Medication development and testing in children and adolescents : Current problems, future directions.
Progress in pediatric psychopharmacological research has suffered notable delay, especially compared with the achievements in adult psychopharmacology.
Although safety and efficacy of the use of many psychotropic agents in children remain largely unproved, their pediatric use has been increasing and their widespread off-label prescribing by practitioners has raised some important concerns.
The National Institute of Mental Health, in cooperation with the Food and Drug Administration and leading researchers, has coordinated systematic efforts to identify the major obstacles to research in pediatric psychopharmacology and to propose feasible solutions.
In 1995, a conference cosponsored by the National Institute of Mental Health and the Food and Drug Administration gathered more than 100 research experts, family and patient advocates, and representatives of mental health professional associations.
Participants met in working groups focused on specific aspects of child research and reached consensus on various recommendations.
Each of the various aspects relevant to conducting research in this area (methodological, ethical, legal, regulatory, financial, and family or community context) presents specific challenges, which are herein outlined.
Recommendations for possible solutions are presented, some of which are being implemented. (...)
Mots-clés Pascal : Psychopharmacologie, Recherche développement, Essai clinique, Enfant, Homme, Adolescent, Chimiothérapie, Efficacité traitement, Toxicité, Ethique, Analyse économique
Mots-clés Pascal anglais : Psychopharmacology, Research and development, Clinical trial, Child, Human, Adolescent, Chemotherapy, Treatment efficiency, Toxicity, Ethics, Economic analysis
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0486944
Code Inist : 002B02B11. Création : 03/02/1998.