New Pharmaceuticals From the Time

New Pharmaceuticals

From the time a new chemical compound is discovered, to the time when (and if) it is available for marketing, it may be many years. Any new drug must be evaluated by a clinical trial - a research study in which human beings are administered the drug and then observed for side effects or physical problems. The clinical trials are broken into several different phases:

Phase I trials use an experiment drug on a very small group. This may be done to identify safety issues or side effects. It can also be used to determine what the dose range for a medication should be.

Phase II trials give the drug to a larger number of people, mostly to see if it works for a certain type of condition, or for more safety testing.

Phase III trials give the drug to a large group, maybe up to 3,000 people. These patients will often have the condition the drug is being used to treat, and this allows the scientists to review information about the treatment and more safety testing.

Phase IV trials are done after the drug has already been out on the market, and tests are continued in an attempt to evaluate the drug's safety and effectiveness.

At any point in the testing process, the drug study may be discontinued, especially if there appears to be a safety issue or else if the drug is thought to have too many side effects for marketability. The cost of the trials falls on the pharmaceutical company, who hopes that the drug will be successful. It is estimated by the FDA (2002) that for 100 drugs that enter Phase I testing, one drug will eventually make it to market.

Anyone can apply to take part in a clinical trial, but the testing facilities and the pharmaceutical companies have strict guidelines regarding who can participate. These are called inclusion/exclusion criteria, and not only protect the participants from harm but also allow the researchers to be sure that the studies they do provide reliable data on the safety and efficacy of the drug. Each person who takes part in a drug study must go through an informed consent process. The potential participant will be given facts about the study, and is allowed to make a good decision regarding whether or not to participate. Even if the participant agrees to join a study, the participant can quit the study at any time. Participants may join a study for many reasons: they may want to try an experimental treatment, or want to help in medical research. Often time's participants will receive some sort of financial benefit for participating in studies, usually based upon the risk or requirements of the study.