Word in the health care media has it that the National Cancer Institute (NCI) is changing its criteria for clinical trial participation to try to remove barriers that prevent people from signing up. It seems that fewer than 4 percent of eligible adults participate in clinical trials, according to an American Society of Clinical Oncology (ASCO) article. This lack of buy-in to one of the fundamental processes that helps to advance our medical knowledge is hampering progress in a whole range of diseases, not least of which is cancer.
The roadblocks the NCI has in its sights are things like expense (a portion of which is borne by the participant), the exclusion of patients with health issues in addition to the one that is the focus of the trial (i.e. HIV or Hepatitis C infection) and physician assumptions about patients and their circumstances that would make them inappropriate for trial participation. I think they're missing a biggie: fear and mistrust.
I have a suspicious mind. I note that many children with cancer participate in clinical trials and have for a long time. That's one big reason treatment for children's cancers has improved to the point where, instead of four out of five children with cancer dying from it, now four out of five are "cured" of it. More than 80 percent of children with cancer now survive five years or more, according to the American Cancer Society—a huge increase since the mid-1970s, when the 5-year survival rate was about 58 percent.
I have long suspected that the reason children participate more often in clinical trials is, frankly, that THEY are not the ones choosing to participate. Their parents make that decision for them. The rate of participation decreases as children reach adolescence—a time of life when they might exert more control over such choices. Note the following passage from the ASCO article, “Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies”:
"Enrollment of children (under 15 years old) to clinical trials has historically been much higher than for adult cancers (over 50 percent). At the same time, mortality rates have for children have been decreasing since the 1970s, whereas for adults they have been decreasing only since the 1990s. The average reduction in the rate of mortality from 1975-1995 was 2.6 percent per year for those under 20 years old. Interestingly, the reduction was weakest among older children (15-19 years; 2.0 percent per year), reflecting other studies which have found both lower trial enrollment for adolescents and young adults with cancer and lower rates of mortality reduction."
What the lower rates of clinical trial participation for adults tells me is that we adults, when it is our own skin at stake, make very different decisions than when our children's skin is at stake in the very same set of circumstances.
Now, obviously, the higher rates of survival for children's cancers indicates that this strategy has been good, population-wise. It doesn't tell the individual tales of the many parents who lost children who participated in clinical trials that didn't work out. Those parents' losses, however, have meant that many parents today don't have to go through what they had to endure. To be fair, it's also true that many other parents of children in clinical trials got to take their children home again because the trials worked. Every parent today whose child is one of the lucky ones has the privilege of sharing in their relief and joy.
I once considered joining a clinical trial. I was carefully weighing the pros and cons from a medical point of view but couldn't make up my mind, so I asked a group of friends what they thought. To a person, they were vehemently against it. The issue of the money it would cost me came up, but the issue that became the focus of everyone's critique was that Big Pharma would be using me as a guinea pig with no real regard for my personal health and with every intention of profiting off my participation. That's the attitude a lot of people have about clinical trials. But not all....
When I had just been diagnosed, I struck up a brief conversation with an older man and his wife who had gotten on an elevator with me at the cancer hospital. He had some kind of immanently terminal cancer. They both knew he was dying. He had decided to spend his final months of life participating in clinical trials—not to try to save his life, but to be a part of research that might save the lives of others somewhere down the line. My admiration for him is boundless.
Fear and trust. That's what I think is at stake as we leave the innocent years of childhood and are able to contemplate our own mortality and make choices for ourselves. We become extraordinarily afraid of dying—afraid of what will happen if the trial doesn't work for us. There is also more than a little mistrust in there, too, I suspect. The trope that clinical trial participants are nothing more than guinea pigs for Big Pharma, who reaps all the profits but suffers few of the consequences, is a powerful one.
I don't know how to move people from a fear-based view of clinical trials, like my friends had, to a more realistic one (based on how clinical trials have worked to increase survival in children's cancer) or even an altruistic one (like the old man on the elevator). I struggle with these issues, myself. But until this shift in popular thinking can be made, the road to increase adults' participation in clinical trials is going to be a long, slow slog.