A Textbook of Clinical Pharmacology and Therapeutics

ETHICS COMMITTEES
Protocols for all clinical trials must be reviewed and approved
by a properly constituted independent ethics committee.
Research Ethics Committees are coordinated by NRES
(National Research Ethics Services) working on behalf of the
Department of Health in the UK.
NRES maintains a UK-wide system of ethical review that
protects the safety, dignity and well-being of research participants
whilst facilitating and promoting research within the
NHS.
Interestingly, studies have shown that patients taking part
in clinical trials often have better health outcomes than those
not involved in a trial.
GLOBALIZATION
In order to facilitate world-wide drug development and
encourage good standards of practice, a series of international
conferences on harmonization of requirements for registration
of pharmaceuticals for human use have been conducted.
International Conferences on Harmonisation (ICH) are leading
to a globally accepted system of drug development,
hopefully without stifling research with excessive bureaucracy
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GLOBALIZATION 91
and without any lowering of standards. The goal is to facilitate
the early introduction of valuable new therapies, while at
the same time maximizing patient protection.
Case history
Rather than a clinical case history, consider a chapter in the
history of drug regulation which is instructive in illustrating
the value of toxicity testing. Triparanol is a drug that
lowers the concentration of cholesterol in plasma. It was
marketed in the USA in 1959. In 1962, the Food and Drug
Administration (FDA) received a tip-off and undertook an
unannounced inspection. This revealed that toxicology
data demonstrating cataract formation in rats and dogs
had been falsified. Triparanol was withdrawn, but some of
the patients who had been taking it for a year or longer
also developed cataracts.
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