Struggling with extensive informed consent procedures for cancer trials—is there even a benefit for the patients?

Abstract

Purpose Informed consent procedures in clinical trials often differ in length and complexity to those in clinical routine care. Little is known about the benefit of extensive procedures as intended in clinical trials compared to procedures in routine cancer treatment. Methods In two different clinical studies performed at a comprehensive cancer center, we compared patients’ comprehension and satisfaction of current informed consent procedures in routine clinical care with the level of comprehension and satisfaction of patients treated within clinical trials. Patients with a new cancer diagnosis and recent informed consent received a questionnaire about satisfaction, comprehension, time management, and physician–patient relationship of the informed consent process. Patients in cohort 1 consented to cancer treatment within a clinical trial and were additionally interviewed in a structured way; patients in cohort 2 consented to “standard” chemotherapy and received a follow-up questionnaire after 6 months. Results In cohort 1, 82 patients completed the questionnaire and had an additional structured interview. They were treated in 41 different trials, receiving up to 40 pages of educational material. In cohort 2, 89 patients completed the first and 52 completed the follow-up questionnaire after receiving a standard informed consent form of 6 pages. Subjective understanding and satisfaction with the information provided was equally very high. However, deficits in objective understanding were observed in both cohorts. Conclusion Extensive informed consent procedures for clinical cancer trials have not been associated with a higher level of satisfaction or measurable objective understanding; therefore, the benefit seems to be limited.

Simplifying informed consent as a universal precaution

“…A critical barrier to participating in research is that participants need to be able to read and understand informed consent documents (ICD) 14 – 17 . ICD describe the study and its treatments or intervention, risks and benefits, patient obligations, and confidentiality, and are both an ethical and legal requirement for participation in clinical trials.…”

“…ICD describe the study and its treatments or intervention, risks and benefits, patient obligations, and confidentiality, and are both an ethical and legal requirement for participation in clinical trials. Most ICD require a high level of reading skill and comprehension and are often written at a level that is too difficult for many patients to comprehend 14 , 15 , 18 . As medical treatments continue to progress, ICD procedures have grown in complexity as well.…”

“…The goal of the ICD is to guarantee patient comprehension and autonomy through sufficient explanations of different therapeutic options, effects, risks, and potential side effects. However, a result of more complex clinical trials is that ICD often becomes overly long, dense, and complex 14 .…”