European regulatory authorities and pediatric labeling.

Ethical Considerations Children should not be given medicines that have not been evaluated adequately for use in that age group. There is a responsibility, shared by applicants and the appropriate authorities, to ensure that children have timely access to safe and effective medicines that have accurate, scientifically justified prescribing information. Applicants are encouraged to investigate the safety and efficacy of a product in children, if it is likely to be of therapeutic benefit in this age-group, and to develop suitable formulation, even if use is likely to be small. However important a clinical trial may be to prove or disprove the value of a treatment, individual members of one or both of the groups—subject or control—can suffer injury as a result of inclusion in the trial, even if the whole community benefits. As with adults who participate in clinical trials and who understand the issues involved in giving their informed consent, consent should be obtained from the legal guardian of children in accordance with national legislation. Children should be fully informed about the trial in language and terms they understand and, if able, should personally sign and date the written informed consent. The child should be made aware of his/her rights to decline to participate. The child’s wish to be withdrawn from a study must be respected. These measures should be applied in conjunction with 1) part 4 of Directive 75/318/EEC, as amended, which requires “. . . details concerning patients who may be at increased risk”; the CPMP/ICH guideline for good clinical practice; and 3) the CPMP guideline on biostatistical methodology in clinical trials in applications for marketing authorizations for medicinal products. These measures are intended to assist applicants with specific problems presented by medicinal product testing in children. The child should stand to obtain some direct benefit from the clinical trial, except under very specific conditions, although it is not appropriate to offer financial or other inducements to parents, guardians, or children to participate in clinical trials. However, they may receive reimbursement for their costs, including those for travel and subsistence.