What is a clinical trial?
A clinical trial is a research study used to determine whether new drugs or treatments are safe and effective. It involves volunteers, and takes place in a variety of locations, such as hospitals, universities, doctors' offices or community clinics.
A clinical trial is designed jointly between the organization, such as a biotechnology company, conducting the research and the U.S. Food and Drug Administration (FDA) in order to guide the rules of the trial—also known as "protocol"—including who may participate, the schedule of tests, procedures and medications, dosages and length of the study.
The FDA also requires that an Institutional Review Board (IRB) approve and monitor the trial in order to protect the participants. The IRB—made up of doctors, statisticians, researchers, community representatives and others—ensures that a clinical trial is ethical and that the rights of study participants are protected.
Follow the phases
Clinical trials spring from the development of a psoriasis or psoriatic arthritis drug or treatment that begins as an idea in a laboratory. Once this idea is developed into an actual product, it is tested in animals. If this stage is successful, the biotechnology company provides this data to the FDA and requests approval to begin testing in humans. This first phase of research and development can take years, and very few of the initial "ideas" actually make it to human studies.
The next step is a Phase I study, where the new treatment is tested on a small group of people to determine a safe dosage range and how the treatment is processed by the body. Often subjects studied in a Phase I trial don't have psoriasis or psoriatic arthritis or any other disease. The goal is to study safety in healthy subjects.
In Phase II, the study treatment is given to participants to assess effectiveness and to evaluate safety (what the side effects are).
Phase III involves a much larger number of participants, such as more than 1,000, to confirm effectiveness and safety, monitor any side effects and sometimes to compare the study treatment with commonly used treatments.
The first steps
All clinical trials have guidelines about who can participate. Age, type and/or severity of disease, medical history and current medical condition are all considered as part of the "inclusion/exclusion" criteria. Those who meet the criteria and want to participate are given a medical exam and might be given blood tests.
Informed consent documents will include details about the study, including: why the research is being done; what the researchers want to accomplish; what will be done during the trial and for how long; risks involved; and expected benefits. Participants may withdraw from the trial at any time.
At this step, they are also told whether the study might include a placebo (an inactive pill, liquid or powder that has no treatment value) and what to expect in terms of time commitment.
Monitoring of progress
To ensure accuracy, the researchers and patient participants are usually "double-blinded," meaning neither side knows who is on active drug or placebo. This is thought to produce objective results because the researchers' and the participants' expectations about the experimental drug do not affect the outcome.
Researchers also monitor for the drug's safety and whether it is likely to cause adverse events. Adverse events could include side effects from the medication or could be a cold that may or may not be related to the trial. At the end of the study the doctor evaluates the likelihood that the drug caused the adverse events, and will make a designation of "likely" or "unlikely."
Most studies will allow the patient to take other standard medications, such as antibiotics or aspirin, to treat other health conditions. However, patients may want to work with their doctor so that other medications or treatments do not conflict with the study's protocol.
Benefits and risks of participating
One benefit of participation is the possibility of gaining access to a new and effective treatment for psoriasis and/or psoriatic arthritis. Additionally, some clinical trials will provide compensation for the time and expense of participating.
However, the treatment may not work for that person, may take a long time to work, or may simply have too many side effects for the participant to tolerate.
Participating in a clinical trial means helping others by contributing to medical research by advancing the development of better treatments for psoriasis and/or psoriatic arthritis.
Good to know
Before you get involved in a clinical trial, it's important to consult with your doctor and consider the following:
- Who is sponsoring the trial?
- Will I have to pay to participate?
- Will I be compensated for my participation?
- What kinds of treatments, procedures and/or tests will I have during the trial? Will they be painful or uncomfortable?
- How long will the study last?
- Will I be able to take my regular medications during the trial? What medications, procedures or treatments must I avoid while in the study?
- What will be my responsibilities during the study?
- What are the risks and benefits, both immediate and long term?
- Can I remain on this treatment even after the trial is over?
Sign up to participate in clinical trials in your area
Register at TalkPsoriasis, the NPF's online community of people with psoriasis and psoriatic arthritis, to get information about clinical trials near you.
More information about clincial trials including the trial's purpose, participation information and location, can be found here.