Ongoing concerns about clinical trial participants’ lack of understanding of the Informed Consent process has prompted Icon to sponsor a series of research projects at Carnegie Mellon University (CMU) to find better ways to improve comprehension, including the use of multimedia tools and advances in behav­ioral decision research.

The multi-year collaboration is led by Baruch Fischhoff, Ph.D., a cognitive psychologist by training, whose research focuses on risk communication, analysis and management, Informed Consent, security and environmental protection. Considered a leading authority on behavioral sciences in healthcare, he is a CMU professor in the de­partments of social and decisions sciences and engineering and public policy.

“When a patient thinks about the in­formed part of the consent form, our focus is to help that individual to make his decision as clearly as possible, because if he feels a reasonable amount of pressure to sign when he does not fully comprehend it, then some­thing is wrong,” said Fischhoff. “So we—a pair of my colleagues and I—are working on better ways to think about the communica­tion challenge and better ways of executing it to ensure patients understand the benefits and potential risks of joining trials.”

Although the Icon-CMU research was announced just last week, Fischhoff said his team has been collecting information about clinical trials since mid-2014 to better under­stand how patients make decisions based on disclosed information, their understand­ing of it, its significance and the ability to use that information in the reasoning that leads them to make a clear choice.

“I approach this problem as something new, having reviewed research from various resources in the public domain including the National Science Foundation and the National Institutes of Health, and we are starting to do our data analysis,” said Fischhoff, who chairs the FDA’s Risk Communication Advisory Committee and has co-authored or edited seven books, including Communicating Risks and Benefits: An Evidence Based Guide, in 2011. “To ensure that patients understand the potential risks and benefits of joining trials, our research will take advantage of advances in behav­ioral decision research and information technology.”

Icon, which uses research tools from its Firecrest unit’s suite of products to provide investigator training, patient recruitment and support systems, already incorporates multimedia technology to improve com­pliance. The CMU research projects are designed to scientifically test, measure and validate what patients need to ensure In­formed Consent, said Frances Abeton, vice president of Firecrest.

“Clinical trials are complex, and the mes­sages and details are foreign to the majority of patients,” said Abeton. “We don’t have concerns per say. Rather, we want to em­power patients and ensure we are delivering the information they want and need in a way that’s easily consumable, while improv­ing comprehension and retention.”

The FDA’s recent proposed draft guid­ance outlining the use of electronic Informed Consent (eIC) for trials, she said, came after Icon had begun its eIC activities, including the CMU collaboration.

“Our orientation was focused on em­powering the patient from the outset,” said Abeton, adding concerns about improving understanding of the Informed Consent process is a global challenge Icon aims to overcome through research. “We also want to know how the presentation of clinical trial information affects patient understanding, confidence and trust.”

In its draft guidance, the FDA addresses the clinical research community’s interest in using computer-based technology to provide critical information about a trial to better evaluate participants’ comprehension and document their consent.

By contrast, Icon and CMU are more fo­cused on how patients handle risk commu­nications and make comparisons between the risks and benefits of various options to make informed medical decisions.

Icon’s push to become tech savvy stems, in part, from last year’s acquisition of Aptiv Solutions, which develops software and IT capabilities around trial monitoring, and its acquisition earlier this month of MediMedia Pharma Solutions, which provides scien­tific communications and market access.

“We believe Professor Fischhoff’s research experience and publications are groundbreaking in patient understanding,” said Abeton. “This evidence-based approach is what Icon desired to innovate our product suite.

After scientific peer review of Fischhoff’s research findings, the results of his stud­ies will be published and accessible to the public. Icon said those results will influence development of new Icon innovations, in­cluding a range of study management tools from Firecrest.

Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 19, Issue 12, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »