A Systems Approach to Improving Clinical Trial Informed Consent Forms in Lung Cancer Clinical Trials

A Systems Approach to Improving Clinical Trial Informed Consent Forms in Lung Cancer Clinical Trials
Conference Paper
King-Kallimanis, T. Chihuri, A. Ferris, U. BasuRoy
Precision Language In Thoracic Oncology, 11 September 2023
Abstract
Introduction
The informed consent form (ICF) literature is filled with ideas about how to aid potential trial participants in making informed choices. Yet, ICFs continue to grow in length with increased trial complexity and remain dense documents. In our review of lung cancer ICFs presented at WCLC 2022, we reported that these ICFs did not meet the regulatory requirement of being written at an 8th grade reading level. Building on that work we explored, from a systems perspective, the barriers to implementing a patient-centric addendum summarizing key information to the ICF.
Methods
We solicited key stakeholder feedback in three stages to understand barriers and facilitators to creating an addendum. Three stages of work are described. 1. Industry roundtable; Presentation of our earlier work to eight companies followed by a discussion of potential barriers to implementing an addendum. 2. One-on-one research stakeholder interviews; 15 interviews including IRB chairs, legal/compliance advisors, regulators, bioethicists, research nurses and principal investigators. Each interview explored the stakeholder’s role in developing/using ICFs, information selection, and improving the ICF. 3. Patient/Caregiver online survey; open to patients and caregivers living with lung cancer. Participants were asked to read 13 regulatory requirements for ICFs and rank the six most important to them, and provide their preferences regarding the presentation of information.
Results
Industry stakeholders generally supported an addendum to the ICF. However, they raised concerns regarding how “key information” would be selected and not be perceived as “cherry picking”. This concern was raised because of internal efforts of attendees when creating summaries to accompany the ICF for their own trials. In the research stakeholder one-on-one interviews, participants involved in developing ICF language expressed a desire for a standardized form. There was no agreement on the creation of an addendum; some participants argued it is yet another document for review while others supported its creation. One participant succinctly described the addendum as analogous to the patient leaflet for prescribed medications. Surveyed patients and caregivers indicated a strong preference for information to be presented in bullet format (67%). Most participants ranked, as their first preference, the requirement of being told “What will happen during the study” (Figure).
Conclusions
Previous studies identifying methods to help with comprehension of ICFs have gone mostly ignored. By taking a systems approach through leveraging key stakeholder feedback to learn of hidden barriers, we want to ensure patients are making an informed choice to participate in clinical trials.