Novartis AG (NYSE: NVS; SIX: NOVN) has recently launched a new app, “FocalView”, aiming to provide “an opportunity for patients to participate in ophthalmology clinical trials from home”. According to the company, the new initiative is the “first-of-its-kind app” to make ophthalmic clinical trials more accessible and flexible. The app will capture patients’ self-recorded measurements for use as endpoints, facilitating the collection of more patient-reported outcomes. The initiative is equally beneficial to Novartis, given the considerable time and cost of conducting clinical trials, most especially the investment required to recruit and monitor both patients and trial sites.
FocalView is an “ophthalmic digital research platform” where researchers can track disease progression through the collection of real-time self-reported data from adults recruited and consented to a trial. The idea behind the initiative is to develop a more patient-centred and decentralized trial design, better suited to collecting data and reducing the traditional infrastructural costs of trials. The set-up and design of traditional site-based trials, generally organized around clinician-led recruitment and contract site organization monitoring visits, has under-gone considerable development over recent years. Trial co-ordinators continuously seek new ways to leverage an increase in trial participation and the streamlining of data collection. While the process will not be suitable for all clinical trials, many of the large pharma companies are actively researching opportunities to reduce the cost and time of drug development. One less month in trials may provide considerable commercial gains by getting drugs to market prior to a competitor. Increased use of virtual technologies is one very active tool designed to reach this objective.
Before expanding its use, Novartis has stated that FocalView will be tested in a prospective, non-interventional study, designed to evaluate the efficacy and usability of the app in assessing visual function – visual acuity and contrast sensitivity will be among the measurements captured. Simultaneously, researchers will study the app’s ease of use, the level of patient enrolment and how the critical component of informed consent can be managed appropriately. Insuring patient safety and data integrity will remain as gold standards and central obligations, regardless of the tools used to achieve them. According to Bertrand Bodson, Novartis’ Chief Digital Officer, “[o]ptimizing digital technology in research and development, particularly in ophthalmic disease, could have a marked impact on the quality of the data we capture. We believe apps like FocalView, which we’ve made freely available to the research community on an open-source platform, can help accelerate the development of treatments and bring them to the patients who need them most.” Such apps of course should be made freely available as the clear benefits for the company include a potentially reduced time and reduced financial investment in clinical trials, coupled with the potential to reach market faster, thereby securing both market space and increased profit.