The seemingly inevitable rise of hybrid or outright virtual clinical trials with minimal or no patient site visits presents clinical trial professionals with a classic case of threat and opportunity, experts say. On the positive side, virtual trials add a flexibility to attract new potential participants and sources of data such as that gleaned from wearables. On the negative side, will it be harder to keep patients engaged and on the straight and narrow compliance pathway if most or all of the trial is conducted online?
“How can you keep participants involved without any site visits, especially for a trial that covers several years with a [relatively] non-invasive treatment?” asks Virginia Nido, global head, product development industry collaborations with Genentech.
It’s unchartered territory, and there’s no single answer to keeping patients engaged, Nido observes, but she has become a big fan of using infographics to help supplement the connection between patients and their trials.
However, infographic communications can be tricky with patients—both current and prospective—because the wrong kind of information sharing can have negative and unforeseen implications. For example, Nido was involved in a trial where she was considering showing what percentage of participants had elected the randomization track. It might sound relatively innocuous, until a member of her team pointed out that that information could sway the decision-making for people still mulling whether to join the study or other future trials.
Dude, Where’s My Data?
Join Nido at the ACRP 2020 annual conference in Seattle, May 1-4, as she describes how you can use infographics to return results to patients without breaking the blind or compromising study integrity. Participants will hear use case studies from the Clinical Trials Transformation Initiative’s Mobile Clinical Trials Engaging Patients and Sites and the University of California’s WISDOM breast health study. Understand what data can be shared with patients without compromising the study, and learn easy ways to create infographics in patient-friendly language.
Potential participants might have been influenced by the relatively low percentage of people who chose that option and might have opted to go in another direction based at least in part on that datapoint, Nido says. “It’s a common mistake [in infographics, to inadvertently] break the blind and influence future participants,” she adds.
One key to developing impactful and appropriate patient outreach infographics is to work closely with the institutional review board for the trial, Nido stresses. When presenting on this topic, in addition to her own experiences, she draws on cases from the Clinical Trials Transformation Initiative and the University of California.
Author: Michael Causey