How does patient risk and benefit evolve over the research life-cycle of a cancer drug? Jonathan Kimmelman and his team at STREAM Research asked this question about the tyrosine kinase inhibitor, sunitinib. The graph below depicts what they found: As the research program evolved over 10+ years and 100+ trials in dozens of different cancer indications, the risk/benefit profile for patients got steadily worse.
What does this show?
This graph illustrates just how dense a drug development program can be, and in so doing, it helps to sharpen some questions about patient safety over the course of a research program. The indications where sunitinib is beneficial were identified quite early on in the program. This was followed by a wide exploration of many other indications, for the majority of which, sunitinib was not found to be beneficial. It thus seems like a patient considering enrolling in a sunitinib trial (or any drug trial) might therefore want to know where in the life-cycle is the experimental intervention. Is it early on, when the developers or pursuing the most promising signals of efficacy? Or is it later on, when the clinical utility may have already been exhausted?