The pharmaceutical industry is one of the largest and most profitable on the planet. It is also one of the most important. Every day, millions of lives are saved and millions more are improved by over the counter and prescription medications. The process by which the drugs go from the lab to the store is called clinical trials and they are a very important part of the clinical drug development process.
During the clinical trial process, pharmaceutical companies conduct medical research studies to collect the data they need on how effective and safe their drugs or devices are. The clinical trial process has several stages that indicate the approval process. A new drug or device must clear each before it can move on to the next and all must be passed before the medication or device can even be considered to be sold to the public. Even if a drug or device passes, it still may not make it to the market.
Before a drug can make it to the clinical study phase it needs to have gone through extensive laboratory testing first on animal subjects and then on human cells. This initial process can take a long time. Most often this process takes years. When a drug company has a product that they would like to see advance to the clinical trials stage, they have to get approval from the U.S. Food and Drug Administration (FDA).
Once the FDA has looked at the preliminary research and has given its approval, clinical trials can begin on human subjects. There are typically four phases to the clinical trials. The different phases are each considered to be completely separate. Drug companies are required to compile the data and send it to the FDA after each phase has reached completion. FDA approval is needed to move a drug or device onto the next phase.
Human Clinical Trial Phase I:
The phase 1 clinical trial has one real goal. That goal is to ascertain how safe a product is. This can be thought of as the “first, do no harm” section of the clinical trials process. What normally happens in this phase is the company finds between 20 to 100 healthy people to volunteer. These people are called volunteers but they are paid for their participation in the study. This process takes at least several months to complete and looks at how the drug impacts the people who take it. Researchers look at the way the body absorbs it, metabolizes it and gets rid of it from their bodies. Any negative (or positive) effects are recorded.
Human Clinical Trial Phase II:
In phase II, researchers begin to look at how effective the product is on treating the problem for which it was created. This is a longer process and can last anywhere from just a few months to more than two years. The pool of people who are a part of the testing is increased to at least several hundred people. These clinical trials are randomized so that there are two groups of people studied. One group is given the drug that is being tested and the other is given a placebo. A common practice is to do a blind study where the researchers are not informed about who is given the medication. Only about 30% of new drugs make it through this trial.
Human Clinical Trial Phase III:
These clinical trials are both randomized and blind. The pool of people is expanded again. This time the pool can range from a few hundred to a at least a few thousand. This phase will last at least a few years. This also gives both the drug company and the FDA a lot more information on how the drug works and how effective it can be. The success rate for drugs that make it to this phase is between 70 to 90%. This is when the process for final FDA approval and marketing can start.
Human Clinical Trial Phase IV:
These are given the name “post marketing surveillance trials.” The new drug or device has already been approved for consumer use by the FDA. This phase is mostly for the company to learn more about their product. The drug company uses this to monitor the long term impact of their product.