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Going Paperless: How Digital Technology Can Shape the Field of N-of-1 Trials

Authors: Samuel Tan, Farhad Fatehi, Steve Donoghue and Sandy Bodner

Digital technologies and services have transformed the landscape of healthcare on a global scale. Electronic health records, telehealth systems, and artificial intelligence programs have now been implemented across hundreds of countries, and the application of digital technology in health shows no signs of slowing down. These developments have brought with them a plethora of novel solutions and challenges. In this blog, we’ll briefly evaluate how digital technology has shaped health research to date. Subsequently, we’ll explore the potential for digital tools to promote and expedite N-of-1 trials going forward.

Bringing Technology to Clinical Research

Recruitment for clinical research studies can often prove challenging. This is especially true for studies involving rare conditions: often, the low incidence of any rare disease in a given area makes the recruitment of a sufficient number of participants for a traditional group-based clinical trial practically infeasible. However, this is increasingly being mitigated through strategies such as tele-conferencing and Internet-based data inputs and more recently mobile-based frameworks for clinical research, which allow researchers to expand and conduct studies involving a larger number of participants without requiring face to face visits. Similarly, retrospective clinical studies have often relied on the infamous ‘chart review’: a paper-based system of data collection plagued by long lead times, significant logistical requirements, and often poor data quality. In contrast, the use of electronic medical records and network-connected medical devices allows for automated and precise data collection, and has been demonstrated to improve data quality and collection efficiency across both practical and academic healthcare contexts. Indeed, prospective data collection of patient data using databases such as the Rare Disease Registry and Analytics Platform offer the potential to streamline data collection and analysis, thus improving the feasibility, reach, and scope of clinical research for patients with rare conditions.

The Rise of Mobile Apps

Online platforms and smartphone applications (Apps) are increasingly gaining traction for the management of chronic conditions, including, for example, congestive heart failure, diabetes, and attention-deficit hyperactivity disorder. Such ‘mobile health’ apps can offer significant advantages to patients and their health providers, including providing relevant health information and education; promoting treatment engagement and continuity of care; and generating reminders to encourage adherence behaviours. They are also increasingly used for conducting clinical trials.

Notably, several mobile apps have been developed with an explicit focus on N-of-1 personalized medicine. For example, N1-Headache® is the first digital health platform to apply N-of-1 analytics to personalize management of migraine. N1-Headache connects people with migraine to their clinicians through a mobile app and web-based dashboard.  It requires users to log information about their headaches, migraine symptoms and medication use on days they have an attack, and also track a range of potentially disease-modifying lifestyle factors (moods, weather, diet, etc.) on a daily basis. After patients have recorded data for a minimum of 90 days, their results are processed using an N-of-1 Analytical Engine and the results delivered as a set of three personalized maps: Individual Trigger Map™, Individual Protector Map™ and No Association Map™. The maps are incorporated within a Personal Analytical Report that patients may print out as a PDF and share with their healthcare provider. N1-Headache uses established international headache guidelines to classify attacks, measure disability and monitor medication use. The web-based dashboard for clinicians provides access to all individual patient information and provides alerts about potential overuse of medication (Figure 1).

N-1 headache screenshots
Figure 1. Two screenshots of the N1 Headache app, demonstrating A) an individual trigger map and B) a risk chart for acute medication overuse.

The Future for Digital N-of-1 Studies

Overall, digital technologies have the potential to improve clinical practice and greatly expedite the process of health research, with particularly strong implications for trial recruitment and the collection of high-quality data. Telehealth systems and mobile apps may greatly improve the reach of N-of-1 studies, allowing patients in rural and remote areas to participate and study investigators to co-ordinate broader and more extensive trials and to aggregate data from these studies (i.e. Pooled N-of-1 studies). Similarly, electronic records and disease registries allow for automated and customized N-of-1 data collection, as well as the possibility of ready synthesis of personalized retrospective and prospective data.

About the authors

Samuel Tan is a medical student at The University of Queensland. Samuel is interested in the application of N-of-1 trials in Fibromyalgia and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

Farhad Fatehi is a Research Fellow in Digital Health at The University of Queensland. Farhad has a special interest in the development and evaluation of new models of care, especially for chronic diseases, using innovative digital technologies. Farhad is the ICN Digital Health Theme Co-ordinator.

Sandy Bodner is VP Communications of Curelator Inc. She has more than 20 years of experience working with FDA regulated medical devices and diagnostic tests.

Stephen Donoghue is VP Clinical Development of Curelator Inc. His experience leading global pharmaceutical projects includes previous positions as VP Clinical Research Europe and head of the European development function with Elan Corporation, as well as global project leader.

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