Patient recruitment and retention has always been a major cause of delay and expense in pharmaceutical clinical trials. Almost 80 percent of clinical trials fail to meet their enrollment timelines, and nearly 50 percent of trial sites enroll only one or zero patients.1 Patient recruitment activities represent more than 25 percent of overall trial costs — according to a study by the U.S. Department of Health and Human Services (HHS), an average of $805,785 is spent on recruitment from Phase 1 through Phase 4.2
An effective patient retention and engagement program is critical to controlling dropout rates, and hence reducing costs, lowering duration, and increasing the likelihood of success in clinical trials. Thus, pharmaceutical companies are moving towards a patient-centric approach to retention and engagement, with technology as a key enabler. For technology to be effective, it must deliver the necessary features and fit seamlessly into the patient’s daily routine. However, the right technology not only improves active trial participation, it also improves the quality and accessibility of data collection during clinical research.
In this article, we will assess the mobile health apps market, key features of successful apps, and associated timelines and costs for developing apps that engage patients across categories and conditions.
Technology Enhances Communication & Reduces Costs
The patient-centricity movement in clinical trials recognizes that if patients are supported throughout a study, higher levels of compliance and retention can be achieved. Continuous engagement with patients throughout their clinical trial experience, and simplifying methods of data capture and reporting are now seen as vital to pharmaceutical R&D success.3,4
The rise of electronic clinical outcome assessments (eCOAs), and specifically electronic patient reported outcome (ePRO) tools implemented through everyday mobile technology, has transformed how patients can be engaged throughout a clinical trial.5 Using these tools, pharmaceutical companies can now design studies to include relevant, standardized, and tailored communication plans, delivered through text messaging, email, and/or in-app notifications.6 As such, patients can be prompted to take medication, record health data, and attend site visits. Plus, sites can follow up with patients if data isn’t being entered in the correct manner, rather than waiting for their next site visit.
BYOD (bring your own device) trials, especially in the early development stage, offers true scalability for eCOA and has the potential to greatly reduce the cost and logistical complications of providing and maintaining traditional ePRO devices for trial participants. However, provisioning may be required when, for example, a validated instrument is used to assess primary outcomes, or when Bluetooth integration with next-generation home monitoring devices is involved. Selection of simple BYO smartphone or tablet devices can provide cost-effective solutions, while maintaining the benefits of mobile ePRO.6
An easy and engaging method for data capture can reduce data gaps. This along with an effective ePRO solution can increase quality and reduce the need to pad sample sizes. Padding is done in an effort to minimize the impact of missing data and discontinuations - an extra 10 percent is added to offset anticipated losses. Additionally, in larger event driven outcomes trials, retention of patients increases the number of observe events, bringing the study to an earlier close; reducing overall cost and duration.7
An Overview Of The Mobile Health App & Device Market
Mobile technology is increasingly being implemented in clinical trials due to their real-time data collection feature. Additionally, they provide means of communicating directly with patients across broad demographics and multiple locations.3 Sponsors and CROs are actively searching for opportunities to incorporate mobile solutions into trials to increase the probability success.
The mHealth market is made up of connected medical devices and healthcare apps, with the former generating 80 percent of revenues between 2013 and 2016. While medical devices have been around for decades, the advent of smartphones with Bluetooth technologies and internet connectivity has resulted in a rapidly growing number of apps designed for a multitude of healthcare-related purposes, from monitoring body temperature to measuring heart rate.8
According to Allied Market Research, the mobile health industry is growing at a staggering rate of 25 percent per year and is expected to reach an estimated $58.8 billion by 2020 (Figure 1).The key drivers of this trend are apps and devices for cardiac monitoring, diabetes management, multi-parameter tracking, etc.
The mobile app market is highly fragmented, with a large number of developers spread across the globe. Europe and the Asia Pacific (APAC) region hold the greatest market share, each at 30 percent, followed closely by North America at 28 percent (Figure 2a). Within the APAC region, China and Japan leading in market share with 37 percent and 21 percent respectively. Figure 2b shows the top 10 countries by mHealth revenue.
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