A recent survey has shown that informed consent forms used for lung cancer trials are too long and complex for patients. The results of the first two parts of the survey are being presented at the 2022 World Conference on Lung Cancer.

The research suggests the layout of these forms can make it difficult for patients to find the information they need, and the forms could be improved by a patient-friendly section highlighting key points.

Part 1: Evaluating the forms 

In the study, the researchers looked at 20 informed consent forms to evaluate what information is being presented and how it is presented, as well as whether the forms can be understood by patients. The forms were provided by pharmaceutical companies (11), academia (5), and a patient organisation (4).

The researchers found that the forms were generally too long and complex. The average length of the forms was 21 pages (range, 15-34). The average required reading age was 15-16 years, but the average American reading age is 13-14 years.

Topics covered in all the forms included the purpose of the trial, what patients can expect to happen, benefits of taking part, the confidentiality of the information, contact information, and the fact that the trial is voluntary.

What would happen if the trial failed was not covered in 14 of 20 forms. Information covered later in the forms (about 10 pages or more) was trial risks, the voluntary nature of the trial, the benefits of the trial, contact information, termination information etc.

Part 2: Patient input

When asked what information they would like to see included, patients said:

  • A clear explanation of eligibility criteria
  • A note that the study is optional
  • Information on what is being tested and what the patient can expect as treatment (for example, experimental therapy vs standard care)
  • Where the trial is happening so the patient knows how much travel is involved
  • A brief privacy statement
  • An explanation of the protocol that outlines how the treatment is given and how frequently
  • The duration of the study and what comes after study treatment is finished.

They also requested a summary page listing page numbers to help look up key study details more easily, and they asked that all contact information be included in one place. Information should be outlined clearly, with no dense paragraphs and greater use of bullet points.

Part 3 of this study is assessment of the informed consent form by stakeholders, along with a 1-2 page addition to summarise key points for patients. In part 4, the addition will be amended by the inout from patients and carers.

Read more in Cancer Therapy Advisor here