Initial steps in creating a patient-centric addendum to clinical trial informed consent forms

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Published: 11 Aug 2022
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Dr Belinda King-Kallimanis - Director of Patient-Focused Research, LUNGevity Foundation, Chicago, USA

Dr King-Kallimanis speaks to ecancer about the multi-step project involving patients and caregivers, trialists, regulators, and clinical trial sponsors to streamline the informed consent process.

After a thorough analysis of their findings, some key challenges emerged along with ideas for improving ICFs.

One possible resolution strategy that patients supported would be to create a tri-fold template summarising key points of the ICF that are relevant to patients, which can be used as an addendum to the ICF.

The first step included an audit of 20 ICFs guided by U.S. Department of Health and Human Services regulations for the protection of human subjects in research.

The second step included focus groups and in-depth interviews with nine patients living with lung cancer to learn what information was critical when considering participation in a clinical trial using a hypothetical ICF to guide the conversation.

We created a multiphase study to look at creating an addendum that is patient centric to the informed consent form that is part of clinical trials.

What were your findings?

We are halfway through; we have completed phases 1 and 2 right now. So phase 1 was really people get a sense that the informed consent form is long and difficult to read but we wanted to be systematic and look at exactly where the problems are in the informed consent form. So we collected up a sample of twenty informed consent forms across lung cancer clinical trials, most of them were for advanced non-small cell lung cancer but we did have some for small cell and some oncogene driven trials as well. We reviewed those using the Code of Federal Regulation Requirements for informed consent forms from the US, not to see if they were compliant with those requirements but really to take those pieces of critical information and look at them to see how accessible they are and how they are written for patients. 

How can a patient-centric addendum improve clinical trials?

The second phase was to talk to patients themselves to find out what they thought of a hypothetical informed consent form. We asked them what pieces of information would help them be informed that you could put on one or two pages. By creating a trifold or a one- or two-page addendum that goes with the informed consent from that has really critical key information that is in bullet points, the reading grade level is eighth grade reading level so it’s accessible, it has references to other parts, perhaps, of the informed consent form so if people want more detailed information they know it’s on page 10 and they don’t have to flip through and look for it. By doing that we think that that will help people be more informed when they have to come to the end of that form and sign off on it.

Anything else you’d like to add?

I’m really excited, actually, to see where the next two phases go of the research that we’re doing. So we’ll be talking with other stakeholders and presenting the findings to them so that we can get their feedback because there may be some things we don’t see that might be a barrier to implementing such an addendum to the informed consent form. Then I’m really curious when we create a hypothetical trifold to sit down with patients and talk to them about it and get their feedback so that we can further refine it. 

It’s really nice to have patients involved in each step of the process so that we really are making sure that they’re giving us information so that we can then utilise it and feed it back into the clinical trials.