Last week Novartis and Science 37 announced an expanded alliance through which the companies will launch up to 10 “decentralized” clinical trials across the US.
Decentralized trials shift some or all aspects of a clinical trial from a central site, such as a hospital, to the participant’s home or physician’s office.
“By bringing the trial to the patient, Novartis aims to decrease the burden of clinical trial participation on patients and trial centers,” Jake LaPorte, global head of digital development at Novartis told Outsourcing-Pharma.com.
The more flexible approach also could benefit underrepresented populations.
LaPorte said: “This approach also has the potential to increase the reach of our leading drug development and clinical trials enterprise into under-represented and underserved populations around the world, improving the caliber and quantity of data available to aid in drug discovery and development.”
Currently, Novartis is in the process of selecting specific indication and trials where it will deploy the decentralized approach, which leverages Science 37’s technology to enable patient participation using mobile devices and telemedicine services.
LaPorte said the characteristics of the target patient population, including size, will be defined after these decisions have been made.
The studies will use both decentralized and traditional models, “with the aspiration of attaining increasing degrees of decentralization towards a mostly ‘site-less’ model overtime,” he added.
“Our aspiration, overtime, is to recruit a significant portion of patients into this decentralized model when deployed on a clinical trial.”