Clinical trials help researchers learn more about how a disease works and how to treat it. If you have psoriasis, you may want to participate in a clinical trial — a study that tests how well new treatments work on people. These trials help researchers gather information about diseases while providing participants access to the latest treatments or extra care for their condition.
Before you join a clinical trial, here are seven things you should know about the studies.
Clinical trials are conducted in four phases. If you have psoriasis and join a clinical trial, you are likely joining in phase 2, 3, or 4.
In phase 1, a new drug or treatment is given to a small group of people — usually 20 to 100 participants — to learn about its safety and side effects. Usually, this initial phase involves healthy volunteers who do not have psoriasis.
Phase 2 studies aim to find out if the new treatment can improve psoriasis. This phase involves a larger group of people — usually 100 to 300. Including more people gives researchers a better chance of recognizing any side effects of the new treatment. Phase 2 studies usually last a few months to two years.
Phase 3 clinical trials collect information about how effective and well tolerated the new treatment is in a much larger group, usually several thousand people in different locations around the world. These studies usually last between one and four years. When the study is complete, the U.S. Food and Drug Administration (FDA) will decide whether to approve the treatment.
Phase 4 clinical trials take place after the new treatment is FDA-approved so that researchers can learn more about it in the general population. Phase 4 trials can study how a treatment works when people take it under real-world conditions and not in a controlled trial.
It’s possible that you won’t be selected to participate in a clinical trial because you don’t meet the eligibility criteria. Eligibility criteria refers to the protocol in a clinical trial that describes who should be included and excluded.
It’s important to have a diverse group of people involved in clinical trials because different people can experience the same disease in different ways. The eligibility criteria help researchers make sure that they have information about how a treatment affects different groups of people. People of color are especially underrepresented in clinical trials.
Eligibility criteria to participate in a clinical trial for psoriasis may include factors such as your:
The protocol may also consider if you are pregnant or if you have other medical conditions. For example, some studies for psoriasis may include or exclude you if you have psoriatic arthritis or other autoimmune diseases.
Researchers may also evaluate the severity of your psoriasis before enrolling you. A common way to do this is with the Psoriasis Area and Severity Index (PASI). The PASI combines your answers from a short questionnaire and a doctor’s evaluation to give you a score indicating the severity of your psoriasis symptoms.
The amount of risk involved in a clinical trial depends on the study and the type of treatment tested. Risks include the time involved, discomfort, and adverse events (side effects) of the treatment being studied.
An institutional review board (IRB) makes sure the potential benefits outweigh any potential risks of a clinical trial. The IRB reviews the research and evaluates risks before and during the study to protect the safety of the people participating.
You can learn about the potential risks of the clinical trial before you enroll through a process called informed consent. This process gives you a chance to learn about the purpose of the study and any possible benefits and risks.
The research staff will provide you with written information about the study that you must read and sign before participating. They should help you understand all the information and give you plenty of time to decide whether you want to participate.
Even if you sign the informed consent documents, you can refuse to participate for any reason before or during the study.
A MyPsoriasisTeam member reminded others, “Remember, if you participate in a clinical trial, there’s a chance you might get the placebo medication.”
There are different types of clinical trials, depending on the study’s goals. Some standard design elements help scientists show that a new treatment is safe and effective.
One method is to compare the treatment being studied to a placebo. A placebo is designed to look just like the new treatment but without any active properties. Studies that use placebos are known as placebo-controlled studies.
If you participate in a clinical trial, you won’t know if you have the active treatment or placebo because most studies are double-blind, which means that neither you nor the researchers know what treatment you received. Double-blind studies are randomized, so you will be randomly selected to be part of either the active intervention or placebo intervention group.
By participating in a clinical trial, you have an opportunity to take an active role in your health care and help others with psoriasis get better treatment options in the future. This alone can be a rewarding experience.
Many clinical trials also offer compensation in the form of cash, time and travel reimbursement, and free medical care.
Some treatments for psoriasis have been around for a long time, like phototherapy. As scientists begin to better understand how and why psoriasis causes disease, they develop more treatments. Clinical trials allow researchers to learn the effects of these new treatments on real people.
Some of the psoriasis treatments you may see in the future include new drugs that work in a similar way to existing treatments, such as:
Other treatments in development target different parts of the immune system to decrease inflammation. Some of the new targets for drugs include:
Psoriasis treatments have made many advances in recent years. Even so, some gaps in treatment remain. Some of the areas researchers may focus on in the future include:
Researchers are also exploring the potential use of psoriasis vaccines.
If you are looking for a clinical trial for psoriasis, try contacting local dermatology offices and ask if they are participating in any clinical studies that you may qualify for. A MyPsoriasisTeam member recommended, “Get on Google and look up dermatologists in your city. Call each one and ask if they are holding any clinical trials.”
|You can also search for clinical trials on clinicaltrials.gov or with the National Psoriasis Foundation’s online clinical trial finder.|
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Have you participated in a clinical trial for psoriasis? Do you have questions for others who have been part of a clinical trial? Share your experience in the comments below, or start a conversation by posting on your Activities page.