E-drug: Ethics of clinical trials (cont'd)
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Dear Dr Batolar,
The following is an extract from ICH Harmonised Tripartite Guideline,
General Considerations for Clinical Trials, E8. The full text can be
found at www.ich.org . Go to ICH Guidelines, then Efficacy Topics. I
hope this helps. More targeted advice on development of
antimalarials could be discussed, and studies in pregnant women and
children can be included, based on more information.
Peter A. S. Motteram
Partner
Opttimus Consulting
Tel: +44 (20) 8645 0599
E-mail: peterm@opttimus.com
www.opttimus.com
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"Particular attention should be paid to the ethical considerations
related to informed consent from vulnerable populations and the
procedures scrupulously followed (see ICH E6).
a) Investigations in pregnant women
In general, pregnant women should be excluded from clinical trials
where the drug is not intended for use in pregnancy. If a patient
becomes pregnant during administration of the drug, treatment
should generally be discontinued if this can be done safely. Follow-up
evaluation of the pregnancy, foetus, and child is very important .
Similarly, for clinical trials that include pregnant women because the
medicinal product is intended for use during pregnancy, follow-up of
the pregnancy, foetus, and child is very important.
b) Investigations in nursing women
Excretion of the drug or its metabolites into human milk should be
examined where applicable. When nursing mothers are enrolled in
clinical studies their babies should be monitored for the effects of the
drug.
c) Investigations in children
The extent of the studies needed depends on the current knowledge
of the drug and the possibility of extrapolation from adults and
children of other age groups. Some drugs may be used in children
from the early stages of drug development (see ICH M3). For a drug
expected to be used in children, evaluation should be made in the
appropriate age group. When clinical development is to include
studies in children, it is usually appropriate to begin with older children
before extending the trial to younger children and then infants."
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