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May 22, 2005
That Has to Be Good, Right?
Here's a nice article over at Forbes which highlights a tough question: what's the best indicator of efficacy for a new cancer drug? One of the easiest things to measure is tumor shrinkage, and you'd think that would be a good sign. Common sense can only take you so far, though:
"But now doctors are finding that tumor shrinkage, on its own, isn't necessarily a good reason to use a drug, because it's entirely possible to shrink a tumor without helping the patient. More important measures of efficacy are how long it takes for the cancer to start worsening and how long patients live. If a drug increases survival time, its efficacy clearly outweighs any side effects."
Survival, of course, takes a lot longer to measure, and time is nowhere more equivalent to money than in a clinical trial. If we're going to start moving away from the classic response rate - number of patients with 30% or more shrinkage - then we're going to be spending a lot more to evaluate our drugs. It's true that the article linked above quotes someone who doesn't buy this logic, but he's talking about using some genetic marker as a surrogate. This is a very nice idea, but we're back to the same problem: it also takes years to prove that these things are linked to survival, and that'll always be the real standard. Who cares what your cancer is up to if it kills you on the same schedule?
No, using survival as the endpoint will almost always cost more. But I think it'll be worth it. I've never understood the benefit to desperate patients of giving them something that's just going to make them spend their last months being jerked around.
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