Drugs for psoriasis and other health conditions must pass rigorous testing before they are introduced to the general public. These tests involve a small amount of people at first and as they move through the process, the number of people increases, until the Food and Drug Administration is satisfied that they are safe to use and effectively treat psoriasis or the health condition that they are meant to help.
- Phase I – the first step works to determine how a drug works on humans, including how it is absorbed and metabolized and what the side effects may be. The drug is tested on a small group of people; there are usually between 20 and 100 participants. Only about 70 percent of drugs continue on to Phase II.
- Phase II – The second phase can take anywhere from a few months to a few years. The drug is tested on several hundred patients for effectiveness and safety. In this phase, the testing is often blinded, which means some participants receive a placebo and some receive the drug. Neither the patients nor the doctors know which a participant receives. Only about one-third of medications tested continue to Phase III.
- Phase III – This is similar to phase II. However, there are many more participants, often several hundred to several thousand. Safety and effectiveness are important, but researchers are also looking to better understand both the benefits and risks of a treatment. A large majority – between 70 and 90 percent – of treatments that made it to Phase III continue to Phase IV. Once a drug has successfully completed Phase III, the pharmaceutical company can request FDA approval.
- Phase IV – This phase begins after a medication has been approved by the FDA. During this phase, drugs are compared to those already on the market and pharmaceutical companies look at the cost-effectiveness of the treatment. Additionally, long-term effectiveness is evaluated.
Each phase of a clinical trial needs patients to undergo treatments that are still in the experimental stage. Before you decide if you want to seek out and participate in a clinical trial, you should understand the benefits and risks.
What are the benefits of participating in a clinical trial?
One of the main reasons people with psoriasis choose to participate in a clinical trial is to try a new treatment. They might have tried several that are already on the market but their psoriasis has not responded. They want to find a better way to manage the disease. For some people, trying a new and yet untested treatment is a better alternative than living with uncontrolled psoriasis.
Another reason is it is cost-effective. Patients do not pay anything to be part of a clinical trial. They receive the medication and all related medical treatment, including doctor’s visits and lab tests, for free. Some research centers will pay a stipend for time and travel expenses. For those who don’t have health insurance or have a high deductible, free treatment makes it well worth joining a clinical trial.
Of course, when you participate in a clinical trial, you aren’t just helping yourself, you are helping others. You are making a difference through your participation. You are helping to improve treatments through your feedback.
What are the risks of participating in a clinical trial?
Clinical trials are testing grounds for new medications. There may be unwanted side effects and the treatment might not be effective. You might find that the new treatment isn’t right for you or you can’t tolerate the side effects. It’s important to remember that you have the right to leave a study anytime you want. If you were receiving medical care through the study, it will stop when you elect to leave.
Sometimes the time and travel needed for the study are prohibitive. Unless you live close to the center completing the study, you might need to take time away from work to attend doctors’ visits or speak with a researcher. Although some studies provide a stipend, you might not find it to be adequate to cover your costs.
There is a risk of long-term effects and safety issues. One of the goals of a clinical study is to look at the long-term effects of a medication. However, the results might not be known for months or years after you took the medication.
Finding a clinical trial
Clinicaltrials.gov has a database of public and private clinical studies for a variety of medical conditions, including psoriasis. You can search based on your criteria, including searching for a trial for a specific drug.
The National Psoriasis Foundation also has a community board that actively discusses clinical trials. This is a good place to talk to other people who have participated in clinical trials for psoriasis treatment to find out more about their experiences.
See more helpful articles:
Eileen Bailey is a freelance health writer. She is the author of What Went Right: Reframe Your Thinking for a Happier Now, Idiot’s Guide to Adult ADHD, Idiot’s Guide to Cognitive Behavioral Therapy, Essential Guide to Overcoming Obsessive Love, and Essential Guide to Asperger’s Syndrome. She can be found on Twitter @eileenmbailey and on Facebook at eileenmbailey.