By Vicki Anastasi and Matthew McCarty, ICON Plc
Digital health technology can improve reporting of patient data during clinical trials, but it can also lead patients to drop out.
Digital health technologies are changing the way companies design and implement clinical trials, shifting responsibility from investigator to patient. Adding multiple digital health technologies into trial design, including mobile health (mHealth), health information technology, wearable devices, telehealth, and patient-reported outcome measures (PROs), can increase the burden on the patient.
This extra burden can reduce patient compliance and retention. Studies have shown that more than 30% of patients drop out of clinical trials before their results can be evaluated, and that about 85% percent of clinical trials fail to reach completion due to problems with patient retention. Companies must adopt a unified patient experience.
What is a unified patient experience?
A trial with a unified patient experience enables patients to manage every aspect of the trial via a single, one-touch access point. This could be an integrated smartphone app that includes features under one login, such as ePRO, sensor connection, notifications, gamification, reimbursement, travel management, study information, and profile management. Giving patients the choice between a digital touch and personal contact (e.g. a patient contact hub) may further increase patient engagement in a clinical trial by:
Using the right channel for the right use
Providing patients with choices to suit their preferences and circumstances
Marrying the convenience and efficiency of digital technology with the trust and depth of personal contact
A unified patient experience can improve patient engagement
For example, many mHealth wearables acquire data remotely and passively with little to no effort on the part of the patient. When patients must manually enter data, they can do so on the app’s digital diary or by calling the patient contact hub at their convenience, rather than visiting the trial site. Reducing the number of site visits cuts travel costs and time. When patients do need to travel to the study site, they can use the same patient app or contact hub to organize travel plans—from a full concierge service to booking local taxis—removing the burden of planning or paying for travel.
Integrating a unified patient experience can enhance patient retention
Having a unified patient experience can also improve retention by resolving problems that could cause patient dropout or lack of usable trial data. When a patient’s digital health device indicates noncompliance such as patient failure to record a blood pressure reading, the patient contact hub can immediately ask whether the patient needs help or whether the mHealth device needs repair. A quick response to these issues can keep a trial running smoothly and improve the quality of data collected while retaining patients.
By successfully integrating digital health into clinical trials via a unified patient experience (offering a single digital and personal contact solution) sponsors and device developers can optimize data collection, improve patient retention and engagement, and ultimately avoid costly delays or failure.
Vicki Anastasi is vice president and global head of medical device and diagnostics research for ICON plc. Matthew McCarty is senior director and global head of patient engagement for ICON’s commercialization and outcomes division.