According to the Pew Research Center, 97% of Americans own some kind of communication technology such as a cellphone. Of those, 85% own a smartphone. Even among adults 65 and older, people with a high school education or less, and who make less than $30,000 per year, smartphone ownership is still common, with 61%, 75%, and 83% of adults, respectively, reporting ownership.
As the shift towards a decentralized clinical trial (DCT) model continues, sponsors and investigators can encourage potential participants to enroll in clinical research studies with the simple tap of a screen.
For researchers conducting clinical trials, these numbers are good news: they mean that the general public is more familiar with mobile medical apps, more experienced with communicating through their devices, and more likely to always have one or more of those devices on hand for access. As the shift towards a DCT model continues, sponsors and investigators can encourage potential participants to enroll in clinical trials with the simple tap on a screen.
Benefits of Mobile Apps
Across the industry, physicians, researchers, and sponsors alike are realizing the benefits that mobile health (mHealth) applications bring to the standard healthcare system and the modern clinical research enterprise (eg, DCTs). In the physician’s office, mHealth apps can assist in improving health outcomes. These mHealth apps are customized to fit the specific needs of modern clinical trials such as DCTs and they must be developed, verified, validated, justified and tested for usability at the hands of the end users prior to deployment in any trial. These mHealth apps must also operate in compliance with regulations and must produce auditability trails (ensuring quality control and quality assurance processes to maintain clinical data quality and integrity) for regulatory inspections and sponsor’s audits.
One study found that mHealth interventions in cancer survivors have “significant potential,” with further research to come. In clinical trials, these new technologies represent new and exciting opportunities for clinical data collection. According to an article published in Clinical Cancer Informatics, the pace of cancer clinical trials has not kept up with the exponential growth and discovery in the fields of immunotherapy and genomics. Developing new cancer therapies is both expensive and time-consuming—using mHealth apps and other emerging smartphone technologies to collect health outcome data may help researchers and sponsors justify the why behind a new clinical therapy.
One of the most obvious benefits of using mobile apps in clinical trials is patient access, enrollment, and retention. Patients who live in rural, underserved, or otherwise inaccessible areas likely have smartphones. In fact, mHealth evolved as a tool for developing nations precisely because of the rapid growth of mobile phone access in low-income countries. Within the US, 15% of adults are smartphone-only internet users—that is, adults who own a smartphone and don’t have access to traditional broadband internet service. These individuals tend to have a lower income, making less than $30,000 per year, have only some high school education, and live in rural communities. In the past, people in these socioeconomic and demographic brackets were often excluded from clinical research. Today, mobile health and smartphone technologies mean that access is more available to them than ever before, breaking geographic barriers, bridging the digital health division, and enhancing diversity and inclusion in DCTs.
Data published in 2019 show that 85% of all clinical trials fail to recruit enough patients, while 80% of trials are delayed due to either recruitment issues or participant dropout. The reasons for these participation issues are many and varied and can include a lack of awareness, limited medical literacy, geographic and socioeconomic barriers, unconscious bias, and travel requirements. DCTs address these issues head-on.
Recruitment and Retention
Recruitment and retention efforts are paramount to success in all clinical trials. The average trial dropout rate is 30%, which means that even trials that get off the ground may fail to collect the necessary data.
Up to 70% of potential participants live more than two hours from a clinical trial study site. For these individuals, trial participation isn’t an attractive prospect—especially in trials for rare diseases or cancer, where the burden of travel is high. A study published in 2018 showed that a DCT model where travel isn’t necessary is both “operationally feasible” and generally accepted by patients—leading to quicker recruitment and improved patient access.
When recruiting for a DCT, many of the standard recruitment practices may not necessarily change completely. For example, sponsors can still reach patients through physicians’ offices, social media, and other forms of advertising that have worked in the past. However, these opportunities are enhanced and diversified and they should emphasize the decentralized, digital nature of the trial—and that travel will not be required.
For sponsors who don’t want to reinvent the wheel, mobile apps and digital health tools may be incorporated into recruitment practices themselves. A variety of new clinical trial apps are available to help patients match with trials that meet their unique needs with a simple swipe of their finger. These apps are sometimes specific to research organizations—like the Cleveland Clinic’s oncology clinical trial app—or more general, open-source platforms that aim to transform participant engagement with the clinical research process.
In addition to specific applications, sponsors and research teams have begun exploring the use of mobile advertising to recruit trial participants, following multipronged approaches in DCTs. Given the high number of smartphone owners both globally and in the US, it makes sense to utilize an avenue for advertising that most people can regularly access. Advertising professionals have long debated whether mobile advertising works as well as traditional desktop or laptop online advertising, but data shows that studies see two to three times higher engagement and participation with mobile ads. For trial sponsors, then, mobile ads are often cheaper and more effective.
Overcoming Mobile Health App Challenges
As with any new opportunity, sponsors should examine challenges before proceeding full speed ahead with mobile app-based clinical trials.
While it may seem overwhelming to add data privacy and security to the clinical trial to-do list, sponsors and investigators have the obligation of creating an environment of trust and transparency where patient health information is protected. Data must be secured from hackers, malware, and other external threats, and sponsors should be clear with participants about what data is being collected, why it’s being collected, and how it’s being used. The use of application program interfaces, or APIs, is common, but they make mobile apps more vulnerable to hacking and electronic health record access—meaning that where possible, extra security is key.
Investing in technical support personnel is one way to overcome data security challenges within clinical research. Utilizing a big data security lifecycle model to guide storage, security, and access is another. Technologies like authentication, encryption, and data masking are widely available and relatively easy to employ with the right investment and may quell any fears that participants might have about using mobile technologies for health research. The use of encrypted digital communication systems is paramount and commonly used to ensure data privacy and to protect the confidentiality of participants in DCTs and other modern clinical studies. De-identification is another traditional method used to preserve privacy.
While trials that operate on a “bring your own device” (BYOD) model can save money by not providing devices like smartphones or tablets, troubleshooting technical difficulties can be a challenge. The Clinical Trials Transformation Initiative (CTTI) suggests that a thorough training process for both staff and patients can alleviate issues—but this training must “[go] beyond feature and function to incorporate the ‘whys’” for both patients and staff. In addition, the use of BYOD in modern trials such as DCTs may increase data variability of these devices are not calibrated and commissioned appropriately and according to the specific needs of a DCT, something that is routinely done to mitigate these sources of variability.
According to Premiere Research, more than 150,000 mHealth apps are available for smartphone and tablet devices. However, the proportion of clinical trial-specific apps is much smaller, most of which are search-based or provide information only.
Organizations like Apple have created tools such as ResearchKit and CareKit, two open-source code tools available to researchers and sponsors to develop apps. Sponsors and researchers can use these tools to contribute to the growth of the still-small number of trial-specific apps.
Sponsors also need to ensure app functionality across operating systems. It can be difficult to continually test apps across devices and ensure compatibility as device operating systems update, a particular concern as clinical trials tend to take place over extended periods of time. If apps are incompatible, data integrity, portability and interoperability might be compromised—which will negatively affect long-term trial outcomes. Investing in a team focused only on the technical aspects of app deployment and use can strengthen the role that apps play in clinical research, reduce potential participant drop-out rates due to frustration with the platform, encourage sponsors to incorporate these types of technologies in the future, and enhance overall participants’ experience in the clinical trials such as DCTs.
By taking the time to create a native companion app, sponsors can position themselves to create an environment where patients have all of the necessary trial information right at their fingertips. In addition to controlling the app environment, sponsors can provide relevant educational materials for participants, increasing health literacy and, perhaps, participant retention in the long term. Companion apps can help more patients adhere to medication regimens and ensure that patients are at the center of their own treatment plan.
Ultimately, mobile apps are among the most “promising and active efforts” in the mHealth sphere and represent an exciting new avenue for clinical research. mHealth apps can be a boon for clinical trial sponsors and researchers through thoughtful and strategic applications. These apps are powering clinical trials of the future, and sponsors that embrace these changes can reach more patients and, ultimately, gather better, more accurate data.
Improved participant access to clinical trials also increases patient diversity. The ability to connect to a broader population also increases the accuracy of evaluating the safety and efficacy of novel treatments, as well as the quality of medical product development.
Our ability to combine medical informatics with the augmented intelligence of our world-class data scientists allow us to track, interpret, and predict what works for unique and diverse patient populations. DCTs allow us to meet patients where they are—regardless of race, gender, socioeconomic status, or ethnicity.
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