Lecture 9 Understanding Clinical Trials Clinical trials They are a research study in human volunteers to answer specific health questions Fastest and safest way to find treatments that work in people and ways to improve health Types of clinical treatments Treatment test new treatment approaches ex adjust change dose Prevention prevent disease in na ve people or prevent disease recurrence Screening test methods of find disease Diagnostic find better diagnosis methods determine presence absence of disease Quality of life improve comfort quality of life Compassionate use provide partially tested unapproved therapeutics to a small of patients who have no other realistic options FDA regulated Used in unresponsive patients Clinical trial design standard treatment Randomized subjects are randomly assigned to receive either the study treatment or Blind subjects do not know which treatment they receive Double blind researchers also do not know Placebo controlled the use of a placebo fake treatment allows the researchers to isolate the effect of the study treatment from the placebo effect Randomized trials Participants have equal chance to be assigned to one of two or more groups One gets the most widely accepted treatment standard treatment The others get the new treatment being tested which researchers hope to believe will be better than standard treatment Protection for participating in clinical trials Government has strict guidelines to protect participants Must be approved and monitored by an Institutional Review Board IRB An IRB is an independent committee of medical specialists nurses etc who review clinical trial protocols at institutions that conduct medical research Informed consent must be obtained before participation approved Benefits of participation Patients will receive at minimum the best standard treatment If new treatment works patients may be among the first to benefit Patients have a chance to help others and improve cancer care Risks of participation New treatments interventions are not always better than standard care Even if a new treatment has benefits it may not work for every patient Health insurance do not always cover clinical trials Why do so few people participate Doctors might Lack awareness of appropriate clinical trials Be unwilling to lose control of a person s care Believe that standard therapy is best Be concerned that clinical trials add administrative burdens Sometimes patients Don t know about them Don t have access to trials May be afraid suspicious of research May not want to go against physician s wishes Can t afford it
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