It takes additional time to enroll participants and to process and analyze the results of each phase. Please note that the length of time refers to the time it takes to participate in a trial, not the entire length of the phase. The infographic below shows a breakdown of the questions that researchers try to answer, the number of participants needed, and the length of participation for each phase of research. If the FDA approves the drug, researchers will continue to monitor for safety and effectiveness in what is known as a Phase 4 study. Food and Drug Administration (FDA) and become available to the public, it must pass through three phases of interventional clinical trials to show that it is safe and effective in treating the disease. The Four Phases of Clinical Researchįor any new drug to receive approval by the U.S. Clinical trials for a new drug will usually start in adults 18 years and older before moving down to younger age groups. To reduce the risk for younger kids with CF who participate in a trial, drugs must first be shown to be safe and effective in adults with CF. Drugs work differently in kids than they do in adults. Those who do not have that bacterial infection would be excluded from the trial.Īnother example is the age requirement for a trial. For example, if researchers are testing how well a particular antibiotic works in fighting Pseudomonas aeruginosa, then the trial would have inclusion criteria specifying that only people with CF who are infected with that bacterium can join the trial. The criteria depend on the type of trial. These criteria exist to ensure that the trial results are accurate and useful, and also to protect participant's safety. In a blinded trial, researchers will not know which participants are receiving treatment and which ones are receiving a placebo.Īll clinical trials have guidelines about who can join, known as inclusion and exclusion criteria. Randomization involves assigning participants to these comparison groups by chance, rather than choice. The other half receive a placebo, which contains no medication. In many clinical trials that test the effectiveness of a medication, half of the participants receive the medication in question. Randomization helps ensure that researchers don't introduce bias into the trial.Researchers can avoid bias by designing a study in a certain way: ![]() The doctors might not even realize they are doing this, and it could affect trial results. For example, if doctors could choose which people to assign to comparison groups in a study, some might assign sicker people to the treatment group and healthier people to the placebo group. Each investigator follows the same protocol to ensure that the study is conducted in the same way at each participating center.īias refers to human choices or other factors (unrelated to the protocol) that might affect a trial's results. Once a protocol is approved, the sponsor chooses principal investigators to run the trial. The protocol must go through many layers of review before a study can begin. What medication and dosages participants will receive, if appropriate.What tests participants will get and how often.While designing a protocol, sponsors often work with the Foundation to get feedback from research experts and people with CF. The trial sponsor, often the pharmaceutical company that develops the therapy or medication, designs the protocol for the clinical trial. A protocol is a plan that explains how the trial will work, what will be done during the trial, and why.
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