Informed consent forms used for lung cancer trials are too long and complex for patients, according to research presented at the IASLC 2022 World Conference on Lung Cancer.

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

“All the patients we spoke to endorsed the idea of an addendum summarizing the most important information,” said investigator Bellinda King-Kallimanis, PhD, of the LUNGevity Foundation, when presenting the research at the conference.

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Dr King-Kallimanis presented parts 1 and 2 of a multi-part study investigating the effectiveness of informed consent forms for clinical trials. 

Part 1: Evaluating the Forms 

For the first part of this study, the researchers audited 20 informed consent forms to evaluate what and how information is being presented, as well as whether forms are comprehensible. 

The consent forms were associated with phase 1, 2, and 3 lung cancer trials, as well as an expanded access program and a single-patient investigational new drug request. Forms were provided by pharmaceutical companies (n=11), academia (n=5), and LUNGevity patients (n=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 level for the forms was 10th grade, but the average American reads at an 8th grade level.

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

The topic with the least coverage across forms (included in 14 of 20 forms) was information on what would happen if the trial failed. 

Information that was provided later on in the forms — 10 or more pages in — included foreseeable risks, the fact that the trial is voluntary, benefits of the trial, costs, contact information, alternatives, and information about trial termination.

Part 2: Patient Input

In part 2 of the study, the researchers conducted 2 focus groups to determine what information patients need to make an informed choice. One of the focus groups consisted of participants who have enrolled in clinical trials, and the other group consisted of individuals with no prior trial experience. 

All participants supported an addendum to consent forms that highlights key information. When asked what information they would like to see included, participants 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. 

The participants also requested a summary page that lists page numbers to allow readers to look up key study details more easily, and they asked that all contact information be included in one place. 

In general, participants requested that information be outlined clearly, with no dense paragraphs and greater use of bullet points.

Based on these findings, Dr King-Kallimanis concluded that “there is such an enormous opportunity here to be more patient-centric in the content, use of language, and the layout of these forms.”

For part 3 of this study Dr King-Kallimanis and colleagues will present the focus group results to stakeholders and discuss a 1-2 page template addendum that summarizes key points for patients. In part 4, the researchers will use patient and caregiver input to refine the addendum. 

Disclosures: Dr King-Kallimanis declared affiliations with AstraZeneca, G1 Therapeutics, Bristol Myers Squibb, Merck, BluePrint Medicine, Eli Lilly, Genentech, Takeda, Jazz Pharmaceuticals, and Novartis.


King-Kallimanis B, Ferris A, Dropkin L, Molina M, Redway L, Roy UB. Initial steps in creating a patient-centric addendum to clinical trial informed consent forms. Presented at WCLC 2022. August 6-9, 2022. Abstract 240.