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Microcap & Penny Stocks : Pharmos(PARS) -- Ignore unavailable to you. Want to Upgrade?

To: arnie h who wrote (1093)	7/26/1998 2:38:00 PM
From: Cacaito	Read Replies (2) \| Respond to of 1491

It is not necessary to unblind the data for pharmacokinetics studies, the blood of the patients in the study is collected and sent to the laboratory for blood levels of the drug in question. The ones who draw the blood do not know which patient is getting the drug. The sample is label with a code, and the laboratory technicians do not know who is the patient. Then the drug levels will tell you which sample has the drug and how much of it, but only when all the data is unblinded it is known to who it belongs. The kinetics of the drug, the way the drug is absorbed, change and eliminated by the body, could be study during the blind trial and in this way save money and time because one does not need another study, so this pharmacokinetics studies are run in parallel with the main study. The drug dosage change, as neuroinvestment suggested, was most probably fine tuning from the drug levels data. If the pharmacist is suspecting a flat level at certain dose, then to double it as initially planned it is redundant, the two doses will give for all practical purposes the same level, and presumably same results. It is prudent to do that, toxicity is more common at those levels, no need to exposed the patients. Regarding, "the earlier comments about the data" it was the "overall" numbers at the Pharmos website. This is the data for all the patients given drug or placebo, it is always known due to the need for safety. They reported lower mortality when compared to "historical" data meaning the numbers about the disorder in patients not in the study and previous to the study. They do not know at this point if it is lower in the drug patients or the placebo ones. The data remains blind. If the mortality is the same then the study keeps going, if it is lower the study keeps going, if it is higher the safety review is done earlier by the Data Safety Monitoring Board appointed by the FDA. Even without any safety concern suspiciousness the DSMB reviews without blindness at certain set dates/number of patients. They always know and they are amazingly very secret and tight about it. Sometimes they stop the study early due to superior performance by the drug, sometimes they stop it due to side effects from the drug. DSMB/FDA decision.