Mobile technology is changing clinical trial organization through increased engagement and focus on patient needs
From wellness to medication tracking to wearable sensors, mobile-based applications are drastically changing the delivery of patient-centered care. Because of these innovations, the global market for mHealth solutions is expected to reach $90.5 billion by 2022.
But the clinical trials and research industry has not fully benefitted from this rising market trend, although changes are underway.
A significant hurdle in clinical trials is patient recruitment. Researchers must determine not only how to engage with patients, but also how to quickly identify ideal study candidates. According to a recent survey by the National Institute of Health, these challenges can be conquered by creating positive awareness about clinical trials among targeted patients, engaging patients with media articles, having a dedicated clinical trial coordinator, and designing a recruitment strategy prior to study initiation. After recruitment, patient retention is emphasized, allowing researchers to stay in touch, track changes of address, and monitor progress and side effects.
Below are four best practices that are enabling leading research organizations to leverage mobile technology to achieve greater results with clinical trials:
Select the right mobile technology for your target participants
Proper planning and implementation of mobile technology is important. For example, the Louisiana Public Health Institute (LPHI) used a tablet-based platform in examination rooms to educate healthcare providers about different clinical studies and how to help patients understand the benefits and importance of each study. They also used the platform to train these providers for onboarding patient pools and identifying matches to different studies. Another clinical trial conducted for delivering weight loss programming to young adults in the U.S. saw the intervention administeredd through text and social media.
Before selecting a mobile platform, clinicians should ask themselves:
- How tech-savvy are my target participants?
- What are their relevant demographic factors (including age group)?
- Would this technology meet the approval of our ethics committee, as well as other legal requirements?
- How do we collect patient data, and how will it be accessed and processed?
- What kinds of mobile devices do participants use most frequently?
- What kinds of interventions might keep them engaged for the long term?
While clinical applications for app-accompanied randomized controlled trials (smartRCTs) are growing rapidly, there are certain legal limitations that must be observed, such as:
- Approval by the data protection officer
- Informed consent of the participants
- Data storage and privacy
- Adherence to quality standards as specified by the country’s legal system for mHealth apps
In Germany, for instance, mHealth apps are considered medical products, which must meet stricter criteria than common apps. In the U.S., the FDA treats mobile applications as medical devices, which must meet safety and privacy regulations. However, only one small category of medical applications is required to meet these criteria.
To minimize risk and ensure compliance, it is advisable for health and research systems planning to utilize mobile technology for clinical trials in order to seek the help of an expert to identify all legal requirements or regulations specified by the local or national government.
Ensure patient privacy and secure data-sharing
While the sharing of patient data is crucial to advancing clinical trials and helping future patients, it comes with its own set of concerns related to patient privacy.
REACHnet, one of the 13 Patient-Centered Outcomes Research Institute (PCORI)- funded Clinical Data Research Networks (CDRN) managed by LPHI, uses the Global Patient Identification (GPID) System, which matches patients to their medical records without revealing their identities. This allows participating institutions to compile research data for clinical studies without affecting patient privacy and to distribute targeted content to patients. Another system offers patients a secured protocol to share their data with doctors and researchers in the cloud while retaining complete ownership of the data.
Healthcare organizations must carefully design the security and privacy system of the clinical study’s mobile technology, ensuring it meets requirements and earns patients’ trust.
Design an effective patient engagement model
To increase participation from patient cohorts and quickly attain accrual targets, it’s important to design an effective engagement model that will keep patients engaged.
Various mobile technologies such as email, SMS, videos, podcasts, and visuals can accomplish this. ADAPTABLE, a study funded through a PCORI grant to understand the effects of two different daily doses of aspirin on heart attack patients, is setting a new trend in patient engagement in clinical research.
Recently, PCORnet, the National Patient-Centered Clinical Research Network, an initiative of PCORI, conducted a Facebook Live event to raise awareness about ADAPTABLE and how it is transforming clinical research and the lives of patients. By means of live story sharing, they showed the impact of ADAPTABLE on patient partnerships and innovative enrollment, recruitment, and retention strategies.
Another example is LPHI’s tablet-based patient engagement model, which engages patients in examination rooms. Participants also receive ongoing communication about opportunities to participate in studies, patient workgroups, and network governance. The platform’s ability to expand engagement and recruitment efforts outside the regular clinical setting through mobile technology made it possible for REACHnet to recruit over 5,000 patients.
Innovative mobile technologies are making clinical trials more engaging than ever, bringing information to patient cohorts in formats where they are most comfortable and leading to better patient outcomes, preventions and cures.