New Era of Research Opens Doors to Patient Homes
Recent advances in connected medical devices are enabling a paradigm shift in clinical trials, allowing more research to be conducted directly in patients' homes rather than confined to study sites. This revolution is being driven largely by smaller, more convenient devices that can passively collect physiological data remotely and transmit it digitally with minimal patient burden.
With over 130 studies now leveraging wearable devices to enable decentralized trials, broad acceptance has been reached across the industry. Regulators are actively encouraging collaboration between pharma and device companies to expand development of innovative technologies. The goal is to increase trial access and diversity through the patient benefits of home-based research.
Optimizing Trial Design for the Home Setting
Key lessons have been learned recently about best practices for optimizing clinical trials in the home environment. Study protocols must choose digital endpoints and devices that precisely align with the trial objectives and regulatory requirements. Intuitive, easy to use technologies reduce the burden on patients and caregivers, facilitating higher quality data collection and protocol adherence.
Rigorous data management is essential, including extensive monitoring, automated cleaning and analysis tailored for the home setting. This ensures continuous, high quality data is generated to support accurate study conclusions.
Critical Steps for Operational Success
Choosing the right devices and tech-savvy vendors is a crucial first step. Key selection criteria include passive data collection, regulatory clearance, and a qualified vendor able to meet specialized home trial needs.
Careful logistics planning must accommodate country differences in regulations, documentation and infrastructure. Data privacy and security must be stringently safeguarded throughout.
Training and around the clock support enables patients to properly use devices and avoid data loss. Seamless data generation occurs through intuitive, user-friendly technologies. Automated data checks and time synchronization maintain pristine data integrity. Interim statistical reviews validate algorithms.
The Future is Brighter for Patient-Centric Research
By following these best practices, home-based clinical trials can yield higher quality, more continuous data leading to improved outcomes. The future is brighter for more patient-centric decentralized trials that reduce the site burden through connected devices.
Reference: IQVIA