Clinical Trials Education Center
What is a clinical trial?
Clinical trials for pulmonary fibrosis (PF) and interstitial lung disease (ILD) treatment are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans.
Is it safe?
Clinical trials follow strict scientific standards to protect patients. The informed consent process prior to enrolling in a trial gives clear information on the expectations during the study, the risks, and the benefits. An institutional review board (IRB) oversees studies to make sure they are safe, fair, and protect people who take part. You can leave a trial at any time.
Why should I participate?
Participating in a clinical trial is one of the most powerful ways to volunteer for the quest for new treatments. By participating, you’ll be contributing to medical advancements that can benefit future generations. Clinical trials are essential in the quest for new treatments because they’re the only way for researchers to find out if a potential new treatment is safe and effective. During the trial, participants may obtain access to a potential new PF medication and receive valuable education about improving their health. Increased clinic visits and testing, usually associated with a clinical trial, may also give the participant a clearer picture of the state of their disease.
What happens during a clinical trial?
Clinical trials often have four phases or testing periods. Each phase has a specific purpose, and researchers seek new volunteers for each phase. The four phases are below.
Phase 1
Researchers test a new drug or treatment in a small group of people (usually 20-100 volunteers) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Doses start small and increase in different patient groups until the desired effect of the treatment is observed or side effects of the treatment become too severe.
Phase 2
The drug or treatment is given to a larger group of people (up to several hundred volunteers) to see if it is effective and to further evaluate its safety. Most Phase 2 studies have randomized control (placebo) groups and treatment groups. Most of these trials are “double-blind” which means that neither the patients nor the researchers know whether the patient is receiving the treatment or placebo.
Phase 3
The drug or treatment is given to large groups of people (several hundred to thousands of volunteers) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments (or placebo), and collect information that will allow the drug or treatment to be used safely. Phase 3 trials are also randomized and most are double-blind.
Phase 4
The drug or treatment has been FDA approved for marketing. These studies can include post-market requirement and commitment studies that are required of or agreed to by the study sponsor. Phase 4 trials gather additional information about a drug's safety, efficacy, or optimal use.
Find a trial near you
Want to see if there are any active PF or ILD trials near you? Use the interactive Google Map! Type in your zip code to find trials in your area. Once you find one, you can click “see details” for more information.
Clinical Trials of the Month
Each month, the PFF highlights trials actively recruiting in our Clinical Trials Blog. Check it out to see monthly highlights, new resources, research updates, and patient stories.
What clinical trials for PF are currently underway?
Researchers are making great strides in the search for new treatments for PF and ILD. We have an interactive tool, the Drug Development Pipeline, that allows you to see the latest progress in drug development.
The PFF Community Registry
The Pulmonary Fibrosis Foundation is leading the fight by funding promising research and we need your help.
One of our key research programs is the PFF Community Registry. We invite eligible participants to join by completing a series of simple surveys. Your survey responses will be used by researchers to better understand how PF and ILD progress over time, respond to treatments, and how the diseases affect individuals. The more individuals who join and provide responses, the closer we come to a cure.
Eligible participants include:
- Patients living with PF and ILD
- Lung transplant recipients who have had PF or ILD
- Caregivers and biological family members of patients with PF or ILD, including those who have passed away
Enrolling in the PFF Community Registry is entirely online. All you need is internet access. Learn more about this groundbreaking program by visiting the PFF Community Registry homepage.
