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<p>The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests
considered that the key limitations of previous studies related to the accuracy of
recording of what drug was taken by the women; clarity over the timing of administration
during pregnancy; adjustment for confounding factors; selection of controls; and the
statistical methodology.</p><p> </p><p>The Expert Group used a quality scoring system
to evaluate the quality of each individual study according to a set of seven pre-defined
quality criteria. The criteria and score agreed by the Expert Working Group for each
study are published in Annex 27 of the final report.</p><p> </p><p>The criteria for
selecting members of the Expert Working Group were based on the expertise needed to
evaluate all aspects of the questions before the Group and the types of data that
would need to be assessed. Membership included those with expertise in pharmaco-epidemiology,
including perinatal and paediatric epidemiology, medical statistics, embryology, clinical
genetics, gynaecology, reproductive endocrinology, toxicology and pharmacology.</p><p>
</p><p>The process for selecting members was in line with established policy for expert
groups of the Commission on Human Medicines, with the nominations being agreed by
the Commission and endorsed by Ministers.</p>
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