The broader impact/commercial potential of this I-Corps project would be to enable substantial improvements in clinical trial efficiency. Current industry wide average cost to bring a novel medicine through FDA approval has now exceeded $2.6 Billion. The average time for the same is 10 - 15 years. Typically, industrial customer spends an average of 16,000 to 26,000 US dollars per patient recruited into a phase I, II or III trial, with phase III recruitment costing the highest. With this project's innovative model assisting virtual clinical trials, the cost of recruitment alone can potentially come down significantly as the costs associated with multiple sites setup and monitoring would be eliminated. Each customer will also likely to see significantly reduced dropout during the trials, thereby reducing overall cost and compressing the schedule of the trial.
This I-Corps project develops a virtual siteless environment for clinical trials. This environment will reduce risks, accelerate trial recruitment using e-consent, aid in conducting multiple virtual follow-up sessions with trial participants without requiring their travel to trial sites. It will also enable collection of data continuously, through participants' wearable devices, web-deployable questionnaires and surveys, home based specimen collection kits or through home visits by a nurse or phlebotomists. This integrated environment for virtual clinical trials will potentially integrate a patient facing application for text, image, video and voice interactions, data hub for integration of clinical, molecular, and digital biomarkers as well as capture of health information.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.