How Informed are your Participants? RTI International Champions Patient-Centered Consent for Clinical Trials

RESEARCH TRIANGLE PARK, NC-Clinical trial informed consent forms often contain complex medical terminology and are written at a high reading level, which can confuse potential participants, reduce patient adherence to trial procedures, and lead to protracted and expensive recruitment. Some clinical trials are even delayed or suspended because they cannot enroll and retain enough participants, ultimately delaying new medical therapies. RTI International has addressed this challenge with Consenter, a patient-centered interactive informed consent application that solves the problem of clinical trial enrollment by combining communication science with digital, interactive technology.

As a non-profit research institute, RTI is firmly committed to the belief that a more informed participant results in better trials and better science. Unlike other paper-based and visual consent products, Consenter delivers an informed consent that speaks the participant’s language. Instead of reading long forms, patients engage with a customizable on-screen avatar who explains the trial process, describes potential benefits and risks, and asks questions using plain language knowledge assessments. The result is better informed patients who understand and meet their responsibilities in the trial.

Consenter also delivers all IRB-required elements during informed consent-including the study’s purpose, study procedures, and potential risks and benefits of participation-ensuring consistency across multiple sites, investigators, and institutions. This helps reduce conflicting enrollment procedures and frees site staff to focus on other responsibilities, thus improving trial efficiency and lowering costs.

“Clinical trials are under tremendous pressure to enroll patients quickly,” explains Lauren McCormack, PhD, RTI’s vice president of public health tesearch. “However, if patients don’t truly understand what they’re signing up for, they’re unlikely to stick with the trial and will probably need to be replaced midstream. Consenter focuses on getting the right patients enrolled in the right trials.”

For more about Consenter or to request a demo, visit www.consenter.org.