There is a useful overview of pharmaceutical drug development by Dr. Margaret Clotworthy, Chair
of the Human Tissues Working Party. In part of here feature, Dr. Clotworthy focuses
on new drug development and the lack of success that many companies have in bringing
new drugs to market. Dr. Clotworthy states:
"The FDA reports that 92% of all potential new drugs fail to make it to market, despite passing
preclinical toxicity tests en route to acceptance for clinical trials.2 The reasons for failure are
chiefly safety & efficacy, and it is safety which is the first requirement and of paramount importance.
The success rate for anti-cancer agents drops even farther to only 5% of all new drugs trialled3, despite the fact
that the bar for unacceptable side effects is naturally set rather lower for diseases such
as cancer which are life-threatening or seriously compromise quality of life.
This extraordinarily high failure rate must be addressed.
It contributes significantly to the burden of disappointed hopes, time, wasted opportunities
and unnecessary side effects borne by hopeful clinical trial participants, to say nothing
of the high development costs which are ultimately borne by national health providers such a
s the UK National Health Service (NHS) or through prohibitively high insurance premiums."
To read the full feature, on the Science Advisory Board page visit: Human-Focused Testing to Treat Human Diseases
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