| Show 2002 more than 8 million Americans volunteered to test new experimental drugs and medical procedures Here's what you should know In BY DENISE GOODMAN “WHEN YOU’RE POKING YOURSELF FOUR Hmw a day this sounded very good" says Lany Willis a diabetic who had been injecting himself with insulin for 12 years His physician had suggested that he volunteer for a drug trial for inhaled insulin Neariy two yean into the research project die carpentorfiomfonfaroke Pines FIl levels have stabilized He feels says his blood-sugmuch better and be figures that accepting a “guinea pig" rote wifi benefit millions of other diabetics Every prescription drug from Vioxx to Viagra has been subjected to clinical trials before receiving approval from the Food and Drug Administration (FDA) Last year an estimated 83 million Americans participated in some 8(MX)0 clinical trials to assess the safety and effectiveness of experimental drugs and medical procedures 55-ye- ar ar Inorderfbratrial to be compliant with federal guidelines an Institutional Review Board (IRB) must be prcsenLThis is a panelof physicians and scientists assembled by the National Institutes of Health or by the phannaceutical company or university conducting the research It formulates criteria and trial procedures then monitors trial implementation and review These boards are mandated by the FDA which oversees clinical trials and by the US Depart-meof Health and Human Services which oversees trials In both cases the IRB can d government-sponsorehalt a study when trial protocols are not followed or when significant adverse reactions occur indu- nt stry-sponsored MMK MUCH tOOS MIMM MMAflNi |
