Who Enters a Trial?: Patient Care and Equipoise

Who Enters a Trial?: Patient Care and Equipoise

Don S. Dizon, MD, FACP, FASCO

@drdonsdizon
Apr 17, 2018

Originally published in "Discussions with Don S. Dizon" on The Oncologist.

In the second week of April, I headed to San Francisco where I took part in the SWOG Semi-Annual Meeting. To those who might be unfamiliar with us, SWOG is a member organization of the National Clinical Trials Network (NCTN) and is tasked in running clinical trials across disease sites and scenarios, from prevention to treatment to survivorship and palliative care. Those involved in SWOG come from across the country twice a year to meet, learn, teach, and plan—all of this in the most interactive and inclusive way possible. Thanks to the leadership in our Patient Advocacy group (shout out to Wendy Lawton and Rick Bangs!), patient advocates, who are embedded more and more into aspects of trial design at its earliest point, are important contributors to this meeting.

The goal is to launch clinical trials across the country, and once that happens, to ensure they successfully accrue. We spend a lot of time trying to improve accrual—making sure our investigators open as many trials as possible, supporting them once that happens, and then raising awareness among our patients, communicating in a way that is straightforward and clear, without overly relying on scientific and technical lingo. As I prepared for the SWOG meeting, I was reminded of one thing: that we as clinicians can sometimes be our own barrier to trial accrual.

I recall one instance when I was in a tumor board. The case of a 70-year-old patient with breast cancer was presented: 1.0 cm grade 2 tumor with one of five positive lymph nodes, hormone receptor positive, HER2-neu negative. We discussed treatment and I still remember the spirited debate that followed. Some felt chemotherapy was a “no-brainer” while others felt very strongly that endocrine therapy was sufficient and that chemotherapy would add very little. At the time we had the TAILOR-Rx trial open, one that was prospectively evaluating the use of the 21-gene Recurrence Score. One of my colleagues had suggested talking to her about this trial.

I thought it was a great idea. In fact, it was more than a great idea—it was the most appropriate option. The situation this patient found herself in was clinical equipoise: the situation where we, as clinicians, are unsure whether treatment (or which type of treatment) provides benefit. In such a situation, there is no good evidence to guide decisions, and in reality, we make recommendations based on what we believe to be in the best interests of our particular patient and our own particular anecdotes from patients we might have treated in a similar situation.

I expected that everyone would be on board with the option to offer her the trial, but there was no unanimous consensus. Some felt it would be “not in the interests of the trial” to enroll someone “at her age,” and others thought it would be “unjust if she had to take chemotherapy.” Others felt it was fine to put her on trial because “if she didn’t like her treatment assignment, she could always withdraw.” 

A few of us listened to this conversation, with each provider speaking from the point of what they truly felt was in the best interests of this patient. Ultimately, one of our most seasoned providers spoke up. “If we, as a group, feel we know the answer,” he asked, “why are we doing a trial?”

That seemed to stop everyone. “The point,” he continued, “is to go beyond anecdotes, to actually provide an evidence basis, isn’t it? In order to do that, we can’t cherry pick the patients we place on trials just like we cannot make any one patient do a trial rather than standard of care.” With that, consensus was reached. Ultimately, the patient was offered the trial and agreed to participate.

Clinical trials are the pathway to better treatments, better outcomes, and a future without cancer. It’s not enough that trials are designed to answer important questions, or that the options for trials are available for our patients. We, as investigators, need to believe in them, and be willing to offer them to all patients who are eligible. Too often, we (myself included) make determinations that patients are best served off a clinical trial, even though they are eligible. I think we have to be cognizant of our own biases, in practice and when it comes to trials. If we hope to make expeditious progress, we have to believe there are questions we must answer, together.

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