The Language of Clinical Trials

The Language of Clinical Trials

Don S. Dizon, MD, FACP, FASCO

Oct 30, 2018

I am a big proponent of clinical trials. I think everyone should have access to them and any trial that they qualify for should be offered – regardless of whether or not I think they are “appropriate” (however one chooses to define it). It’s not only good medicine, but now some data from SWOG shows that access to trials may help address the disparities in cancer care and outcomes.1

Still, I find myself cringing during research meetings. It’s happened at all of my institutions too. It’s not a moment that occurs during the discussion of a trial or during the consent. I find all the research assistants and nurses that I have ever worked with to be some of the most dedicated and most empathic people I have ever worked with. They have always sensed the stress patients feel on being offered a trial and have uniformly worked to reduce the anxiety. They do their part to ensure necessary information is discussed and that patients have gotten a chance to ask questions before even one signature is obtained.

No, it’s after the consent process is complete and screening commences. To be honest, oncologists and research staff spend a lot of time even before we offer trials to patients to make sure that the patient fits the basic eligibility requirements: not too many prior lines of therapy, organ function that seems not “too abnormal”, and medications that may or may not pass muster. Still, even with all the preparation work and time spent during consent, we and our teams must spend hours after consent to ensure all eligibility criteria are met. It’s the proverbial “nitty gritty” of trial enrollment, and it’s not a formality. Some patients, even despite our most diligent work prior to consent, do not meet criteria to enroll. And this is where I cringe because, without exception, we refer to the situation as a “screen failure”.

I’ve written before how powerful the language of oncology is – especially when heard by our patients. I have even written about the impact on my own patient after I told her she had failed treatment. Yet, I have come to the conclusion that the language of oncology also matters in our own conversations, far from the ears of our patients. I think that referring to patients as screen failures dehumanizes them and belittles the process of clinical research. After all, one cannot fail a trial that she has not had the opportunity to participate in, right? We are also asking our patients to join us in a research program as partners towards progress – how then, can they be the failure? Perhaps it is us who have failed them.

Much is happening on a national level spearheaded by ASCO and the Friends of Cancer Research. We are asking hard questions as to why certain criteria are used, and as investigators, we are being asked to justify the criteria we use. It’s an important step, especially as we aim to make our trial results relevant to our patients who live in the real world: to make them not only internally valid, but generalizable.

Perhaps more importantly, I think we do a disservice to our teams when we continue to allow terms like “screen failures” as a part of normal lexicon of clinical research. Often, we work with clinical research assistants and associates who have aspirations beyond what they are doing right now – to become physicians, scientists, nurses, and researchers themselves, and to hopefully make a difference in cancer care in their own time. I want them to see the humanism in medicine, to immerse themselves in difficult conversations and see both the encouraging results and the disappointments of investigational therapies. It is my belief that as much as our actions can be transformative, so too can our words. As a result, I will continue to consciously use the term “patients with cancer” and not “cancer patients”, and when it comes to trials, refer to patients who don’t meet the criteria for trial enrollment as just that – not as a failure… of any kind.


  1. Unger JM, Moseley A, Symington B, et al. JAMA Netw Open. 2018;1(4):e181235.


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