In 2011, Mary Elizabeth Williams was diagnosed with metastatic melanoma, a finding that usually means a patient has six to seven months to live. Knowing melanoma doesn’t respond well to traditional cancer treatments, she decided to take a chance on a phase I immunotherapy trial of a new drug. Williams wrote about her experience in her book, A Series of Catastrophes and Miracles: A True Story of Love, Science and Cancer. It was a journey, she says, from last resort to hope and possibilities.

Lindsay McNair, chief medical officer of WCG, spoke with Williams in a webinar last week, discussing the patient perspective on clinical trials, what they do right and how to change what they do wrong.

Q: Given your options — treatment that didn’t offer a good success rate, death or participating in a clinical trial — do you feel that you were well informed on your options and what participation in a clinical trial entailed?

A: At the time, Yervoy (ipilumumab) was a very new drug on the market and had a 30 percent success rate. It’s scary embarking on a course of treatment for which there is very little precedent. There were not a lot of human subjects who had come before me, and I knew that the risks could be great. There was a risk, not only of it not working, but of dying from the treatment, which did happen to some people on this trial. I had great conversations with the immuno-oncology team and they were very clear about why I would be right for this trial. It was a choice that was made, not just based on the drug and the cancer, but very much on the patient. And that was a turning point for me — that I was being listened to and that I was going to be collaborating with a group of people who believed in me as a patient.

Q: When you were approached about the trial — the informed consent process — what was the hardest thing for you to understand as people started to talk to you about what the trial entailed, etc.?

A: My understanding of clinical trials was limited, and my understanding of immunotherapy was nil. I had a lot of questions and concerns and there was a lot for me to process. My oncologist did the best she could in terms of explaining treatment. My initial conversation with the immunotherapy team at Memorial Sloane Kettering was the first time that I really felt that maybe I wasn’t going to die. That maybe treatment in a clinical trial would work, but with the understanding that maybe it wouldn’t. I was in a state of desperate, deep panic. I had a conversation with someone who said that maybe participating in a clinical trial didn’t have to be a last resort for me. Maybe it could be my first resort. And that really changed the game for me.

Q: How much of your information and your understanding about what the study would entail for you came from the process, this conversation you had with study team members as opposed to literally reading the paper document that you were handed?

A: I had an initial meeting with a nurse. I was handed the document, and we sat down together and the expectation was that I would sign it on the spot. Even though we went through the document thoroughly, I remember feeling that I would have to sign the document whether I fully understood it or not. I also recognize that there were a lot of things that just couldn’t have been understood at that time because it was such a process and a new form of treatment, but I am really struck with how vulnerable I was, how much I didn’t know and that there was such an expectation of me. And I don’t know, in retrospect, if there was a lot of understanding by the study team that I was not fully competent. I wasn’t. I was a complete mess — physically, mentally, emotionally. These decisions often need to be made under very difficult circumstances, quickly, and you do the best you can with the timeframe that you have. But I recognize now how hobbled I really was. And I don’t think that is unusual.

Q: How do you believe that the informed consent form and process in a phase I trial should talk about the possibility of benefits? How should we express the truth about the odds of success in a very early study, which are low, but still leave people with hope? How can we balance that?

A: That’s a very difficult question especially because in phase I trials, there is not a whole lot of expectation of success. My consent form was pretty clear about that. I felt that I had an understanding that there was a hope of success. But at that point, we were not talking about the word cure. There was no evidence of possibility that I would have all of my disease eradicated. It was really just about efficacy and potential tumor reduction. That is what was communicated to me. And the bar was set low. And my expectations were reasonable.

I’m grateful that the way it was communicated to me was, “We are going to try.” It was about time rather than about the disease. That is a smart way to approach it. Maybe this is about, “We can extend your life.” Because, ultimately, that’s really what we want. I would be happy to live with tumors if it meant I would live longer. That’s what I think most people approaching cancer now are really looking at management. So, I think that’s fine to communicate it that way.

For the rest of the interview, please go to WCG’s website: https://bit.ly/2U9qzqu.