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What goes on in the world of idiopathic pulmonary fibrosis (IPF) research?
It takes years, even decades, to start and finish research for any new drug. Each drug goes through many stages and variations of tests ― or clinical trials. This process helps scientists find out if and how a drug helps treat IPF symptoms, how safe it is and how it should be given.
Take a look at the big picture of how new drugs get approved.
It all starts with the scientists. They look at the many ways IPF might cause lung damage and research different drugs that might work for one or more of those causes. After they decide which drug to study, the scientists work in the lab, often with animals at first. They understand how the drug works, how much is needed for it to work and what some of the side effects might be.
Once the drug is found to be safe in the lab, the next step is to test it in people. Each clinical trial is planned so the scientists know what to measure, what to look for and how patients respond.
Phase 1 starts with small groups of people who don’t have IPF. The researchers make sure the medication is safe and find the right dose.
If the drug appears safe, phase 2 tests larger groups of people with IPF. The scientists make sure that the drug does what they thought it would do. They also learn about the drug side effects. Each test takes months to years.
In phase 3, more people with IPF are added to the study and the scientists continue to make sure the drug works safely.
Any new drug must pass all of these phases before the U.S. Food and Drug Administration (FDA) reviews the drug for approval.
If the drug passes all three phases, the results get sent to the FDA. The FDA carefully reviews the results and decides if the drug needs more testing or is ready for patients to take. If the drug is approved for IPF, the drug company can make and sell it. Doctors can prescribe the drug and people with IPF can start using it.
As people with IPF use the drug, the FDA continues to monitor the drug for safety. This is phase 4, the “post-market” phase. The FDA gathers information about the drug’s effect, any side effects and how it compares to drugs already being used for IPF. Any serious adverse reactions are reported to the FDA.
Can I join a study?
To learn about studies that are going on right now for IPF, you can find a list on the IPF Foundation or Pulmonary Fibrosis Foundation websites.
If you have any questions about possible new drugs for IPF, talk to your doctor.
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