The primary purpose of a clinical trial is to test the effectiveness and safety of a drug or any medical device. Organizations conduct them under the aegis of the company manufacturing the drug or device.
These trials include volunteers, doctors and other professionals such as nurses. Drug and device trials have four distinct phases.
Phase 1 drug trials are where a healthy volunteer is given the medicine and tests for side effects. Phase 2 and 3 go further with tests to see if it is safe, effective and what dose is most effective. Only after the drug passes these three phases does the FDA approve the product.
Every phase of a trial must follow strict protocols set by the FDA and certified by Independent Review Boards.
Researchers first review drug-related information and then make a list of objectives they want to achieve. The next step is to make questions and decide the following:
• Length of study
• If there will be a control group
• How the drug will be administered and dosage
• Assessment and data collection
• Review of data and analysis
Pharmaceutical companies must submit an Investigational New Drug application process before announcing a trial. They must include data sheets and other information required by the FDA before they can proceed.
Researchers usually ask for volunteers for a trial, those who are healthy and others with a specific condition. Drug trials usually start when a lab test shows that a new treatment method looks promising. This phase intends to determine the following:
• What dosage is safe for people?
• What are the side effects?
• What is the average body’s tolerance for the drug?
• Are there any noticeable effects?
Drug dosage is slowly increased in groups of volunteers to determine the optimal dose. Participants must get a lot of blood tests to determine the efficacy of the drug.
The bottom line is that many terminally ill people turn to trials as a last resort. There have been instances where people’s condition have improved due to their participation. This is just the first step in the process and drugs must undergo a lot more testing before providers can offer them to the public.