She sat there, leaning back in her recliner, listing off the numerous side effects she had been enduring since resuming her experimental chemotherapy agent. Nausea, fatigue, headache, poor appetite, wild swings in blood pressure, frequent dizziness.
“It’s a really hard drug for me. It takes its toll. I stand up to go do things around the house and just getting up can wipe me out. Then, I realize ‘maybe I’m not as young as I want to be!’” she explains.
She has cancer, stage four, but she tries not to think about that too much. She thinks about her cats, how well her tomato plants are doing, and how thankful she is that her air conditioning is fixed after a few days of it being out of commission. In this way, she has a lot to be happy about.
“My friends, when they hear me, they say I sound the same. Like nothing is wrong. And with how I feel most of the time, I think I’ve got to get a lot sicker before I come close to going” she laughs. “But, man... This chemo really wipes me out.”
She is one of the thousands of people that enroll in clinical trials every year, placing herself at risk by undergoing an experimental treatment in hopes of a better outcome. But that is not all that motivates her to endure the burden of her current treatment.
“There’s a selfishness to it, of course. I want it to make me better. But, what's also important is the information they get from me, what they learn might help other people one day.”
There is some important perspective to be gained from people like her and that’s an essential thing to keep in mind — she is a person. It can be all too easy to forget the genuine human aspect of clinical trials when pouring over an article’s sample size, statistical analyses, and between-group differences. But, every participant in every human trial is a person, with lives, jobs, families, and goals. And each of them is willingly exposing themselves to potential risk and burden in hopes of benefitting not only themselves but ultimately those who come after them.
The human aspect of clinical trials is why it is unfortunate when clinicians sometimes flippantly dismiss trial results under the guise of external validity concerns because they treat “people, not subjects.” Often this is less a result of genuine external validity concerns, but something said when the results contradict a preconceived notion. Further demeaning the efforts of people enrolling in clinical trials is the abundance of research malpractice such as publication bias and selective reporting.
Imagine what she might feel like, enduring the day to day effects of the experimental chemotherapy, only to later find that the trial which she and hundreds, or even thousands, of other people were a part of did not later add to the collective knowledge of medicine, but was instead left unpublished in a file drawer somewhere because the trial did not produce the desired result. Or that certain outcome measures which did not reflect favorably on the treatment in question were selectively withheld to distort the results and give the appearance of a more positive trial.
In this context, such actions are unconscionable, no? Not only does it squander the efforts of people volunteering themselves in clinical trials, but unpublished papers unambiguously distort medical evidence which misleads healthcare providers and places people seeking care at unnecessary risk. Nevertheless, these things continue to be a massive problem in medical research.
So, the next time you are reading a journal article or enrolling someone in a trial, do your best to keep in mind that the data represents people's lived experiences. The data consists of people who placed themselves at risk and took on the burden of an experimental treatment to better themselves and improve healthcare provider's ability to deliver quality care. With this in mind, it is clear that the people volunteering in clinical trials and those seeking healthcare deserve nothing less than excellence in research practice and in the application of evidence based practice in every day clinical care.
Quotes and details graciously shared with permission