The Logistics of Clinical Trials

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Memorial Sloan Kettering experts discuss basic logistical information about how clinical trials work.

Paul Sabbatini, Deputy Physician-in-Chief for Clinical Research, discusses the three traditional phases of clinical trials. Phase 1 clinical trials establish the dose of the agent being tested and the medication schedule. Phase 2 trials examine whether the drug had the desired activity and generally consists of a small group of patients. If the desired activity is seen, the trial may move to Phase 3, which involves a much larger group of patients.

Medical oncologist David Hyman talks briefly about the logistics of clinical trials. He says there are a couple of key steps in patient participation. The first is that a doctor a given trial as a viable option for a patient. Then the patient must consent to participation in the trial. There are two steps to this process. One is a written document that outlines what care would consist of as part of the trial. It also covers risks, benefits, costs, and privacy issues. As part of the consent process, patients will have in-person conversations with their doctor, nurse, or others to make sure they fully understand what would happen during the trial. Once consent is given, medical testing is done to determine patient eligibility and if the trial is appropriate and safe for the patient. If the criteria are met, the patient can participate in the clinical trial.

Clinical nurse specialist Amy Copeland talks about the care that the patient can expect while participating in a clinical trial. She says it is very important to make sure all of the patient’s questions are answered up front, before treatment begins. Throughout the treatment period she sees patients during follow-up visits to discuss their side effects and general well-being as well as to address any questions the patient might have.