CLINICAL TESTING
OF DRUGS
Experiments conducted on
animals are essential to the development of new chemicals for the management of
disease. The safety and efficacy of new drugs, however, can be established only
by adequate and well-controlled studies on human subjects. Since findings in
animals do not always accurately predict the human response to drugs, subjects
who participate in clinical trials are put at some degree of risk. The risk
comes not only from the potential toxicity of the new drug but also from
possible lack of efficacy, with the result that the condition under treatment
becomes worse. Since risk is involved, the pri-mary consideration in any
clinical trial should be the welfare of the subject. As a consequence of
unethical or questionably ethical practices committed in the past, most
countries have established safeguards to protect the rights and welfare of
persons who participate in clinical trials. Two of the safeguards that have
been es-tablished are the institutional
review board (IRB) and the requirement for informed consent.
The IRB, also known as the
ethics committee or hu-man subjects committee, originally was established to
protect people confined to hospitals, mental institutions, nursing homes, and
prisons who may be used as subjects in clinical research. In the United States
any institution conducting clinical studies supported by federal funds is
required to have proposed studies reviewed and ap-proved by an IRB.
People who volunteer to be
subjects in a drug study have a right to know what can and will happen to them
if they participate (informed consent). The investigator is responsible for
ensuring that each subject receives a full explanation, in easily understood
terms, of the pur-pose of the study, the procedures to be employed, the nature
of the substances being tested, and the potential risks, benefits, and
discomforts.
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