The U.S. Congress recognized this when it passed the FDA Modernization Act in November 1997, which encouraged clinical studies on pediatric patients during the drug development process. The FDA revised that rule in December 2000 to require pharmaceutical companies to conduct pediatric studies on any new adult drugs that can be used in children with the same disease. In addition, adult drugs that are already on the market and widely used in children must also undergo pediatric testing and labeling. Most participants receive a free physical examination and medication. Parents and children with chronic illnesses want to help in some way to improve care for their disease.
Parents often feel as if they receive more personalized care and education.
Many children would like to receive research medication before it is commercially available. The government has strict guidelines and safeguards to protect people who choose to participate in clinical trials. An IRB is an independent committee of physicians, statisticians, community advocates and others which ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research. Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate.