SOAR^®: Expanding Patient Access And Driving Efficiency By Enabling Direct Data From Source To Submission

The process for developing and approving new therapies for patients has been under scrutiny for at least three decades; concern regarding a "broken" clinical research system has been voiced by many, including patients and caregivers. Despite global technological advances, the costs and efficiencies associated with bringing a new product to market are going in the wrong direction, (i.e., higher costs with longer cycle times). It is well-documented that research protocols are becoming more complex, the amount of data collected per study is increasing, and cycle times are getting longer (1). Many physicians conduct one study and no more due to excessive administrative burden. Prices for new drugs have skyrocketed.

What will it take to reverse this trend? The number of patients and physicians participating in clinical research must increase. New

technology must be applied in novel ways to radically change the research process. Standards for health care and clinical research need to be applied from the start and better harmonized, and other bridges must be built to more closely link research and health care.

To that end, the FDA and other regulatory agencies are encouraging the use of new technologies, electronic health records (EHRs) for research, eSource, real-world data, and decentralized trials (3). A recent FDA communication encourages innovation in lieu of the status quo.

This white paper first explores current issues with clinical research and the stimuli that are aligning to address them. It then describes the System of Accelerated Research (SOAR^®), a transformative model that adheres to all required regulations while accelerating the overall research process, ensuring quality and integrity and focusing on the patient.