Informed Consent Forms Lacking Patient-Centric Information

By Leah Lawrence - Last Updated: August 29, 2022

Variations in the format of informed consent forms (ICF) make it difficult for patients to make an informed decision about clinical trial participation, according to a report presented at the IASLC Conference on Lung Cancer in Vienna.

Bellinda King-Kallimanis, PhD, Director of Patient-Focused Research at LUNGevity Foundation in Bethesda, Md., explained that the purpose of the ICF is to outline risks and benefits of an interventional clinical trial to a patient. However, most ICFs are written using scientific jargon, are long, and include extraneous information not pertinent to the patient (eg, legalities of trial participation).

King-Kallimanis and colleagues conducted a multi-step project involving patients and caregivers, trialists, regulators, and clinical trial sponsors to streamline the informed consent process.

In the first step of the project, they audited 20 ICFs guided by U.S. Department of Health and Human Services regulations for the protection of human subjects in researchers.

The 20 ICFs reviewed were from phases 1, 2, and 3 clinical trials covering predominantly non-small cell lung cancer – 60% were global trials. Most of the legally-required CFR topics were covered. However, King-Kallimanis noted that the forms were long, ranging between 15-34 pages; the average length was 21 pages. Readability varied by section but the average Flesh-Kincaid Grade reading level across sections was 10th grade. In contrast, the average US reading level is 8th grade.

The second step of the project included focus groups and in-depth interviews with nine patients living with lung cancer. This step was designed to help the researchers learn what information was critical when considering participation in a clinical trial using a hypothetical ICF to guide the conversation.

Participants generally noted feeling “overwhelmed” by the hypothetical ICF. It was noted that “a lot of information was good” but that important information for deciding whether to participate was often too hard to find. When asked the intent of the forms, one participant noted “to cover their butts.” The idea of an addendum that provides a summary with reference to page numbers in the ICF for more details was well received by participants. The next phase of this work is to develop a tri-fold addendum and test it with patients and caregivers.

“While ICFs place greatest emphasis on trial procedures and risks, variations in ICF architecture and readability make it difficult for patients to make an informed decision to participate in a clinical trial,” King-Kallimanis reported. “Our study implications extend beyond lung cancer, highlighting key areas for improvements to the ICFs and providing a clear roadmap for developing a patient-centric addendum for ICFs in all cancer clinical trials.”

In her summary, King-Kallimanis said that there is enormous opportunity to become more patient-centric on the content, use of language, and layout of ICF.


Initial Steps in Creating a Patient-Centric Addendum to Clinical Trial Informed Consent Forms