Tips For Parents Who Want to Enroll Their Child in a Clinical Trial

ARLINGTON, Va. - October 24, 2001 - With the introduction of the FDA's Pediatric Exclusivity* provision in 1997, more parents have the option of enrolling their sick child into a clinical trial. The provision is helping to eliminate the guesswork surrounding the safety, proper dosing and efficacy of adult-approved medications prescribed to children. Often thousands of participants are required for a single clinical trial, but when the test subjects are their own children, parents are faced with weighing the risks versus the benefits of involving their own youngsters.

To help parents make the right decision for their child, the American Association of Pharmaceutical Scientists (AAPS) is issuing the following guidelines developed by pediatric experts attending its Annual Meeting this week in Denver, Colorado:

• Share your intensions about participating in a clinical trial with your child's pediatrician. He or she know your child's medical history and can help evaluate the risks and benefits associated with the program.
• Ask detailed questions about trial length and the expected time commitment. How many days of work and school will you and your child miss? Will you be compensated for your travel or time?
• Question who will be providing medical care to your child. You want a team that is specifically trained in pediatric care so they are sensitive to the special needs of sick children.
• Understand what signs and symptoms exhibited during the trial could indicate a problem.
• What criteria and/or "escape clauses" exist should you decide to resign your child from the trial?

For more information about pediatric trials and how to get involved in a clinical trial, go to clinicaltrials.gov (specializes in trials for life threatening or rare diseases), actis.org (AIDS specific), fda.gov/cder/pediatric , or contact your local children's hospital, an organization specializing in your child's condition or ask your pediatrician.

* Pediatric Exclusivity is a provision in the FDA Modernization Act (FDAMA) that encourages pharmaceutical companies to conduct clinical trials on medications often prescribed to children. Those that voluntarily participate receive a patent extension of six months on the product being tested.

About AAPS AAPS is a professional, scientific society of more than 11,000 members employed in academia, industry, government and other research institutes worldwide. Founded in 1986, AAPS aims to advance science through the open exchange of scientific knowledge, serve as an information resource, and contribute to human health through pharmaceutical research and development. For more information about AAPS, visit AAPS Pharmaceutica at www.aapspharmaceutica.com.

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