Clinical research is a crucial way of getting new medical interventions into the field, whether those are drugs, treatments, or other types of interventions. From Phase 1 clinical trials to Phase 3 clinical trial drugs, every step of the process is essential to ensure that safe, effective treatments can constantly be developed.
Step 1: Design
In the first step, researches design a trial in order to answer specific questions they have about a drug or treatment. Some of the things the researchers must plan in advance include:
- How many people will take part
- What assessment will be conducted
- How data will be collected
- How data will be analyzed
- How long the study will last
- Who can participate
- How the drug will be administered and what amounts
. Once the clinical research has been designed, the trials will move from Phase 1 drug trials to a Phase 2 clinical trial, and finally to Phase 3 clinical trial drugs.
Step 2: Phase 1 Trials
These early trials involve only a few volunteers and are usually open only to those with a particular need or disease that the drug might be useful in treating. Alternatively, some Phase 1 trials will instead involve people who are healthy. Usually, there are no more than 20 to 100 volunteers at this stage, and the primary purpose of the study is to determine if the drug is as safe as researchers have theorized and what dosages are appropriate. About 70% of all drugs that reach this stage will move on to Phase 2 trials.
Step 3: Phase 2 Trails
In this stage, several hundred people are usually involved, and all of them with a particular disease or condition that it is believed the new treatment will help with. This phase is longer and typically takes between several months and as long as two years to complete. The purpose of this stage is to check that the treatment is as efficacious as is hoped and to further evaluate side effects. About 33% of the drugs that make it to Phase 2 trials will then go on to be tested as Phase 3 clinical trial drugs.
Step 4: Phase 3 Trials
Phase 3 clinical trial drugs are used on hundreds or even thousands of volunteers. These volunteers will be those who have a disease or condition that the Phase 3 clinical trial drugs are designed to treat, and the trials will typically last between one and four years. The purpose of this stage is to further evaluate how useful the drugs are and to check a wider range of people for possible side effects that might not have manifested in earlier stages when there were fewer people involved in the study. Only about 25% to 30% of Phase 3 clinical trial drugs will pass this phase and move on.
Step 5: Phase 4 Trials
Although this stage is technically known as Phase 4, the drug will be released for general use once it has passed through Phase 3 trials. Even though the drug is now being used more widely by the public, the FDA and other research organizations will be keeping a close eye on it for a few years to make sure there are no unexpected reactions or events surrounding its use.
Clinical research trials are some of the most important parts of modern medicine. They help us make sure our drugs are safe, our treatments are effective, and innovation in the field of modern medicine continues to advance.