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Clinical Trials What Are They and When Are They Right For You? Maura N. Dickler Assistant Attending Physician Breast Cancer Medicine Service Memorial Sloan-Kettering Cancer Center What is a Clinical Trial? A study designed to answer a specific question • Drug development • New surgical technique • Psychosocial intervention • Long term side-effects of therapy What goes into designing a clinical trial? • Generate a hypothesis/ask a question • Design a trial to test that hypothesis • Involves a team of researchers including physicians from multiple disciplines and biostatisticians • Review by multiple committees – Scientific committees – Patient safety committees (Institutional Review Board or IRB) – FDA – National Cancer Institute (NCI) Types of Trials • Phase 1: tests dose, schedule, feasibility – Primary endpoint: side effects • Phase 2: tests whether the drug or combination works – Primary endpoint: effectiveness – All patients have the same disease • Phase 3: randomized trial – Primary endpoint: is one therapy better than the other Different Trial Designs • Open label • Blinded • Placebo-controlled Who is Eligible to Participate? • Inclusion criteria – Type of breast cancer (e.g. ER+, HER2+) – Measurable or non-measurable disease • Exclusion criteria – Pre-existing conditions – Baseline organ function (e.g. good blood counts, normal kidney function) Informed Consent • What is the informed consent? • Why is it necessary? • What information is provided? – Rationale of the trial – Who can participate – Risks/benefits – Side effects – What is covered by the trial vs. what will be billed to insurance When is a Trial Right for You? • Talk with your physician • Utilize resources available on the web – NCI website – Academic websites • Seek other opinions at academic centers • Talk with fellow patients/advocates • Be your own advocate, but you should not feel alone