Lack of Study Volunteers Hurting the Cancer Fight

The New York Times had an article yesterday about one of the major hurdles to advancing the fight against cancer - not enough patients enrolled in clinical trials. It raises a lot of interesting issues, including the fact that a lot of trials that are out there don't accomplish much, because they don't include enough patients or they're designed to fine-tune treatments with existing drugs.

The article points to some issues that discourage participation in clinical trials, including the fact that they typically lose money for oncologists. It's also a complicated decision to participate in a trial or pick the "right" treatment plan, of course. Here's a bit of the article discussing the treatment options for a man dealing with cancer:

Choice No. 1: no chemotherapy, no further treatment. Thirty-one of 100 patients like him who chose no further treatment were alive and cancer-free for at least five years. But 30 of 100 relapsed, and 39 died of other causes, like a heart attack.

Choice No. 2: the most aggressive chemotherapy, including 48-hour intravenous infusions of a drug with serious side effects. If he chose that regimen, he would have a 43 percent chance of being alive and cancer-free in five years. But he also had a 14 percent chance of relapsing. And he had a 44 percent chance of dying of something else.

The bottom line, Dr. Eisenberg said, is that 11 people of 100 who get this chemotherapy are alive and well because of it. But that also means that almost 9 of 10 who opt for this treatment are not helped — they either relapse or die of other causes within five years.

Choice No. 3: a less aggressive chemotherapy with a smaller improvement in survival rate.

But there was another option. He could join a Phase 3 clinical trial sponsored by a drug company, ImClone. He would be randomly assigned to receive chemotherapy with or without ImClone’s drug, Erbitux, approved for people with colon cancer more advanced than his. The aim was to find out whether Erbitux could also help those with earlier colon cancer.

“The trial may help you or it may hurt you because the drug may make you sick,” Dr. Eisenberg said.

The part about that which is probably most interesting is the breakdown in outcomes for Choice 1 vs. Choice 2. Toss in Choice 3 (a messy middle area) and the option to enroll in a clinical trial (with REALLY unknown outcomes) and the patient ends up feeling extremely overwhelmed. It's hard to imagine many people making an informed decision on this. A lot of people might think they're informed, but are they really understanding all the percentages and odds?

As I was reading this I was also thinking back to a class exercise I gave students a couple years ago in a health communication class - to design a communication strategy to get people enrolled in clinical trials for an HIV vaccine. While getting people to participate in clinical trials related to cancer is probably marginally easier (from the point of view of communication/persuasion), it's clear that there are a lot of other factors here causing additional problems.

In any case, a very good article from the NYT that comes at this problem from a lot of different perspectives.