The Informed Consent Form (ICF) is a fundamental building block of patient experience in clinical trials. The complex content of the ICF has traditionally been a major challenge faced by potential clinical trial participants.
Now more than ever, as an industry, we are searching for ways to improve study participants’ experience in clinical trials. Focusing on patient communications in particular, we all recognize that there is room for improvement in the current Informed Consent Form (ICF). The ICF communicates complex information, but understanding this complexity can be a challenge for potential study participants. Using the UPL, we addressed the challenge by reimagining how we communicate the ICF.
We heard from patients and listened to the questions they were looking to answer.
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We started the ICF redesign process by organizing a hands-on co-creation session that brought a diverse group of people together for the first time at Bristol-Myers Squibb: former clinical trial participants, caregivers, healthcare professionals, bioethicists, visual communication experts, and Institutional Review Board directors. These diverse individuals worked together, listened to each other, and suggested improvements to the ICF and to the informed consent process. We left the session with prototypes of how the ICF could be redesigned as well as prototypes of supporting materials to supplement the informed consent process. We validated the UPL-ICF design and features with an additional set of former clinical trial participants, caregivers, and study staff. Using the feedback from validations, we finalized the UPL-ICF and supporting materials.
One of our outputs was the Role Model UPL-ICF, which can be updated and adapted to any specific clinical trial. This UPL-ICF has new elements (like a welcome letter and a table of contents) as well as improvements to the organization of many traditional sections such as the risks and procedures sections. It is written in more participant-friendly language, and the information is presented in a way that is more inviting to read. We also created two additional materials to support the new UPL-ICF.