Should Your Child Be in a Clinical Trial?
Withdrawing From a Clinical Trial
Parents can take their child out of a clinical trial at any time, and may want to if the treatment is not working for their child or if the side effects are intolerable. Before withdrawing a child from a trial, you should:
- Talk to the child's pediatrician, who can help you evaluate the consequences of leaving the trial.
- Ask the trial doctors if it is safe to leave. Some drugs should be tapered, so you should not just stop giving your child a drug.
- Let any other doctors the child sees know that the child is leaving the trial, in case he or she needs another medication in place of the one received in the study.
After withdrawing a child from a trial, parents should report to any new doctors who see the child, even years later, that the child was in a clinical trial and may have received a certain treatment.
FDA Encourages Studies in Children
FDA has taken a carrot-and-stick approach to encourage studies in children, says Rodriguez. The "carrot" is the Pediatric Exclusivity Provision of the FDA Modernization Act, passed initially in 1997 and becoming law under the Best Pharmaceuticals for Children Act (BPCA) in 2002. BPCA gives drug manufacturers a voluntary incentive of an additional six months of marketing exclusivity-the ability to sell their drug without competition from generic drugs-if they conduct pediatric studies of drugs that FDA determines may be useful to children.
The "stick" has been the Pediatric Rule, finalized in 1998 and basically passed as the Pediatric Research Equity Act (PREA) in 2003. PREA authorizes FDA to require manufacturers of new drug and biologics products to conduct pediatric studies in certain circumstances.
Together these two acts have encouraged the development of important new information for drugs used in children.
As of February 20, 2009, labeling changes have been made to over 260 products that were studied in children under BPCA or PREA. Of the more than 170 drugs studied just under the exclusivity incentive program within the BPCA, 159 have new pediatric labeling information including:
- 45 drugs with new or enhanced pediatric safety data that hadn't been known before
- 27 drugs with new dosing or dosing changes
- 50 drugs with information stating that they were not found to be effective in children
"This means that before these drugs were studied in children, we were giving children the wrong dose for at least some part of the pediatric populations for one-sixth of these drugs," says Murphy. "In addition, we found that one-third of them didn't work in children and one-fourth of them raised a new pediatric safety issue."
One of the safety issues that arose during the studies was concerns with suicidal thinking for antidepressants called selective serotonin reuptake inhibitors (SSRIs). These antidepressants now carry a black box warning-FDA's strongest warning-on their labeling about increased risk of suicidal thinking and behavior in children, adolescents, and young adults. The warning does not mean that the product shouldn't be used if a depressed child needs treatment, but it gives parents, caretakers, and physicians signs to monitor when beginning or changing the treatment.