Recently, I've pointed out the clashes between business and ethical considerations and beween clinicians' obligations to their individual patients and to the method that leads to advances. What if researchers can find ways to satisfy both the science and today's patients?
Wall Street Journalist Ron Winslow wrote A New Rx for Medicine. He introduces us to Dr. Laura Esserman, director of the breast-care center at UCSF and co-leader of a trial called I-Spy 2, which uses a new approach to clinical trials: Adaptive Design."
Dr.Esserman explains that using the latest advances in genetics and the molecular makeup of individual tumors can steer researchers to the most effective agents against specific tumors.
- Patients will be treated only after their tumors are shown to have a high probabiity of responding to the investigational drug.
- Researchers will look at data right away (instead of waiting until the study is over to "unblind" the researchers); analyses done as the study progresses can guide the therapies used in subsequent trial subjects.
- Surgery is performed after the investigational chemotherapy (instead of before), which means response can be assessed at the end of treatment (how much did the tumors shrink compared to their size on MRI at diagnosis?) instead of waiting - often years - for recurrences.
Adaptive Design is not a slam dunk. Although biomarkers are helpful predictors of a drug's effectiveness, they are not perfect. Given the complexity of cancer, it's not surprising that tumors with the same biomarkers can respond differently to the same investigational treatment.
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