How safe are clinical trials for cystic fibrosis?
Nothing is more important than safety in developing new cystic fibrosis treatments. There are four layers of protection in every clinical trial for cystic fibrosis. Each trial must be determined as safe and appropriate for patients by 1) the CF Foundation, 2) the FDA, 3) the participating hospital or university’s Institutional Review Board (IRB), and 4) the Data Safety Monitoring Board (DSMB). The IRB is usually made up of doctors and the general public. They look at the trial’s protocol (a clear and detailed plan of the experiment) to make sure that participants’ rights are protected and the trial does not cause them unnecessary risk. The DSMB is an independent committee of experts in cystic fibrosis care that checks information on ongoing trials, watching for possible problems or unwanted side effects. The CF Foundation is the only voluntary health organization to organize a DSMB whose members are experts in cystic fibrosis and completely independent and not involved in any way with
