By Ed Miseta, Chief Editor, Clinical Leader
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New technology devices and apps are poised to transform the clinical trial landscape. From patient recruitment and retention to expedited data collection, new technologies are poised to simplify trials, create a better patient experience, and hopefully bring down the high cost of trials.
Abbe Steel, founder and CEO of HealthiVibe, believes a couple trends are poised to have the biggest impact on trials. “Most definitely, the biggest breakthrough in clinical development will be the increase in patient-centric studies,” she says. “These studies are built around the patient, so they will have the effect of reducing the burden of trials on both sites and patients. Today, there are a tremendous number of channels with which to communicate with patients. The Internet and other new technologies have not only facilitated increased patients’ access to information, but enabled new pathways for patients to find and access research.”
According to Steel, the emergence and popularity of patient-centric applications provides a great opportunity for pharmaceutical manufacturers to engage patients and create a customized, direct relationship with them. Fortunately, the clinical trial space provides an excellent channel to leverage these technologies. The integration of mobile technology in new clinical trial design and business strategy development holds promise for aligning site and patient needs with faster study execution and reduced costs.
This concept is a popular new trend, and a big one for those working in all areas of IT today. “BYOD allows study participants to use an array of devices, from smartphones to FitBits, to send and receive sensitive study data,” says Steel. “While there are issues to address, including security concerns, HIPAA compliance, and a consistent user experience, I believe that BYOD could increase compliance and retention as a result of the convenience and familiarity associated with using their own devices.”
Study sites can provide patients with wireless health devices (such as glucometers) to collect biometric information directly from patients. Portable, medical devices that transmit data wirelessly can eliminate the need for some study visits. With advances in mHealth technology, the list of devices you may consider will grow, encompassing not only hand-held or wearable, but also injectable and ingestible.
Study-specific apps can be an excellent “study companion” for clinical trial patients and caregivers providing study education and documentation; study visit and medication reminders; motivation for patients to perform study-related activities and support with data collection.
If your company is considering the use of mobile health technologies in a clinical trial, Steel believes these are several important factors to consider before moving forward, and which will help you to decide if mHealth technologies are a good fit for your study.
1. What Do You Know About Your Patient Population?
Understanding the study patient population is critical in determining how practical and effective a potential technology may be. For example, while tele-medicine has been successfully used for years, some new mHealth technologies rely heavily on wireless Internet access, which may not be as readily available in certain areas of the country or the world. Part of the attraction of mobile devices lies in the patient’s comfort and familiarity in using them. If your target demographic is elderly or those with severe cognitive impairment, for example, mHealth may not be the best fit. Steel notes some patient populations may require face-to-face physician assessments or other data collection best suited to site visits.
2. Examine Your Protocol
A key consideration is whether the trial design is a good fit for mobile technologies. Steel recommends reviewing the study visit schedule to see if any of the study data can be captured remotely without the patient going to the site, and/or if mobile technology can be used for studies that require continual patient engagement for retention and increased compliance. “Ask yourself if the study will rely more on patient-reported data or investigator assessments,” she advises. “What are the necessary specimens that need to be collected and is there a mobile device that can collect that data?” These are important considerations because cost is always a factor, and mobile technologies may not be as cost effective for studies relying heavily on investigator assessments or on specimen collection in the absence of a supporting mobile device technology.”
3. Don’t Forget Data Integrity
An absolute essential aspect of any data collection model is the quality and security of that data. The level of encryption used to transfer and store the data is a crucial point to consider when selecting the appropriate type of health technology. For that reason, device-specific checks and balances are a must.
4. Enable Remote Monitoring
With mHealth technologies in place, sponsors and CROs will have the ability to monitor data remotely, via reports that sync device data with the EDC. Real-time data collection provides powerful insights regarding trends as they unfold with the opportunity to intervene if necessary, which could cut costs drastically.
5. Timely Reporting of Adverse Events
This is something regulators take very seriously and is critical to ensuring the well-being of patients. Any system you implement should include patient education about staying vigilant along with easy to follow instructions about how to report adverse events, ensuring they are reported as soon as they occur.
6. Global Requirements Will Vary
For global studies, the device selection and distribution must be tailored to in-country regulations. Applications used must be translated into the native language, and all country-specific privacy regulations must be observed. Review the regulations unique to the country in which you will implement mobile devices and talk to someone who has performed trials there to get additional guidance.
While mHealth technologies may seem like a must-have for all trials, careful consideration of these factors will help you determine if it is a fit for your study, and what benefits you can expect to accrue from it.