Children clinical trials

In phase I clinical trials children with recurrent or refractory tumors previously treated with free doxorubicin were administered i.v. Doxil in various doses (40-70mg/m2) in order to determine the best tolerated one [391], It was concluded that the maximum tolerated dose was 60mg/m2 because at the highest, 70mg/m2, some patients developed mucositis, so dose adjustment was necessary. 

The SAS code you wrote would eliminate the observation for subjectid=102. This is because the aeyn field is not populated for that row and is therefore eliminated by the WHERE clause in SAS. This is a classic parent-child data problem in clinical trial data, where the parent question is left unanswered but the child response is given. A way to handle this problem would be either to include the aetext field in the WHERE clause or to add a warning to the SAS log. The code in Program 1.4 does both. 

Children s Diagnostic Classification. Children s Diagnostic Classification (CDC) test may be used instead of the Children s Psychiatric Rating Scale (CPRS) to arrive at a diagnosis. This differs from the CPRS in that it is highly directed and leads the observer to a diagnosis. It rates the current status of the child and may be used at pretreatment and/or the termination of the clinical trial. 

The Committee had required as a minimum, teratogenicity testing in two species, one of which should preferably be a non-rodent, for one generation only. They also recognised the limitations of teratogenicity tests in animals but emphasised that only in the most exceptional circumstances would they release any drug for clinical trial in women of child-bearing age rmtil the appropriate tests on animals had been carried out satisfactorily. 

Franklin, M.E., Kozak, M.J., Cashman, L.A., Coles, M.E., Rhein-gold, A.A., and Foa, E.B. (1998) Cognitive-behavioral treatment of pediatric obsessive-compulsive disorder an open clinical trial. / Am Acad Child Adolesc Psychiatry 37 412—419. 

Malhotra, S. and Santosh, P.J. (1998) An open clinical trial of Buspirone in children with attention deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry 37 364-371. 

Brent, D.A., Kolko, D., Birmaher, B., Baugher, M., and Bridge, J. (1999b) A clinical trial for adolescent depression predictors of additional treatment in the acute and follow-up phases of the trial. / Am Acad Child Adolesc Psychiatry 38 263-270. 

Geller, D.A., Hoog, S.L., Heiligenstein, J.H. (2001) Fluoxetine treatment for obsessive-compulsive disorder in children and adolescents a placebo-controlled clinical trial. / Am Acad Child Adolesc Psychiatry 40 773—779. 

Ghazuiddin, N. and Alessi, N.E. (1992) An open clinical trial of trazodone in aggressive children. / Child Adolesc Psychopharmacol 2 291-298. 

Mounting a clinical trial in child psychopharmacology requires the integration of considerable clinical and research expertise. Attention must be paid to multiple design and methodological aspects, and scientific goals... 

Biton V, Levisohn P, Hoyler S, Vuong A, Hammer AE. Lamotrigine versus valproate monotherapy-associated weight change in adolescents with epilepsy results from a post hoc analysis of a randomized, double-blind clinical trial. J Child Neurol 2003 18 133-9. 

An urgent meeting of the Group was convened on 4 June 2003 to consider clinical trial data which had just been received by the MHRA on the safety of paroxetine in the treatment of major depressive disorder in children and adolescents. Child and adolescent psychiatrists were invited to join the Group as visiting experts for the discussion of the data. The advice of the group informed CSM s announcement on 10 June, that paroxetine was contraindicated in patients under the age of 18 with major depressive disorder. 

Emslie, G., Heiligenstein, J., Wagner, K., Hoog, S., Ernest, E., Brown, E., et al. (2002). Fluoxetine for acute treatment of depression in children and adolescents A placebo-controlled randomized clinical trial. Journal of the American Academy of Child and Adolescent Psychiatry, 41, 1205—1215. 

MELD/PELD/Child-Pugh scores are not designed to provide information on likely drug handling in a patient, but they are often used as surrogate markers in clinical trials. If available, they may give an indication of how far advanced the liver disease is overall. 

Emesis has been used for children and also for adults who refuse activated charcoal or gastric lavage, or if the poison is not absorbed by activated charcoal. Its routine use in emergency departments has been abandoned, as there is no clinical trial evidence that the procedure improves outcome for poisoned patients. Emesis is induced, in fully conscious patients only, by Ipecacuanha Emetic Mixture, Pediatric (BNF), 10 ml for a child 6-18 months, 15 ml for an older child and 30 ml for an adult, i.e. all ages may receive the same preparation but in a different dose, which is followed by a tumblerful of water (250 ml). The active constituent of ipecacuanha is emetine it can cause prolonged vomiting, diarrhoea and drowsiness that may be confused with effects of the ingested poison. Even... 

For children, most ethics committees agree that provision of written informed consent by a parent or guardian is acceptable. If the childis of sufficient age, then his or her concurrence may also be sought although this is not sufficient evidence of informed consent, the refusal to provide concurrence by a child that is likely to be competent to understand the clinical trial conditions should be sufficient to exclude the child from a study. 

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