As outlays on drug development continue to soar, the use of technology in clinical research has grown in significance as a cost saving tool. The advent of mobile health (mHealth) potentially marks a paradigmatic shift in clinical research by streamlining processes, as well as enhancing the patient experience. Now, it’s no secret that the pharmaceutical industry is risk averse and moves forward at a snail’s pace. So the opportunities afforded to us as an industry by these innovative, novel technologies must be maximised because at this point in time, we haven’t fully capitalised on them.
Although, in 2015, 300 clinical trials listed on clinicaltrials.gov employed an mHealth solution, nearly double the number of trials in 2014, proving progress is being made. Furthermore, the role of the Internet as a mode of recruiting patients has grown in significance over the years. Studies show that e-Patients are 60 percent more likely than the general population to have participated in clinical research, demonstrating the Web’s ability to attract a new target population. Recently, the buzzword within pharma circles is ‘patient centricity’ and there has been a noticeable drive to create trials that prioritise the patient’s needs above all else. If we are to truly create patient centric trials, then the use of mHealth is critical.
Technology in Patient Centricity: Patient Engagement
When looking at ways industry as a whole can create patient centric trials, it’s important to note that the success and failure of a trial invariably depends on a site’s capacity to recruit patients. According to a 2012 study by the Tufts Center for the Study of Drug Development, Phase II-IV study timelines, in reality, nearly double target timelines. For that reason, it’s important to gain insights into how studies are run from the patient’s perspective. By running focus groups and using surveys, you can not only explore and refine assumptions about the patient experience, you can test and verify them.
Furthermore, while we all know recruiting patients can make or break a clinical trial, simply recruiting them is only half the battle. Retaining the patient is equally as challenging. High drop-out rates and low drug compliance can be difficult to guard against as the onus on patients to manage their clinical schedule can be burdensome. Therefore, ensuring that you engage with the patient throughout the process is vital to the success of a trial. Nowadays, there are numerous patient engagement apps that offer a unique way of helping patients manage their participation by placing the entire contents of a typical patient kit onto a mobile or tablet device.
By encouraging patients to use these apps, you can potentially improve retention rates by simplifying interactions and increasing compliance. There is great potential in the use of patient engagement apps. They can, on the one hand, reduce protocol violations while limiting out of window site visits on the other. They can also increase drug administration compliance due to improved procedural and schedule awareness, as well as enable alternative ways of gathering higher volumes of quality data.
The rise of patient engagement apps in the last few years has been noticeable and its impact thus far cannot be discounted. Make no mistake, they are here to stay.
Making the most out of mHealth tech
To place things in perspective, the top 12 pharma companies have established approximately over 250 unique medical reference and condition management apps. With 6.6 million downloads and 300 clinical trials implementing mHealth, there is real promise for it to transform trial participation and health outcomes by:
- Increasing education and awareness
- Enabling diagnostic treatment and support
- Reducing the paper burden on study sites, PIs and patients
- Enabling the use of electronic forms
- Enabling decentralized trials
- Enabling remote monitoring
- Enabling remote data collection
- Improving early safety signal detections
- Improving communications between drug maker, CROs, sites and patients
- Reducing geographic barriers to participation
- Improving Adverse Event Reporting.
The continual advancements made in mobile technology and its accessibility is transforming clinical drug development. The use of mobile apps in clinical trials, in particular, is expanding rapidly beyond those focused on patient recruitment, retention, and adherence. While the technology on hand offers many solutions to persistent industry challenges, higher data quality, systems compatibility, and data integration will continue to present big challenges for our industry. Although significant strides have been made over the last few years, we are yet to reach mHealth’s watershed moment.
*This article was based on a presentation given by Bardia Akbari, Global Head Clinical Operations, Oncology, Genentech, delivered at Arena International’s 2016 CTO West conference.
 Source: ClinicalTrials.gov (June 2015); IMS (August 2015)
 Engaging e-patients in Clinical Trials through Social Media, Blue Chip Patient Recruitment, 2011
 Source: Tufts Center for the Study of Drug Development 2012.
 Nielson 2015RockHealth 2015ClinicalTrials.gov (June 2015); IMS (August 2015)