Clinical Trials

What is a clinical trial?

A clinical trial is a medical research study that finds ways to more effectively prevent, diagnose or treat diseases in humans. Clinical trials measure the safety and effectiveness of new treatments, like a new medication or a new use of an existing medication; medical devices (such as pacemakers); or tests and procedures for diagnosing illnesses. To be considered for a clinical trial, participants are assigned the experimental treatment (and in some cases placebo), to measure the effect of the experimental treatment on some aspect of human health.

Before an experimental treatment, device or procedure can be tested in a clinical trial, it must have shown benefit in laboratory testing, animal research studies or research in a small group of humans. Clinical trials must follow the same (and often stricter) ethical and legal guidelines as standard medical practice to protect the safety of participants. Those laws are made to make sure that the studies do not cause harm to people.

The American Liver Foundation receives contributions and funding from clinical trial and study sponsors but does not evaluate or endorse any clinical trials or studies, and is not affiliated with any of the sponsors.

Check out Current Featured Clinical Trials

How to Participate

People take part in clinical trials for many reasons. When you volunteer to participate in a clinical trial, you help researchers learn more about curing, preventing, and treating liver disease and its complications, as well as improve healthcare for people in the future. In addition to helping others, you get extra care and monitoring from the clinical trials staff and may receive the newest treatments for a disease.

Clinical trials are required to follow the same ethical and legal guidelines as standard medical practice to protect the safety of participants. However, before participating in a clinical study it’s important that you to talk to your healthcare provider and learn about the study’s potential risks and benefits.

If you’re thinking about participating in a clinical trial and would like more detailed information, the NIH Clinical Trials and You website is an excellent resource.

Phases of Clinical Trials

Clinical trials are done in phases. Each phase of the clinical trial has a different purpose.

  • PHASE 1 - Experimental treatment is given to a small group (20 to 80 people) for the first time to evaluate its safety, dosage range and side effects.
  • PHASE 2 - Experimental treatment is given to a larger group (100 to 300 people) to evaluate its safety and effectiveness.
  • PHASE 3 - Experimental treatment is given to large groups (1,000 to 3,000 people) to confirm its effectiveness, monitor side effects and compare to current standard of care treatments or placebo.

If the experimental treatment works well in a Phase 3 trial, researchers can apply to the U.S. Food and Drug Administration (FDA) to ask for permission to make the treatment available to the public. The FDA approval process takes about a year. The FDA’s review process is carried out in different stages to review the clinical trial’s research and data and to decide if it can be a helpful treatment.

In some cases, research continues even after the FDA has approved a treatment. The FDA can ask researchers to conduct a Phase 4 trial in which researchers collect all the information they have on the experimental treatment’s long-term safety and effectiveness after the drug is approved.

Benefits and Risks of Clinical Trials

Potential benefits of clinical trials include:

  • Access to new research treatments
  • Access to specialists and/or expert care
  • Contributing to medical research that can help other people

Potential risks associated with clinical trials include:

  • Serious side effects
  • Unsuccessful treatment outcome
  • Inability to participate in other trials

Is a clinical trial right for me?

The decision to participate in a clinical trial should involve talking to your doctor, your family and caregivers, the clinical trial team and sometimes your insurance company to see if it is an option for you.

Will health insurance cover a clinical trial?

Many states have laws or agreements requiring health insurance plans to cover at least the cost of routine care when participating in clinical trials. However, health insurance coverage of clinical trials may be different depending on the company, the plan, and the location of theclinical trial. You should check with your insurance company before you sign up for a clinical trial so that you will know what is or is not covered ahead of time.

Can anyone take part in a clinical trial?

Every clinical trial has guidelines and requirements about who can participate, depending on the goals of each trial.

Different trials perform studies on people from all backgrounds. Some clinical trials may be looking at how different tests work on people who have certain illnesses. Some may look only for people of a certain age, gender, race, ethnicity, or with a specific disease, stage of disease or treatment history. Others may be looking for people without serious health conditions.

What happens if I qualify for a clinical trial?

If you qualify for a clinical trial, you will speak with the clinical trial team before you begin. The clinical trial protocol includes but is not limited to:

  • Clinical trial process, including tests that may be conducted
  • Known risks and benefits of experimental treatment
  • Length of clinical trial
  • Clinical trial contact information
  • Contact information for the team who is doing the research

What is Informed Consent, and what is the process?

The Informed Consent process includes providing the above details, as well as explaining your rights as a research participant. If after receiving all this information you fully understand the study and wish to voluntarily participate in the clinical trial, you will be asked to sign an Informed Consent form.

You may choose to stop participating in a clinical trial at any time, even if you have signed the Informed Consent form. You should keep a copy of your Informed Consent form, whether you stay in the trial or choose to leave.

Are people paid to take part in clinical trials?

Some clinical trials offer financial compensation, while others do not. You should ask about payment or costs associated with clinical trials so you are aware of everything in advance.

How do I find clinical trials?

For information on clinical trials in your area or across the nation:

What are the next steps if I am interested in a clinical trial?

Speak to your doctor for his or her input. When you are ready to find out more information about the clinical trial, reach out to the clinical trial’s coordinator to see if you meet the requirements. Their information is public and should be included in any announcement about the trial.

If you meet the initial requirements, you will be scheduled for a pre-trial screening during which tests will be done to help researchers decide if you are a candidate for the trial. The pre-trial screening will also be an opportunity for you to learn more about the clinical trial, including its benefits and risks. Screening can include a combination of phone interviews, online questionnaires and in-person testing.

Featured Clinical Trial for Nonalcoholic Fatty Liver Disease (NAFLD)

A Study of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease And Hyperoxaluria

A Phase 1b, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, 2-Period Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Oral Administration of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease (NAFLD) And Hyperoxaluria
 
Eligibility Requirements:

  • 18 to 70 years of age (inclusive)
  • Have a history of or risk factors for NAFLD (this may include high liver enzymes, obesity, high cholesterol, metabolic syndrome, diabetes or pre-diabetes)
  • Have a history of kidney stones
  • Have a total body weight >50 kg (110 lbs)

All study participants will receive the assigned study treatment, study-related medical exams, and study-related laboratory tests at no cost. Further details about study support can be discussed with the study team.

Visit the trial site to learn more and see if you qualify

The American Liver Foundation receives contributions and funding from clinical trial and study sponsors but does not evaluate or endorse any clinical trials or studies, and is not affiliated with any of the sponsors.

Featured Clinical Trial for Alpha-1 Antitrypsin Deficiency

Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein.

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis

Eligibility Requirements:

  • 18 to 75 years of age, inclusive
  • Not have smoked any substance for the past 12 months
  • Have a confirmed diagnosis of the PiZZ genotype Alpha-1 Antitrypsin Deficiency or be willing to undergo confirmatory testing at screening
  • Not have hepatocellular carcinoma (HCC)

All study participants will receive the assigned study treatment, study-related medical exams, and study-related laboratory tests at no cost. Reimbursement for travel expenses may be available. Further details about study support can be discussed with the study team.

Visit the trial site to learn more and see if you qualify

The American Liver Foundation receives contributions and funding from clinical trial and study sponsors but does not evaluate or endorse any clinical trials or studies, and is not affiliated with any of the sponsors.

Search for Clinical Trials

Participating in a clinical trial is a great way to contribute to curing, preventing and treating liver disease and its complications. Start your search to find clinical trials that need people like you.

  1. Click “START” to begin
  2. On the next screen, enter the name of the liver disease and answer specific demographic data (such as city / distance / age)

By selecting “START,” you will be leaving ALF’s website and accessing your search results on Antidote’s website.  The American Liver Foundation does not endorse and is not affiliated with any of these trials.

Last updated on January 11th, 2024 at 12:21 pm

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