Informed consent forms for lung cancer trials too long and complex for patients

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Published: 11 Aug 2022
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Dr Upal Basu Roy PhD MPH - Executive Director of Research, LUNGevity Foundation, Chicago, USA

Dr Upal Basu Roy PhD MPH, the Executive Director of Research at the LUNGevity Foundation speaks to ecancer on informed consent forms for lung cancer clinical trials and how it may be a barrier to informed trial participation.

The 20 ICFs reviewed were from phases 1, 2, and 3 clinical trials covering predominantly non-small cell lung cancer -- 60% were global trials. Most of the legally required CFR topics were covered. 

However, the forms were long, ranging between 15-34 pages, with an average length of 21 pages. Readability varied by section but the average reading level across section was 10th grade, whereas the average US reading level is 8th grade. 

The second step of the study was the qualitative research component in which participants were presented with a hypothetical ICF. Participants generally noted feeling “overwhelmed” by the hypothetical ICF.

It was noted that “a lot of information was good” but that important information for deciding whether to participate was often too hard to find. When asked the intent of the forms, one participant noted “to cover their butts”.

The idea of an addendum that provides a summary with reference to page numbers in the ICF for more details was well received by participants.

The next phase of this work is to develop a tri-fold addendum and test it with patients and caregivers.

First of all, thank you so much for having me. My name is Dr Upal Basu Roy and I am the Executive Director of Research at LUNGevity Foundation. We are a United States patient advocacy group serving the lung cancer community and we have a global footprint. 

Three years ago LUNGevity started on this project where we wanted to make clinical trials more patient-centric. As a part of that project we went and interviewed eight patients who had been on clinical trials and asked them, ‘Can you walk us through the process of how easy it was, how difficult it was, what was missing and, equally importantly, what could have been done differently to make your decision-making process easier?’ We went through this entire process right from the point of a patient finding a trial to taking it to the oncologist and then talking to the trial nurse, getting onboarded, going through the trial process and the trial ending. Obviously, you can imagine, there were a lot of pain points in this process but one of the key things that jumped out to us was when we heard patients saying that the onboarding process could be easier if they were given more information. 

They were also very, very cognizant of the fact that the trial nurses, you have a finite amount of time so they cannot give you all the information. They told us, you know what, if we had the informed consent form a little bit more detailed, a little bit more written for us, a lot of the information that we would be looking for could be found in the informed consent. One of the patients actually told us, ‘You know what, sometimes we’re given the form on a Friday and we have to make a decision by Monday.’ So making the form easier, that was the genesis of the project.

The genesis stems again from this overall big initiative the LUNGevity Foundation has – streamlining clinical trials for patients – which is what brings us to the project that Dr King-Kallimanis talked about – how can we make informed consent forms more readable and more accessible for the patient community?

What were your findings?

Again that’s a very good question. For me, there were a lot of key findings but what was really surprising, for me, was the fact that… Maybe to take a step back, we audited, we analysed twenty informed consent forms and we sampled a spectrum of different lung cancer trials, right from phase III to phase I and even a single patient IND, because we wanted to get a sense of whether these forms are written differently. But one thing that consistently stuck out to me was the amount of importance that was given to this particular part of the trial, which is what happens if the trials fails or what happens if the trial stops. 

I’ll take that back to the initial patient interviews that we did. It tied back very nicely with the same concern that as a patient if I’m on a trial what happens if the trial stops? What happens if I am the patient who is doing really well on a drug but if the trial is stopped because of futility does that mean that I will stop receiving the drug? So that, for me, was very, very surprising. I think closing the loop for a patient through the informed consent form is incredibly important.

How can a patient-centric addendum improve clinical trials?

The reason being if Belinda and I had a magic wand we would clean up informed consent forms directly. But we are also realistic and we know that each pharma, each sponsor has their own template for an informed consent and it is very difficult for us to tackle individual informed consent forms. So then the next best solution is really creating an addendum and the addendum would serve not to make patients expert in a particular clinical trial, the goal of the addendum is to really make sure that patients have access to, at the tip of their fingers, the most pertinent information they need to navigate the trial which is can I take a decision today to participate in the trial? What happens if these different situations arise? What happens if I have side effects that I need to deal with? What happens if I’m feeling sick in the middle of the night? Who is going to pay for the trial? What am I responsible for in terms of financial commitment to continue to participate in the trial? So very, very specific questions that are really top of mind for the patient community. 

An addendum can help answer those questions quickly and in an accessible fashion because, again, keep in mind that they’re 21-, 25-page forms. A lot of that is legalese and the average patient does not care about the legalese. So the addendum is all about extracting what is pertinent, putting it in a patient-friendly language because Belinda talked about the readability – a lot of forms are not written at an eighth grade level. So making sure that the addendum has necessary patient information at a reading level that patients can easily access when they’re making these different decisions during the trial journey. 

I would not just say as a lung cancer patient advocate in research, I think pretty much all oncology trials, pretty much all clinical trials, we are very dependent on the patient community for really advancing science. If we use something like an addendum, if we make the informed consent process more easy, more seamless, more participatory, more engaging, as Belinda pointed out, this entire process was conceptualised in partnership with patients. Right from the informed consent process if we really, really make patients partners in the research and clinical trials the value proposition is much more clear and we’ll have a much more healthier clinical trial ecosystem. That is really what our goal is, to make patients be absolute partners in this process. That would be the impact of doing something like this.