Author: Mr. Vinu C Raju – Clinical Statistical Programmer at Genpro
Have you ever wondered how your social networking app is suggesting a friend request for a person you met yesterday in a get together? If so that is the power of machine learning. The same is been explored in the field of Clinical trials as well, wearables and app sensors are widely used in clinical trials to receive real-time data especially for the terminally ill patients’ data collection and for developing orphan drugs. Innovation teams of pharma companies are continuously working on new technologies that can bring trial data directly from patients to database and for real-time decision making.
Despite the impressive size of the clinical trial market, the industry faces several hurdles. The prime challenge with undertaking a clinical trial is cost. The industry has already seen how cancer, liver disease, and Alzheimer’s disease trials have had trouble finding patients for their studies. Advantage of going digital will be cost-effective Increase patient adherence, Improving Data Collection, reducing costs any time access to investigator site, Diversifying Patient Populations and easy analysis of the data.
Science 37 has already initiated many remote based site operated through telehealth system. But all these facilities need clarity on the guidelines and best practices. The industry should understand the need and suggest practical implementations on digital health systems and data handling from those systems.
FDA in parallel already working on the same and have released many regulations, docs and policies. It has announced its Digital Health Innovation Action Plan, digital health software Precertification Pilot Program, released guidelines [SaMD (Software as a Medical Device) applications, 21st Century Cures implementation, etc] and built bench strength and expertise in CDRH’s (Center for Devices and Radiological Health) digital health unit. Under the 21st Century Cures Act, certain medical software, including certain software that supports administrative functions, encourages a healthy lifestyle, serve as electronic patient records, assists in displaying or storing data, or provides limited clinical decision support, is no longer considered to be and regulated as a medical device. A classic example of FDA clearance on Apple Series 4 watch with ECG shows regulatory encouragement for digital health. Companies have to come up together and make programs with regulatory bodies and frame best practices.
The future is for real-time data and simulations as a cost for conventional data collection is skyrocketing and pharma companies are in pressure to reduce the operational cost of clinical trials. The innovation of AI enabled Biosensors and pooled data is the driving factor for future data collection and the game changer of next-generation clinical data capturing … Science and innovations never fail to excite you!!! Be ready for a sensor which can predict the possibility of your life span and of course “YOUR DEATH”.
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