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| EDITORIAL |
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| Year : 2018 | Volume
: 50
| Issue : 3 | Page : 105-107 |
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mHealth technologies in clinical trials: Opportunities and challenges
Ashish Kumar Kakkar, Phulen Sarma, Bikash Medhi
Department of Pharmacology, PGIMER, Chandigarh, India
| Date of Submission | 30-Jul-2018 |
| Date of Acceptance | 30-Jul-2018 |
| Date of Web Publication | 16-Aug-2018 |
Correspondence Address:
Bikash Medhi
Research Block B, 4th Floor, Room No. 4043, Chandigarh - 160 012
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/ijp.IJP_391_18
How to cite this article:
Kakkar AK, Sarma P, Medhi B. mHealth technologies in clinical trials: Opportunities and challenges. Indian J Pharmacol 2018;50:105-7 |
The exponential growth and advancement of mobile and wireless technologies and increasing network coverage and novel opportunities for integration in the existing health systems have fueled the rapid development of mobile health technologies for the promotion of quality health care. The scope of digital health, as per the US Food and Drug Administration, includes mobile health – mHealth, information technology, wearables, telehealth, telemedicine, and personalized medicine.[1] As defined by the World Health Organization Global Observatory for eHealth, mHealth – a component of eHealth – is a medical and public health practice assisted by mobile devices such as cellular phones including smartphones, monitoring devices, personal digital assistants, and other wireless technologies.[2] The practice of mHealth relies on device's core as well as advanced utilities and applications including voice communications, text messaging, third- and fourth-generation (3G and 4G) mobile broadband technologies, Bluetooth, and global positioning system (GPS) among others. The use of mobile devices has progressively become ubiquitous and increasingly indispensable in our day-to-day lives. Since 2014, mobile devices have outnumbered the world population, with the former multiplying at rates five times that of the latter.[3] Going by the projections, by 2021, there will be 1.5 mobile devices per capita, amounting to a total of 11.6 billion devices, and the average mobile connection speed globally will be >20 megabits/s.[4] Pew Research Center reports increasing rates of Internet usage and smartphone ownership in emerging and developing nations.[5] Between 2013 and 2015, the median smartphone ownership rates nearly doubled in emerging countries. The worldwide mobile health app market has been estimated to be valued at 28.32 billion USD in 2018 and is projected to reach a value in excess of 100 billion in the next 5 years.[6]
The current generation of smartphones incorporate several powerful sensors and components including camera, GPS, accelerometer, gyroscope, microphone, digital compass, and Internet access among others that allow data capture based on technical capabilities such as photo and video recording, location tracking, voice recording, measurement of physical activities, and assessment of sleep patterns besides data sharing and communications. The universal presence and acceptance of mobile phones, the ability and the habit to carry them everywhere, user attachments to phones – physical as well as emotional, and contextual awareness features make them especially suited to deliver health interventions.[7],[8],[9]
A World Health Organization survey seeking assessment of status of mHealth in member states found that 87% of the participating countries offered at least one mHealth programme to their populations, with 75% implementing four or more types of mHealth services. Furthermore, 80% of low-income countries reported implementing at least one mHealth service with increasing number of services being reported as “established” as compared to a previous survey.[10] The breadth of mHealth applications in the developing world can range from spreading awareness and education for remote data collection and monitoring, communications between individuals and health-care services, communicable disease and epidemic tracking, health monitoring and surveillance, diagnostics and treatment, and intersectoral communications.[10],[11]
The potential of mHealth technologies in revolutionizing clinical trials and enhancing participant and patient engagement is being increasingly recognized by sponsors, investigators, contract research organizations, as well as academics, and the field is undergoing rapid expansion. This is exemplified by the fact that the term “mHealth” was mentioned in 185 clinical studies posted at clinicaltrials.gov between 2013 and 2015. This number has since more than doubled to 371 for studies posted 2016 onward.[12] While the USA and Europe still account for nearly 65% of these registered studies, the share across developing countries is also expected to increase given the steady development of mHealth technologies in these areas as highlighted above. These tools including mobile devices as well as apps can support clinical trials in myriad number of ways.
They can aid in patient recruitment and retention, thus accelerating successful trial completion, providing more comprehensive data on drug safety and efficacy, as well as reducing overall study costs. For patients, mobile health technologies can provide access to studies specific to their health needs, enhance convenience by reducing study visits and through online surveys and assessments, aid in patient education and consent requirements, and facilitate retention and participant engagement through “gamification,” reminders, and online surveys. Wherever feasible, through dedicated apps, patient cohorts can network with each other, thus providing them social and emotional support. For trialists, these tools aid in 24 × 7 wireless tracking of real-time patient data allowing accrual of datasets that otherwise would not have been possible using conventional means. They can enhance and ensure participant compliance and can provide real-time feedback to improve the efficacy of interventions such as physical therapy. In addition, these technologies can alert the investigators about situations that require immediate interventions to ensure patient safety. Many of these applications can be employed using participants' own smartphones without the need for additional devices. A study examining clinical trial costs and barriers for drug development, conducted by Eastern Research Group under contract to the US Department of Health and Human Services, found wider use of mobile technologies as one of the most effective means of reducing trial costs across therapeutic areas and clinical trial phases.[13]
Several studies including systematic reviews and meta-analyses have evaluated the role of mHealth intervention strategies in the resource-constrained settings. Stephani et al. conducted a systematic review of randomized controlled trials (RCTs) evaluating the impact of mHealth strategies on noncommunicable diseases in low- and middle-income settings. Their study could not reach a definitive conclusion due to heterogeneity of interventions and outcome measures as well as small number of studies.[14] The role of mHealth technologies in supporting clinical trials per se, however, needs to be further evaluated. Anguera et al. evaluated the feasibility of a mobile RCT in depression patients where treatments were delivered and assessments were made wholly through mobile devices. They could recruit a large number of participants within a short span of time and with minimal study costs. However, study engagement was challenging and retention rates were suboptimal.[15] Similarly, Volkova et al. developed a food label trial smartphone app to conduct a fully automated RCT to assess the effects of nutrition labels on food purchases. The app included screening, informed consent, registration, and management of individual participants remotely without requiring any manual intervention from the study personnel. The preliminary app usage statistics were promising and nearly 1500 users could be enrolled to receive the trial intervention.[16]
In a global survey involving participants from clinical research organizations, service providers, consultants, academia as well as laboratories, the most significant benefits of mHealth in clinical trials were described as improved data quality, patient engagement and adherence, and early safety signal detection. More than half of the respondents were current users of mHealth technologies and nearly half planned to include it in their trial protocols within a year. Wireless health monitoring in specific disease conditions was recognized as the most effectively used technology, and the key therapeutic areas where mHealth was considered most useful were cardiovascular, respiratory, sleep disorders, oncology, mental health, and neurology.[17] A more recent survey of respondents based in North America, Europe, and Asia revealed that more than 35% of companies are employing mHealth technologies in their clinical trials and 94% plan to increase the utilization in the near future. Among the current users, the most commonly used technologies are the mobile apps, followed by monitoring devices, activity trackers, and drug delivery devices. For mHealth, the primary benefits appreciated were real-time data acquisition, improved patient compliance, and data quality.[18]
Although the application of mHealth technologies in the clinical trial space is poised to intensify in the near future, there are critical barriers and challenges that need to be overcome to ensure universal and effective implementation. Among the most significant challenges are the issues of data privacy and security, data validation and interpretation, difficulty in incorporation and adoption across trial settings, acceptability by patients and/or clinicians, regulatory acceptance, and increased patient as well as staff training burden. In developing world, the utility of mHealth technologies can be undermined by hardware complexities and limited technical literacy of trial participants. Another potential challenge for fully automated mHealth-enabled RCTs is maintenance of patient engagement in the study protocol, especially for longer trial periods. Hybrid approaches involving more direct contact between participants and study team using videoconferencing and other technologies can help in improving retention rates. Challenges unique to this arena include the need to update the apps whenever newer versions of operating systems are launched, which requires additional testing, validation, and submission to the app store before participants can download and use them. In addition, it is virtually impossible to test the app functionality across the wide range of devices and operating system versions available to the consumers. In the “bring your own device” model of clinical research which is believed to improve patient engagement and lower operational costs, the requirement for smartphones with active Internet connection may limit the participation of certain individuals, leading to sample selection bias. With regard to electronic informed consent, the institutional ethics committees need to deliberate the ability to verify the identity of participants providing the consent, procedures to answer patient queries, use of electronic signatures, as well as data security, privacy, and confidentiality besides the traditional considerations. Overcoming these challenges is essential to allow wide-scale adoption and full realization of mHealth technology benefits in the clinical trials' space.
In conclusion, the utilization of mHealth technologies to optimize clinical trials including smartphones as well as wearables is expected to escalate in the near future. By improving patient recruitment and satisfaction, abbreviating trial timelines, and increasing the scale, speed, and convenience of data capture, mHealth promises to have a transformational impact on health-care and clinical research in general and pharmaceutical R&D in particular.
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