Learning the Phases of Clinical Trials
When it comes to the world of clinical research, there are several distinct types of trials that may take place. Clinical studies all use human participants to help add to medical knowledge in a given area, but the exact procedures, products and approaches used during these trials can vary widely based on the goals and required safety elements.
At AGA Clinical Trials, our team can help lay out the differences between various trial types. They can also help you determine which might be best for you if you’re looking to lend a hand in any area of clinical research. Clinical trials are conducted in several specific phases – many trials will not make it past a given phase, and this is where many studies begin to differ significantly. Let’s look at what each major phase of the clinical research process is meant for, and the likelihood of a given study progressing past each phase.
Phase 1 trials
Phase 1 is the earliest and broadest phase of any trial, with the goal of narrowing down safety and dosage areas as well as possible. This phase will usually feature somewhere between 20 and 100 volunteers, either healthy or with the condition that’s being studied, and will last a couple months in most cases
While researchers will already have done a great deal of work looking into proper human dosages and other safety areas, this is the stage where they fine-tune these and ensure all participants are safe before opening the trial up to larger populations. In general, about 70 percent of new treatments will pass through the first phase and into the next one.
Phase 2 trials
As you’ll see here, clinical trials heavily emphasize safety above all else – phase 2 is designed for this area as well, even though things can’t even reach this point without passing through phase 1. Phase 2 involves opening up the trial to several hundred people, and generally most of these will have the condition being studied. Researchers are looking for information on how safe a given treatment is, but also how effective it is at reducing or eliminating desired symptoms. Phase 2 trials can last anywhere between a couple months and a couple years.
Phase 3 trials
During phase 3, which will have thousands of volunteers in many cases, researchers look for any adverse reactions that might be present with a given treatment. Most phase 3 trials tend to last for at least a year, and up to four years in some cases. Roughly 25 to 30 percent of all treatments make it through phase 3 and on to phase 4.
Phase 4 trials
Phase 4 is again a large one, with several thousand participants in most cases. This phase is only used after a product or treatment has been approved by the FDA, and will even further test efficacy and safety across a broad portion of the population.
For more on the phases of clinical studies, or to learn about any of our clinical research volunteer opportunities (including for healthy volunteers), contact the pros at AGA Clinical Trials today.