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Psoriasis Psoriasis Treatment

Enrolling in a Clinical Trial


Medically Reviewed On: November 09, 2005

Clinical trials are research studies that use human volunteers to test the safety and effectiveness of new health interventions such as drugs, surgical procedures and screening tools to diagnose various diseases. The trials generally involve being randomly assigned to either an experimental group, which receives the study treatment, or a control group, which receives either standard treatment or a placebo. In blind trials, participants do not know which group they've been assigned to.

Psoriasis trials often examine investigative drugs, which may have preliminary names like MM-093, CEP-701 and CD7. Trials also may examine the use of an already-approved drug for a new purpose. For example, the eczema medication tacrolimus (Protoptic) is currently being studied for people with psoriasis, while the biologic agent etanercept (Enbrel), which is approved for adults with psoriasis, is now being studied for use in children.

There are several potential benefits to participating in a clinical trial. First, it may allow you to gain access to a new treatment before it becomes widely available. Second, you probably will be closely monitored and receive excellent care while participating in the trial. You will be playing a highly-active role in your own health care, and you can have the satisfaction of contributing to medical research. Finally, in some cases, your care could be free of cost.

Of course, there are several potential downsides to participating in a clinical trial. By agreeing to take an unapproved drug, for example, you may be exposing yourself to unpleasant, serious or even life-threatening side effects. You also run the risk of your psoriasis becoming worse if you don't respond to treatment. Also, some clinical trials can be time-consuming if they require additional doctor visits or questionnaires to fill out.

Fortunately, clinical trials are subject to ethical and legal codes designed to minimize any possible harm to participants. All federally-regulated trials are monitored by two independent committees of experts to protect the participants: the Institutional Review Board and the Data and Safety Monitoring Committee. If you are considering enrolling in a clinical trial, ask the researchers to confirm that both of these committees have reviewed the trial protocol.

People need to sign a consent form before participating in a clinical trial. Regulations dictate that you must understand the key facts about the trial before you decide whether or not to participate, a process called "informed consent." Informed consent means that you have the right to continue asking questions before, during and after the study. Additionally, you can quit a trial at any time.

To find out about psoriasis trials in your areas, visit sites such as www.clinicaltrials.gov or www.centerwatch.com and search for trials that are still recruiting patients.

Questions to ask if you're considering enrolling in a clinical trial:

  1. What is the purpose of the study?
  2. Who is going to be in the study?
  3. Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
  4. What kinds of tests and experimental treatments are involved?
  5. How do the possible risks, side effects and benefits in the study compare with my current treatment?
  6. How might this trial affect my daily life?
  7. How long will the trial last?
  8. Will hospitalization be required?
  9. Who will pay for the experimental treatment?
  10. Will I be reimbursed for other expenses?
  11. What type of long-term follow up care is part of this study?
  12. How will I know that the experimental treatment is working? Will results of the trials be provided to me?
  13. Who will be in charge of my care?

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