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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