Carol Hahn, MD, Medical Director of Radiation Oncology at Duke Raleigh Cancer Center.
Joseph Moore, MD, Medical Director of Duke Raleigh Cancer Center.
These miraculous stem cells can also come from umbilical cord blood. Dr. Moore said more and more parents have been saving their newborns’ cord blood and making it available through blood banks. These cells must be harvested at birth, so potential donors should discuss the option with their obstetricians. Duke maintains the Carolinas Cord Blood Bank that’s been providing life-saving cord blood cells to unrelated, but matched, donors since 1998. This cord blood can be made available to patients who need it through a donor match program. Dr. Moore said there’s a one-in-four chance a sibling’s blood would be a match for a brother or sister who needed it. There’s a one-in-100,000 chance that a potential recipient would be a match with an unrelated donor. Yet, it does happen. Being part of the solution Being part of a clinical trial can come with risks. Those risks are explained in detail to the patient so he or she can weigh all options and give his or her informed consent. “Not everyone will be a candidate for a clinical trial,” said Seastrunk. “There is a screening process to determine if a patient would be appropriate for a given trial.” Dr. Moore said each clinical trial has its own unique criteria for inclusion. Once patients have volunteered to be part of a trial and it’s under way, they are monitored extremely closely. In fact, before a trial ever gets to the phase where patients have the option to participate, it’s gone through an incredible amount of rigorous testing. Seastrunk explains how a trial for a new drug works: “Most clinical trials start off in a laboratory phase where the research begins. Physicians will then develop protocols around length of time of treatment, [criteria for selecting patients, and so on.] Once all the initial research and protocols have been completed, it will go to the FDA for review before it can begin to be rolled out in practice.” “Once rolled out, it can go through four phases,” Seastrunk continues. “Phase 1 trials are generally done on a small sample of patients to refine the delivery process of the new drug and focus on the safety and side effects. Phase 2 involves more patients – sometimes several hundred – and this phase can last for a couple of years. Phase 3 trials are then expanded to even more patients. This phase involves randomizing which patients will receive the new treatment and which ones will not, so at the end, they can compare the two groups to see if 104 | midtownmag.com
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