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Results for “Helsinki Declaration”

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PubMed1983

Legal requirements for drug testing in children in Germany.

Since 1966 the problem of evaluation of drugs for use in man has increasingly become the subject of both international and national consideration. It was generally felt, that there is a need for a special protection for children being the subjects of the clinical evaluation of drugs. A new impulse with regard to the protection of children was recently set by the Council for International Organizations of Medical Sciences. German legislation has included these international convictions and recommendations pertaining to the performance of clinical trials. Articles 40 and 41 of the German Drug Law of 1976 are an emanation of WHO principles as well as of the Declaration of Helsinki. These articles include special provisions for the protection of children as volunteers of clinical trials, because clinical trials in children are indispensable for research on diseases of children. It is laid down in the Law that children should never be subject of research that might equally well be carried out on adults. The willing cooperation and, as far as feasible, consent of the child and its custodians has to be sought. The German Law provides that trials in healthy children may take place only with regard to diagnostic and prophylactic drugs, not with regard to the therapeutics. Article 41 of the German Drug Law permits the clinical evaluation of drugs in ill children. Therapeutic drugs may, however, be tested in children only under the condition that the drug is determined to cure the special disease under which the child is suffering. Special aspects of the clinical evaluation of drugs in children, not contained in the law, need further discussion and clarification.

Adolescent↗
PubMed1982

Flunisolide nasal spray compared to beclomethasone dipropionate in the treatment of seasonal rhinitis.

Forty-seven informed out-patients with the diagnosis seasonal rhinitis of at least two years' duration took part in a controlled single blind, double observer, parallel four-center study for the purpose to compare efficacy and tolerance of two local corticosteroid nasal sprays: flunisolide 25 micrograms/dose and beclomethasone 50 micrograms/dose. The patients received for four weeks one of the two treatments; flunisolide 50 micrograms in each nostril twice daily or beclomethasone dipropionate 50 micrograms in each nostril four times daily. The study was conducted under the Declaration of Helsinki. Patients were assessed on admission and after two and four weeks. All patients completed the trial. The results showed that both drugs are highly effective in controlling nasal rhinitis symptoms, 21 out of 24 flunisolide treated patients and 21 out of 23 beclomethasone treated stated good to total control after four weeks' treatment during the pollen season. No statistical difference between the two could be discovered in any of the parameters measured. The only side effect recorded was mild transistory stinging in connection with application of the two different sprays. This occurred in a few patients in both groups. The results from the study indicate that the new corticosteroid flunisolide in a dose of 100 micrograms X 2 is comparable to beclomethasone dipropionate 100 micrograms X 4 concerning efficacy and tolerance in prophylactic treatment of seasonal rhinitis.

Administration, Topical↗