One essential component of participation in clinical research is the informed consent process. Before someone enrolls in a research study, before any procedures are conducted, they must understand important details about the study so that they can make an informed choice about participating. Legally, that means they must sign an informed consent document.
But absorbing all that information all at once can be overwhelming. So, as part of our efforts to make clinical research better, we are providing some of those study details online. The intent is for people to be able to be "informed" before they go for that first screening visit, where they sign the "consent."
This new feature is called Trial Visit Overview. Here's a peek:
Study information that was already available on LillyTrialGuide.com includes the study purpose, key entry criteria and locations of participating research centers. Trial Visit Overview takes it a step further, providing more details about the visit schedule, how long each visit might take and what procedures will be conducted at each visit.
With health literacy concepts in mind, we tried to avoid using complex medical terms and jargon and opted instead to illustrate study procedures using icons and symbols rather than words.
We know that people's time is as precious as their health, so we designed Trial Visit Overview to help them understand how study participation may affect their daily life. Having this information up front can allow someone to say “yes” to participation and make them more likely to actually complete the study. On the other hand, it could help them to say “no” to participation right away, without wasting their time in trying to enroll or agreeing to study visits that don’t work for them. Either way, it's our goal to provide the right amount of information to people at the right time so that they can make a fully informed decision.
We have added this feature to two clinical trials: a study of ixekizumab in people with nonradiographic axial spondyloarthritis and a study of tadalafil in pediatric patients with pulmonary arterial hypertension (PAH). You can link to Trial Visit Overview from the study’s main page:
We're just in the pilot stages of this new feature, so we welcome your input. Take a look at the Trial Visit Overview tool and let us know if you think this additional information would help people make a more informed choice about participation in research studies. Provide your comments below or @LillyTrials on Twitter.