Lengthy informed consent forms for cancer clinical trials tough for patients to navigate
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Informed consent forms for interventional oncology clinical trials are often lengthy and written at too high of a reading level for some patients, making it hard for them to weigh the decision to participate, according to study results.
The findings, presented during International Association for the Study of Lung Cancer World Conference on Lung Cancer, indicate opportunities exist to make the forms more patient-centric with regard to content, use of language and layout.
Rationale and methods
The idea for the study resulted from a scientific and clinical roundtable initiative focused on streamlining clinical trials, Bellinda King-Kallimanis, PhD, director of patient-focused research at LUNGevity Foundation, told Healio.
“After speaking with patients, we learned that the informed consent process could be easier, and so we wanted to make the informed consent form more accessible for patients,” King-Kallimanis continued. “Each sponsor or institution has their own template for informed consent forms, making it too difficult to change. Although we cannot change the forms, we can influence the creation of a template addendum that helps patients navigate the consenting process.”
Researchers conducted an audit of 20 informed consent forms for phase 1, phase 2 and phase 3 clinical trials of non-small cell lung cancer — guided by HHS 45 Code of Federal Regulations Part 46 regulations — and conducted focus groups and in-depth interviews with nine patients with lung cancer to assess what information was critical when considering a hypothetical informed consent form.
Key findings
Researchers found that although the consent forms covered most of the legally required topics, they had an average length of 21 pages written at an average 10th-grade reading level, whereas the average U.S. reading level is eighth grade.
Results of the qualitative research component of the study in which researchers gave patients a hypothetical informed consent form showed all patients reported feeling “overwhelmed” by the form and that important information was too hard to find.
Of note, study participants favored the idea of an addendum that provides a summary with reference to page numbers in the consent form.
Next steps
King-Kallimanis and colleagues will present the results of the audit at a future stakeholder roundtable to prioritize best practices and discuss a template addendum to the informed consent forms summarizing key points for patients considering enrolling in a clinical trial.
“There is a lot of room to make the informed consent process more patient-centric, and something as simple as an addendum that serves as Cliff notes to the longer informed consent forms is one possible solution endorsed by patients,” King-Kallimanis said.
“We plan to speak with other trial stakeholders to present the findings from our first two trial phases to learn where there could be any barriers to implementation,” she continued. “Then we plan to create a hypothetical trifold addendum to the hypothetical informed consent form, and we will debrief that with patients and caregivers. Finally, we plan to embed the addendum within a clinical trial where a group of patients receive the trifold addendum and another group is consented as per usual. We would like to compare how both patients and trialists felt with respect to the process and how informed the patients felt when signing the informed consent forms.”
References:
- Informed consent forms for lung cancer clinical trials may be a barrier to informed trial participation (press release). Available at: www.iaslc.org/iaslc-news/press-release/informed-consent-forms-lung-cancer-clinical-trials-may-be-barrier-informed. Published Aug. 9, 2022. Accessed Aug. 16, 2022.
- King-Kallimanis B, et al. Abstract MA08. Presented at: International Association for the Study of Lung Cancer World Conference on Lung Cancer (hybrid meeting); Aug. 6-9, 2022; Vienna.
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King-Kallimanis B, et al. Abstract MA08. Presented at: International Association for the Study of Lung Cancer World Conference on Lung Cancer (hybrid meeting); Aug. 6-9, 2022; Vienna.
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