Clinical Trials FAQs

Questions about taking part in a clinical trial?

NPF is here to help.

 
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1. What is a clinical trial and what happens during one?

Clinical trials are research studies using human volunteers that are aimed at finding better ways to prevent, screen for, diagnose or treat disease. There are 3 phases (Phases 1, 2, 3) of clinical trials a treatment must pass before the U.S. Food and Drug Administration (FDA) will consider it approved for use by patients. Once approved, the treatment may enter Phase 4 studies (also known as post-marketing studies) which study the safety and efficacy over larger, more diverse populations for longer periods of time. [1]

Clinical trial participants may be sorted into different groups such as a control group or an interventional group. The interventional group may receive a new treatment, while the control group will receive a placebo (a substance that has no therapeutic effect). Depending on the design of the study, the participant, physicians and researchers may not know who is receiving the treatment or placebo. This allows the physicians and researchers to collect data objectively (not influenced by personal bias or judgment).

All participants are given the same level of medical care and attention by health care providers and researchers in the study, with regular follow-ups to monitor safety and efficacy for all treatment groups.

2. Who can participate in a clinical trial?

Different clinical trials may have different eligibility requirements that are used to identify appropriate participants and ensure their safety.

  • Inclusion criteria are factors that allow a person to participate
  • Exclusion criteria are factors that disqualify a person from participating

Some factors that are considered include age, gender, other demographic information and current health conditions. Certain studies may need participants with a particular health condition; others may need healthy participants. For psoriatic disease clinical trials, a factor that may be considered is whether you have psoriasis, psoriatic arthritis or both and the severity of your disease. Studies may also take your previous treatment history into consideration.

3. Why should I join a clinical trial?

Clinical trials are key to medical advancements, with participants being essential for clinical trials. Researchers are able to better understand, diagnose, treat or even to a cure for psoriatic disease through clinical trials. Participating in a clinical trial is a way to be involved with scientific research and give back to the psoriatic disease community.

4. Can children participate in a clinical trial?

Children may be eligible to participate in certain clinical studies. Treatments offered for children have often been restricted due to what was known about the treatments’ safety and efficacy when used in adults. Clinical research in children helps researchers better understand how to treat children. This research may improve treatment dose, method of delivery and our understanding of how treatments affect children as they grow and develop. For more information about clinical trials and children, visit Children and Clinical Studies, a site developed by the National Institutes of Health.

5. What are the potential benefits and drawbacks of participating in a clinical trial?

By participating in clinical trial research, you can be a part of the development of safer and more effective treatment options and possibly help define milestones to a cure for psoriatic disease. However, it is important to weigh the possible benefits and the possible risks to decide what may be best for you.

Possible benefits include:

  • Contribute to psoriatic disease research
  • Access to free and new innovative treatments
  • Receive free medical care
  • Possibly get paid for participating or for costs of travel
  • Experience improvements or even remission of psoriatic symptoms
  • Play an active role in your health care

Possible drawbacks include:

  • As with all treatments, possibly experience a side effect or risk
  • Might receive a placebo with no treatment value
  • Must discontinue all existing treatments during a “washout” period before the trial begins
  • Might experience no improvement or even worsening of psoriatic symptoms
  • May be time-consuming or demanding with regular check-ups
  • May have challenges accessing the treatment once the trial is complete

6. How do I find a clinical trial that is suitable for me?

There are several ways to find a clinical trial:

  • Visit our Finding a Clinical Trial page for resources and information to find studies related to psoriatic disease and other conditions.
  • Speak with your health care provider to learn more about clinical trials that may be recruiting in your area.

7. What happens to me and my treatment plan after a clinical trial?

Your treatment plan after a clinical trial has ended will depend on your plan with your provider, your health insurance and access to health care.

If you are unable to access health care outside of a clinical trial, speak with the research staff about your treatment options after the trial. Or it may be possible to join another clinical trial.

8. What happens to the treatment after a clinical trial?

Using data from the clinical trial, researchers will determine if the treatment should continue to next phase of clinical trials or if the testing needs to be discontinued. If the clinical trial was a Phase 3 study, researchers will determine if the findings are medically important. If they are, researchers will submit their findings to the FDA for approval. The FDA will review all of the data and findings from the clinical trials and make a decision on whether or not to approve the treatment and make it available to the public.

To learn more about clinical trial phases, please visit Clinical Trials 101.

9. Are there clinical trials for biosimilars? What is the FDA-approval process for a biosimilar?

Biosimilars are a type of biologic medicine that are modeled after an already approved biologic (also called the “reference product”). The FDA approves biosimilars according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines.

Clinical trials for biosimilars must demonstrate that there are no clinically meaningful differences between the biosimilar and their biologic reference product in terms of safety, efficacy and immunogenicity (ability to produce an immune response). Biosimilars undergo Phase 1, which examines how the body processes the treatment and any side effects, and Phase 3 studies which examine safety, efficacy, and ability to induce an immune response.

What happens next?

The biosimilar may move to requesting FDA approval if the biosimilar shows no clinically meaningful difference to the biologic reference product.

It is important to keep in mind that biosimilars do not go through a clinical trial for every condition for which it is seeking FDA approval. For example, if a biologic reference product is approved to treat three conditions, a biosimilar can use data from a single Phase 3 study to infer its safety and efficacy for all three conditions (rather than performing separate clinical trials for each condition).

The FDA review and approval process ensures that approved biosimilars are just as safe and effective as their biologic reference product.

10. What if I am not eligible to participate in a clinical trial, but I want to contribute to research?

There are many ways to contribute to scientific research.

  • The National Psoriasis Foundation and Corrona, LLC have developed the Corrona Psoriasis Registry, which helps to advance medical research and improve patient care. Joining this registry will help researchers better understand the safety and efficacy of psoriasis treatments, comorbidities (related health conditions) of psoriasis and the natural history or progression of psoriasis.
  • Citizen Pscientist is the first-ever global online research network designed to increase knowledge and give researchers new information and leads. You get to evaluate the information and data gathered and discuss topics that you find interesting.
  • Donate to Research and help support projects on the leading edge of research into psoriasis and psoriatic arthritis including research aimed at accelerating the discovery, development and delivery of new treatments.
  • Join our team of advocates to urge your lawmakers to increase federal funding for psoriatic disease research.
  • Patient-Centered Research places the you at the center of the research process. You can be involved throughout the research process, from participating in patient surveys, to the formulation of research questions, to the dissemination of results.

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