In the January 2018 issue of Clinical Researcher (online January 16), special feature contributor Ann Neuer, MBA, president of Medical deScriptions, LLC, writes that mobile technology is gaining a dynamic foothold in the clinical trial process, not only for sites, sponsors, and contract research organizations (CROs), but also for patients.
The January issue covers the theme of “All Hands in On Recruitment and Retention,” and challenges readers to consider who needs to be involved in finding and communicating with candidate participants from the sponsor, CRO, study site, and patient advocacy organization angles. How about everybody?
Even patients need training for this new reality, Neuer found as she researched her article on “Patient Engagement Goes Mobile.” Although not included in the online article, she provided an example of a site network conducting a study that involved BYOD—Bring Your Own Device. The study used an app designed for mobile devices, such as smartphones and tablets.
At the investigator meeting, Neuer says, there was very little training on the app, so during the initiation visit, the clinical research associate (CRA) offered additional instruction in how to use the app and how to train and engage the patient.
Investigator Perspectives and Insights on the Use of Mobile Tech in Clinical Trials: Findings from CTTI’s Mobile Clinical Trials Project – Join us at ACRP 2018 to learn about new research from the Clinical Trials Transformation Initiative (CTTI). Hear insights on the advantages and disadvantages to be aware of when running a trial with mobile technology, budgetary and training needs, and other important factors for site personnel to consider. View Session Details
Given that this was a new approach, what happened next is hardly surprising, Neuer explains. There were tremendous technical challenges due to the fact that patients had many different types of devices, resulting in an inability to download the app because of fire walls or to see material on their screens. Further, for some patients to use the app, they had to provide personal data. Because the study coordinators had received only minimal training, they were ill prepared to help patients manage these technical issues.
The site network shared this feedback with the sponsor, noting that the technical issues could not be handled by the Help Desk, which was an outsourced vendor.
The whole scenario did little to promote patient engagement, and patients were not happy, Neuer says. As a result, the sponsor decided to put the study on hold and determined that the CRA was not the best person for teaching study coordinators how to present the app to patients. The sponsor did schedule another technical training, and ultimately delayed study initiation for three months.
This was a tough lesson for the sites and the sponsors, Neuer says.
As a reminder, Clinical Researcher is now a digital-only publication. You can find the January 2018 issue on the Clinical Researcher page of our website when it goes online next week, as well as back issues of the journal dating to its April 2014 debut under the current name.
Edited by Gary Cramer