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The European Commission is currently seeking comments on a draft report into the ethics of clinical trials involving children. Ethical Considerations for Clinical Trials Performed in Children has been prepared by an Ad-Hoc committee looking into developing and implementing guidelines for the Clinical Trials Directive (2001/20/EC) related to good clinical practice in the conduct of clinical trials on medicinal products for human use. The authors of the Clinical Trials Directive recognised a need for investigations involving children, as they are physically and developmentally different than adults. However, as they are a vulnerable population, special issues will arise. “Medicinal products, including vaccines, for children need to be tested scientifically before widespread use.…The clinical trials required for this purpose should be carried out under conditions affording the best possible protection for the subjects. Criteria for the protection of children in clinical trials therefore need to be laid down.”

 

Broad topics covered include: informed consent; assent from the child; the need for appropriate expertise on ethics committee to review paediatric clinical trials; trial designs; pain, distress and fear minimisation for children involved in trials; and measures of benefit whether directly for the child or those with the same disease or condition. Specific guidance is given on, for example, informed consent (and assent from children) for emergency trials, informed consent (and assent for children) of families from a different cultural background, and differences of opinion between the child and the legal representative. The final recommendations, resulting from this consultation, should be of benefit to ethics committee members, sponsors and investigators who are involved with paediatric clinical trials. The consultation ends 31 January 2007; comments can be sent to entr-pharmaceuticals@ec.europa.eu.