Once the research has ended the testing begins.
Without it, clinical trials for new drugs and medical devices would never reach consumers. It is a very careful and painstaking process and with good reason: The safety of the consumers. There are four phases to clinical trials, each with a distinct purpose. Let’s learn a little more about clinical trial phases with a little help from the FDA (See infographic).
Phase 1
The purpose is to figure out if the new drug or device being tested is safe. It can take months or even years to complete in some cases. The test will include healthy volunteers. Generally participants are paid for their participation. A large percentage of experimental drugs and devices pass through this phase of testing.
Phase 2
This phase is to test the efficacy of a new drug or medical device. Again, it last for months or even years.They are randomized trials where some participants receive the experimental drug and there is a control group that gets a standard treatment or placebo. In some cases this phase is done “blind”. This means the patients and the researchers know who has received the experimental drug and who has been given the standard treatment. Only about a third of experimental drugs or medical devices get past this phase.
Phase 3
Once a drug or device reaches this phase it is ready for a larger group of participants. This phase will have a larger group of participants from a few hundred or even thousands. The tests are random and blind. Most of the drugs (up to 90%) will complete this phase successfully. This is also the step where the pharmaceutical company can request approval from the Food and Drug Administration (FDA).
Phase 4
The last phase in the four phase process is typically called Post Marketing Surveillance Trials. Once the drug or device is approved and the consumer can purchase it, pharmaceutical companies look to find out how they compare to other drugs and devices already available as well as look at the long term effects of the drug or device.
Participants are needed for the first three phases of clinical trials, so search our clinical trial database and see if there is one that fits your needs!