Feb 19

Inclusion of women and children in clinical research trials

Clinical trials (or clinical research trials) look at the response of human to a new drug or therapy. However, because of the vulnerability of some groups of people, if targeting on those groups, some studies have to be redesigned to consider the special needs of those people. Hence, those groups may need special considerations regarding the risks and benefits of the new drug/therapy, and the dosage or scheduling may need to be readjusted compared to the general adult use.

(a) Inclusion of Pregnant Women in Clinical Trials
Because of the possiblity of the investigational compound being passed to the foetus, clinical research trials involving pregnant women need special attention. Generally, pregnant women are excluded from clinical trials, unless the medicinal product is intended for use during pregnancy. Importantly, if a patient/volunteer become pregnant during the treatment phase of the clinical trial study (after the first dose of study medication/therapy was administered), the patient or volunteer is usually discontinued from the study, if this can be done in a safe way. The pregnancy of any women who become pregnant during a clinical trial study have to be followed up, even after the birth of the child. Indeed, the evaluation of the pregnancy, but also of the foetus and child is very important, to make sure that the compound, not only has no side effects on the mother, but also on the pregnancy, the foetus and the born child.

If a woman becomes pregnant during a clinical trial, she will normally be taken off the study and closely followed throughout her pregnancy.

(b) Inclusion of Nursing or lactating women in Clinical trials
Several medicinal products can be excreted in the milk of a lactating woman. This is why it is important to examine excretion of the drugs or its products in the milk of lactating women enrolled in a clinical research trial. This assures that there is no excretion or a safe level of excretion of the investigational drug in the milk of the lactating mother. If applicable, babies from lactating and nursing women enrolled in clinical research trials are closely monitored for the effects of the therapeutic drug.

Drugs or their metabolites can be excreted in the milk of the mother.

(c) Inclusion of Children in Clinical Trials
Children are much smaller and vulnerable than adults. This is why clinical research trials carried on children have to be redesigned and have to consider the child`s size and physiology. The decision to include children in a clinical trial will depend highly of what is known about the investigational drug and the possibility of extrapoling data and results from adults and children of other age groups. Also, some drug may be used in children from the early stages of drug development.
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Kids are more vulnerable, therefore clinical trials targeting kids have to consider their special needs

Hence, although children, pregnant women and nursing women are usually excluded from clinical trials, if enough data is gathered from other clinical research trials, new studies can be redesigned to suit those groups challenges. However, adults that are not at risk of becoming pregnant are usually a preferred group for primary safety data.


(1) ICH E6
(2) ICH M3
(3) Health Canada
(4) FDA

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