Impact of the intervention of Quality of Life (QoL)
[39:13] Challenges with real-world data
- Access to the data
- Different formats and need for standardization
[53:30] Speed of decision making in big pharma
[53:48] Creating a sense of urgency using storytelling
[56:45] Importance of developing trusted relationships
[1:00:10] Future of electronic data capture (EDC) with the rise of real-world projects
[1:00:15] The current state of EDC and EHR integration
[1:01:50] Accelerating Research through Collaboration
People, Resources, and Organizations Mentioned:
- CRF Part 11
- NASH Network
- Framework for FDA’s Real-World Evidence Program
- HL7 FHIR
- Individuals’ Right under HIPAA to Access their Health Information 45 CFR § 164.524
- 21st Century Cures Act
- Innovative Medicines Initiative (IMI)
- EHR4CR – Electronic Health Records for Clinical Research
- Kevin Kelly – The Inevitable
- TASTE randomize registry trial
- Komathi Stem
- Michael Doherty
- Hal Barron