Clinical trials

There's a rhetorical dance I do with the docs regarding expectations for clinical trials of new drugs or new combinations of drugs.  They may say that a particular trial is "innovative," "exciting," even "promising," but they will not say "This will make you better" because the whole point of the trial is to determine whether there's an empirical basis for saying that (and then to convince the FDA.)  So nominally at least, patients like me take unproven drugs into their bodies selflessly to expand the boundaries of scientific knowledge and perhaps to help future generations of patients -- not because there's a rational expectation that the drugs will help.

Well, God bless science and future generations, but personally I'm not so selfless, or so rational for that matter.  I participate in clinical trials because I hope, if not expect, that the unproven drugs will make me better (and of course the docs, nurses, hospitals, drug companies, and everyone else shares that hope) and more particularly, because I have no better options.

The question of rational expectations is tricky.  Regarding the rate of success of clinical trials, I sometimes see the figure 1-in-10 cited -- for every 10 drugs that start the clinical trial process, the FDA ultimately approves one.  But that varies widely based on the type of drug, trial, and disease, and it may not say anything about whether any individuals participating in the trials actually benefited, even if the drug was not ultimately approved.

In my case, I've participated in five clinical trials with a variety of approaches testing new drugs or new combinations of previously approved drugs. And some of these new drugs may have helped me -- for the moment I'm still here, despite rational expectations to the contrary. But it is hard to know why. I do know that my treatment options still remain limited, that very smart people are expanding the boundaries of science in the search for new cancer-fighting therapies, and that my best hope (if not expectation) is to find a trial that will make me better.

So yesterday I went up to Boston to talk to the good people at Dana-Farber about a promising new trial that may or may not help me.  It sounds good to me -- I'm all about science, future generations of patients, and hanging my hopes on the work of such very smart people.  I joined the queue for the trial and may start in six to eight weeks, if everything comes together.

This would involve some time in Boston.  But I understand that the local American League franchise there has a notable stadium and fans who are at least as civilized as those in Philly.  I've never been to Fenway, and I will certainly see if I can schedule my latest innovative therapy -- or hopeful roll of the dice, depending on how you look at it -- when the Royals are in town.