On January 4, 2002, President Bush signed the Best Pharmaceuticals for Children Act (BPCA) to establish a process for studying on-patent and off-patent drugs for use in pediatric populations, and to improve pediatric therapeutics through collaboration on scientific investigation, clinical study design, weight of evidence, and ethical and labeling issues. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) leads BPCA efforts on behalf of the National Institutes of Health (NIH), including the National Cancer Institute. NICHD's strengths in conducting safe and effective clinical trials in populations thought to be fragile, such as children and pregnant women, also made the Institute the natural choice to help spearhead BPCA efforts of NIH. The Eunice Kennedy Shriver NICHD and other NIH Institutes involved in the BPCA, including the National Cancer Institute are collaborating with the U.S. Food and Drug Administration (FDA) to design clinical trials for pediatric populations. Once a RFP is submitted, negotiated, and a contract awarded to the most-qualified group, the final protocol for the trial is developed, with guidance from NICHD and with input from and interaction with the appropriate NIH Institute or Center, including the National Cancer Institute, the BPCA Coordinating Center (CC), the Principal Investigator (PI), the FDA, and the Institutional Review Boards (IRB). The protocol becomes the blueprint for the trial and the basis of the Investigational New Drug (IND) submission to FDA. All researchers and staff involved with clinical trials follow every federal regulation and ethical guideline in conducting the study to ensure the safety of participants. Frequent evaluation by those involved and by independent entities throughout the course of the trial provides added safety.
