The term ?clinical trials? can sound scary, but the realities are very different from what you might imagine. Clinical trials are medical research studies attempting to develop new medical treatments for any number of conditions. They are carried out by professional doctors and are closely monitored to ensure patient safety. If you are considering entering a clinical study you may have questions. Here is some information to help you understand the process.
- Why Do We Need Clinical Trials?
Clinical trials are essential to the advancement of modern medicine. Any modern medical strategy, treatment, or device has been through an extensive clinical trial before being approved for the general public. They are a necessary step in clinical drug development and are also used to determine what methods are most effective against certain illnesses or certain groups of people.
- What is Informed Consent?
Informed consent is required before enrolling in any clinical trial. Whatever the goal, you must be given adequate information on the methods, goals, and possible risks and benefits of the trial. Informed consent is so important that the American Psychological Association has dedicated an entire section to it in their official ethical code. It is important that you know exactly what you can expect from the trial.
- Can Clinical Trials Include Children?
Yes, some clinical trials include children. If a child under the age of 18 is to be enrolled in a clinical trial it is legally required to obtain informed consent from their parent or legal guardian. Studies on children are necessary to evaluate treatments specifically intended for children. A child’s physiology is slightly different from that of an adult. So while a trial may prove something is effective for adults, the same treatment may not be as effective when applied to a child.
- What are Phase 1, Phase 2, and Phase 3?
The clinical trial process can be confusing. While the details can vary, there are always four distinct phases in any clinical trial. A phase 1 clinical trial involves a small number of participants, between 20 and 80 people, and is intended to test the safety and identify side effects of the new drug or treatment. Phase 2 expands the number of participants to roughly 100 to 300 people and further tests the safety of the drug or treatment and examines its overall effectiveness. Phase 3 requires a large number of participants, 1,000 to 3,000 people, and is required to confirm the drug or treatment’s effectiveness, monitor longer term side effects, compare it with current equivalent treatments, and collect information to ensure the drug or treatment is administered and used safely.
- How Do Clinical Trials Benefit Me?
Clinical trials can be of great benefit to the individual. If you are enrolled in a trial you could have access to cutting edge treatments that may prove more effective than current methods. Even if you are not enrolled in a trial you still benefit from any successful treatments that are approved through that study.
- How Do Clinical Trials Benefit Society?
Clinical trials are also important to society at large. They are used to gain a greater understanding of human physiology and what treatments are effective. When something new is approved everyone then has access to a new treatment. This process saves lives and helps build a healthier society for us and future generations.