In order to develop new drugs and medical procedures, researchers need to conduct clinical trials. As a result, there are a large number of these trials that take place within the United States. A recent survey on this topic revealed, however, that approximately 96% of the participants had never participated in a clinical trial. This is interesting to note, as roughly 46% of the participants believed that clinical trials were valuable to the health care system. Furthermore, these individuals also indicated that they considered clinical trial participation to be the equivalent of donating blood.
When people participate in medical research studies, informed consent is required. This is considered to be so important that there is a specific section on informed consent in the ninth revision of the American Psychological Association’s Ethical Code. In the event that researchers plan to have children under the age of 18 participate in clinical drug development, they are legally bound to obtain a parent’s or guardian’s consent.
In order for a new drug or medical procedure to be approved by the Food and Drug Administration, it must complete four separate phases. It’s important to note that while 5,000 to 10,000 drugs may enter the research and development process every year, just 250 of these are tested in a pre-clinical trial. Out of these 250, just five are tested in a clinical trial, and only one tends to be approved by the Federal Food and Drug Administration.
There is a specific purpose for each phase of a clinical study. During a Phase 1 clinical trial, for example, an experimental drug or treatment is tested for the first time. The size of the group is usually between 20 to 80 people. At this stage, the clinical team’s purpose is two-fold. First of all, they need to determine whether or not the drug or treatment is safe. Secondly, they need to identify any side effects.
When a Phase II trial is underway, the experimental drug or treatment is administered to a group of 100 to 300 people. At this stage, the purpose is also two-fold. In addition to determining whether or not the drug or treatment is effective, its safety is also further evaluated.
During Phase III trials, the experimental drug or treatment is administered to between 1,000 to 3,000 people. There are four purposes at this stage of a clinical trial:
- To confirm the experimental drug or treatment’s effectiveness
- To monitor side effects that may arise from the experimental drug or treatment
- To compare the experimental drug or treatment with standard or equivalent protocols
- To collect data so that the experimental drug or treatment can be safely used
Upon the completion of Phase IV, a New Drug Application will be submitted by the clinical trial team. If approved by the Food and Drug Administration, the drug or treatment will be available on the market. As previously stated, there is usually just one drug or treatment that will make it through this entire process.
New drugs and medical treatments continue to be needed for a variety of diseases and health conditions. When people have the opportunity to participate in clinical trials, they are making valuable contributions to the medical field. Furthermore, by participating in clinical trials, the participants are in a position to potentially help themselves and others.