When scientists find a drug they think might be beneficial in the treatment of a disease, they develop what is known as a clinical trial protocol in order to further test the drug and its effects. This is a detailed plan that outlines how the drug will be studied and includes things like what kinds and how many patients will participate in the study, how the new drug will be tested and how the results of the study will be measured. Clinical trials are sponsored by organizations or individuals who are searching for better treatments to diseases. Often trials are conducted by many different scientists at many different sites at the same time, but each particular instance of a clinical trial follows the original clinical trial protocol to ensure accurate results.
In order for the Food and Drug Administration (FDA) to allow a pharmaceutical manufacturing company to sell a drug for the treatment of a disease, the drug must undergo several different clinical trials so that the drug is proven both safe and effective. For a drug to make it through the clinical trial process, it must pass many steps. When a new drug is first moved to the clinical trial phase, it must undergo clinical trials to determine whether or not it is safe for use. After each clinical trial on a drug, the results are recorded and studied to determine whether or not the drug is both safe and effective. If a new drug is proven to be safe in early clinical trials, more trials follow to determine whether or not the drug is effective in the treatment of a disease.
If a new drug is proven to be both safe and effective after several different clinical trials, it is then passed on to the FDA who also examines all the information collected about the drug. The FDA considers how the drug performed in the clinical trials, the side effects the drug seemed to cause and the chemistry of the new drug when it considers if the new drug should be approved. If the FDA approves of a drug after it has been through the clinical trial process, the drug can then move into widespread use.
The clinical trial process is long and complicated but it is designed to ensure that when drugs pass through the FDA for widespread use, they have been proven to be safe and effective for the patients taking them. There are different kinds of clinical trials and each kind is meant to focus on one particular aspect of a new drug, from how safe it is to use to how much more effective it is than the current treatment. Though the clinical trial process my seem convoluted, it is designed to ensure that when a new drug makes it through the process that drug has proven that it is both effective in the treatment of disease and safe for the patient to use.