THE VIRILITY SOLUTION: CLINICAL TRIALS

Mar
24
2009

Posted by: admin in Categories: Men's Health-Erectile Dysfunction.

Testing a potential mass-market drug is no small matter. It takes time, plenty of money, and patience. When a pharmaceutical company believes it has a marketable drug, it must be submitted to rigorous scientific trials. They consist of actual tests on human subjects and can take a decade or more to complete, with time spent to assemble, correlate, and disseminate the data. Pharmaceutical companies estimate that taking a new medication from the research phase through each of the three, sometimes four, individual experimental trials, to the final submission of the data to the Food and Drug Administration costs $500 million on average. For all the time and money spent, the pharmaceutical company is afforded some protection from competitors. Once a drug gets FDA approval, the company then has two decades in which to exclusively produce and sell that drug.

The procedure for drug trials is always the same. Each promising drug starts out with a relatively small Phase I trial in which the new medication is offered to a select group of patients who have not been helped by conventional therapy. This is not without risk: although the drugs have been tested on animals, toxicity to humans is, at this point, unknown. Phase I trials are usually limited to just a dozen or so patients and generally last up to a year.

If the drug appears to be effective and has acceptable side effects. Phase II begins. Now, dozens of people will receive the drug, while dozens more will take placebos (inert substances). At this time, the searchers are looking at the safety and side-effect profile, but they especially want to know if the experimental drug is more effective than both the placebo and any current therapy used to treat the same aliment. If the drug still seems to be working, then Phase III trials start in which hundreds of subjects, some of whom receive the drug, some of whom get a placebo, are used. Neither group, nor the administering physicians, know who is taking which one. Researchers examine the side effects and effectiveness very closely and also seek to determine optimal dosages of the drug. By Phase IV, the drug has been proven to be effective and researchers are fine-tuning the treatment on test sub-in is, not checking for efficacy, but seeking to determine whether or not any disturbing side effects appear.

Time-consuming as they are, these medical trials are very important. They strive to prove whether the drug works the way researchers claim it will. And they check to make sure that, when dosage reommendations are followed carefully, the patient will be helped. In the end, the overall safety of a drug is a more crucial consideration than its efficacy.