If you’re here, you’ve probably seen or heard ads on the TV, radio, or even social media about these wonderful opportunities called clinical trials. So now you’re wondering, what is a clinical trial anyway? Keep reading to start learning all you need to know about clinical trials and how to get involved.
What is a Clinical Trial?
A clinical trial is a research study with human volunteers that is evaluating the safety and effectiveness of an interventional treatment before it is allowed to come out on the market. An interventional treatment could be a new drug, device, or even a change in a participant’s behavior.
While all clinical trials are testing new interventions, they are not all structured the same. There are four phases to the clinical trial process before an intervention is approved by the FDA.
- Phase 1: This is the first time the intervention is evaluated in humans. The primary objective is to evaluate if the intervention is safe and how it is absorbed and metabolized. Typically, only 20-100 volunteers are needed over the period of several months.
- Phase 2: This phase is evaluating the efficacy of the intervention. A phase 2 study can last from several months to two years and can include up to several hundred volunteers.
- Phase 3: This phase is a large-scale test that can last over several years to further evaluate both the safety and effectiveness of the intervention. Both the benefits and side effects are measured here. Once this phase is complete, the intervention can apply to the FDA for approval to come to market.
- Phase 4: Also called a Post-Market study, a phase 4 study is conducted to further evaluate the intervention after is has been released to the public. It is here that long term effects of the intervention can be evaluated and compared to other drugs, including how cost effective it is for the pharmaceutical company.
What are the Benefits vs. Risks of Participating?
As with anything, there are benefits to participating in a clinical trial, but there are also risks. It is important for you to measure for yourself and consult with a doctor before enrolling. Here are a few standard benefits and potential risks you may encounter.
- Access to new treatment before it is available to the public
- More oversight and medical care than with your standard care (often at no cost to you)
- You get to play an active role in your own health care
- An opportunity to help others like you get a better treatment option in the future
- There may be serious side-effects to the intervention not yet known
- The intervention may not work at all
- You may get assigned to a control group and receive placebo
- A clinical trial requires a lot of appointments which could be time consuming
How to Get Involved!
If a clinical trial seems like a good option for you and your condition, you can get involved at one of our three locations! Centex Studies has studies enrolling now in the South Houston, North Houston, Lake Charles, and McAllen areas. Browse the enrolling studies on our website or give us a call at 281-918-0048 to see if you may qualify to participate!