Pros and cons of clinical trials

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Making the decision whether to have your child participate in a clinical trial is sometimes difficult. The following lists of reasons why some families chose to enroll or not may help you clarify how you feel about this important decision.

Why some families choose to enroll:

• Children receive either state-of-the-art investigational therapy or the best standard therapy available.

• Clinical trials can provide an opportunity to benefit from a new therapy before it is generally available.

• Information gained from clinical trials will benefit children with cancer in the future.

• Children enrolled in clinical trials may be monitored more frequently throughout treatment. Information gathered across the country is available to benefit enrolled children earlier than those not enrolled in studies.

• Review boards of scientists oversee the operation of clinical trials.

• Participating in a clinical trial often makes parents feel that they did everything medically possible for their child.

• Phase I and II studies provide free drugs, and some aspects of monitoring may be supported.

Reasons why families choose not to enroll:

• The experimental arm may not provide treatment as effective as the standard, or it may generate unexpected side effects or risks.

• Some families do not like the feeling of not having control over choosing the child's treatment.

• Some clinical trials require more hospitalizations, treatments, clinic visits, or tests that may be more costly or painful than the standard treatment.

• Some families feel additional stress about which arm is the best treatment for their individual child.

• Insurance may not cover investigational studies. Parents need to carefully explore this issue prior to signing the consent form.

When we were struggling with the decision of whether to join the study, I asked the oncologist how would we ever know if we made the right decision. He said something very wise: "You will never know and you should never second-guess yourself, no matter how the study turns out. Statistics are about large groups of kids, not your child. Your child might relapse no matter which arm she is on, and she might be cured on an arm where most of the other kids relapse. Statistics for you will be either one hundred percent or zero because your child will either live or die. I can't tell you which will be the better treatment; that is why we are conducting the study. But no matter what, we will be doing absolutely the best we can."

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