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Dictionary of Evidence-based Medicine.pdf

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C<br />

CANDA<br />

CANDA is the abbreviation used for computer-assisted new drug application,<br />

a procedure which was introduced by the FDA recently (see Prescription<br />

Drug User Fee Act 1992) to speed up the review process <strong>of</strong> licensing<br />

<strong>of</strong> new drugs.<br />

Carstairs score (see under Cluster sampling)<br />

Case-control study<br />

In the study <strong>of</strong> rare events, for example rare adverse drug reactions, it is<br />

usually not possible to mount a controlled study to investigate causation.<br />

Impossibly large numbers <strong>of</strong> subjects would have to be recruited and studied<br />

under controlled conditions. Under such circumstances observational<br />

studies are used. One <strong>of</strong> the most powerful designs for such studies, albeit<br />

not ideal because <strong>of</strong> the poor control investigators have over confounding<br />

factors, is the case-control design. Cases or subjects with the event <strong>of</strong> interest<br />

(e.g. women <strong>of</strong> childbearing age and with a stroke) are recruited along<br />

with matched control subjects without the event and their history <strong>of</strong> exposures<br />

to various putative risk and confounding factors detailed to identify<br />

any significant associations.<br />

Case-control studies are normally classified as retrospective studies in<br />

that subjects with a particular event (e.g. a stroke) are identified and<br />

their history <strong>of</strong> exposure to various putative risk factors established retrospectively<br />

and compared with that <strong>of</strong> control subjects. Case-control studies<br />

leading to the establishment <strong>of</strong> a link between phaecomelia in newborns<br />

and ingestion <strong>of</strong> thalidomide by their mothers is an example. The cases were<br />

already known and the drug history <strong>of</strong> their mothers and that <strong>of</strong> control<br />

mothers followed retrospectively. It would clearly not have been ethical<br />

to undertake a controlled study to establish the causal association. The<br />

adverse effect was not previously seen and was disastrous. In other types<br />

<strong>of</strong> adverse effects, for example pulmonary hypertension, case ascertainment<br />

may be difficult and a prospective case-control study may then be

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