This post is by request from a long time reader:
Dear Dr. Dino:
Would you consider writing a blog entry on medical trials? Clearly medicine wouldn’t make much progress without them, but to put it in patient vernacular, they seem very scary…[Details about a specific medical condition and a chance to participate in a clinical trial that]…[I]nvolves a cutting-edge technology and drug which might at some future date be shown to cause serious, unanticipated health problems. I am at a loss trying to balance the benefits with the hazards…
…[W]ould you be willing to write a column that details an organized way of thinking about medical trials, and some of the questions that patients should ask?
Obviously clinical trials are important. Few people like the idea of being “guinea pigs” or “experimented on.” Fewer still are altruistic enough to participate with an endeavor explicitly for the benefit of others (for “science”) when there is none that will accrue to them (at least when clearly so stated. The vast majority of late stage cancer treatments fall into this category, and too often patients and families are allowed to believe it could be a “miracle” for them when it really isn’t. But I digress…)
Participation in clinical trials requires a much more detailed Informed Consent form than most routine medical procedures. These consist of pages upon pages of detailed descriptions of the proposed interventions, side effects, risks and hazards. Frankly, they work very hard to downplay the benefits, which I think is fair. Thus, a full reading of the consent form will usually provide most of the necessary information. The main thing you need a doctor for is to make sure you understand all the terminology and exactly what the form is saying.
After that, the decision really is up to you.
I understand that being faced with a long list of risks and benefits can be daunting. The old advice to write down all the pluses in one column and all the minuses in another and then see which is longer isn’t usually all that helpful in real life. I find whenever I do that exercise, I end up trying to justify the decision I really want to make.
Which means that balancing benefits and hazards comes down to very personal values; how much are you willing to risk (potentially) for how much (potential) gain? It always comes down to your gut.
But it has to be yours! Mistakes and misgivings come from trying to substitute someone else’s feelings/reasons/values for one’s own, which usually happens in high stakes decisions and people you care about a great deal. ie Older person willing to forego cancer treatment but acquiescing to kids/grandkids “You can’t die! Do it for us!” and ending up miserable.
I don’t think there is any way to “organize” those thoughts. After you’ve read the consent form and everything else you can get your hands on about the condition and the study, go with your gut, and know that it’s okay to do it that way. Ultimately, it’s a decision you do not have to justify; not even to yourself.