Clinical Trials FAQs

 

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

 

A clinical trial is a type of research study involving human participants who receive the drug or treatment that is being investigated. There are usually three phases (I, II and III). Findings about safety and efficacy are used to determine whether a drug or treatment will be approved and made available for prescription.

Participants are generally split into a group that receives the investigated treatment, a placebo (an inactive pill, liquid or powder that has no treatment value) or a currently approved treatment. 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.

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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 are age, gender, other demographic information and current health conditions. Certain studies may need participants with a certain 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. Studies may also take into consideration your previous treatment history.

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3. Why should I join a clinical trial?

 

Clinical trials are key to medical advancements. And participants are essential for clinical trials. Researchers are able to better understand, diagnose, treat or even cure a condition through clinical trials. Participating in a clinical trial is a way to be involved with scientific research and also give back to the psoriatic disease community in addition to being an opportunity to receive a new treatment and access to free medical care.

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4. Can children participate in a clinical trial?

 

Yes, 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 help researchers better understand how to treat children. This research may improve treatment dosage, 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.

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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 even 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 pros 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 cons 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 or psoriatic symptoms
  • May be time-consuming or demanding with regular check-ups
  • May have challenges accessing the treatment once the trial is complete

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6. How do I find one that is suitable for me?

 

There are several different ways to find a clinical trial:

  • Use our NPF Clinical Trial Finder, which allows you to customize your search by whether you have psoriasis, psoriatic arthritis or both, location and other details.
  • Search ClinicalTrials.gov for studies that include other conditions.
  • Speak with your health care provider to learn more about clinical trials that may be going on in your area.

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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 health insurance and access to health care.

If you already have health insurance and a health care provider, work with the research staff to help coordinate with your health care provider on a treatment plan after the trial has ended.

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.

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

 

All of the data that is collected during a clinical trial is analyzed to determine how safe and effective it is. All data is de-identified so that no one will know an individual’s specific information. Researchers will use these findings to determine whether to stop testing or to move to the next phase of clinical trials. Results from a clinical trial are often published in scientific journals and on ClinicalTrials.gov.

If the clinical trial was a Phase III study, researchers will determine if the findings are medically important. If they are, researchers will submit their findings for publication and to the FDA for approval. The FDA will review all of the data and findings from the clinical trial and make a decision on whether or not to approve the treatment and make it available on the market.

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

 

Biosimilars are a type of biologic medicine. Like biologics, biosimilars are medicines made from living sources. Biosimilars are modeled after an already approved biologic (also called the “reference product”). They are highly similar to biologics.

There are clinical trials for biosimilars. However, the clinical trial phases for biosimilars are different from clinical trial phases required for other drugs or treatments. 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). This means that they are just as safe and effective as their biologic reference product.

PHASE
I

Who can participate?

Small group of healthy or patient participants

How long is this phase?

Several months

What is being learned?

How similar the biosimilar is compared to the biologic reference product in:

  • How the body processes the treatment
  • Side effects of the treatment in the body

What happens next?

The biosimilar may move into a Phase III pivotal trial if the biosimilar shows no clinically meaningful difference to the biologic reference product.

PHASE
III
pivotal
trial

Who can participate?

Large group of patient participants

How long is this phase?

Several months to two years

What is being learned?

How similar the biosimilar is compared to the biologic reference product in:

  • Safety
  • Efficacy
  • Immunogenicity

What happens next?

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

 

The findings from the biosimilar clinical trials and analytical studies during development are submitted to the FDA to review and determine if the biosimilar will be approved to go to market. It is important to keep in mind that biosimilars do not go through a clinical trial for every condition that it is seeking FDA-approval of - For example, if a biologic reference product is approved to treat 3 conditions, a biosimilar can use data from a single Phase III Pivotal Trial to infer its safety and efficacy for all 3 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.

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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:

  • NPF works with a health research company called Corrona, LLC. Together, we have developed the NPF/Corrona Psoriasis Patient 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.
  • NPF’s Citizen Pscientist is the first-ever global online research network designed to increase knowledge and give researchers new information and leads. You get to play with the information and data we gather and discuss topics that you find interesting.
  • Join our team of advocates to urge your lawmakers to increase federal funding for psoriatic disease research.
  • Donate to NPF’s Discovery Fund. The Discovery Fund is dedicated to funding scientific research aimed at accelerating the discovery, development and delivery of new treatments that may one day lead to a cure for psoriasis and psoriatic arthritis.

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