The Pulmonary Fibrosis Foundation (PFF) recently submitted research data about more than 1,100 patients who suffer from pulmonary fibrosis (PF) to the U.S. Food and Drug Administration (FDA), in order to participate in the Patient-Focused Drug Development Meeting for Idiopathic Pulmonary Fibrosis. The meeting will take place on September 26 in an effort to raise awareness and understanding about PF’s patients’ needs and therapy demands.
The survey, which was developed by the PFF’s physicians, pulmonary fibrosis leaders, and previous FDA officials, has already been answered by about 1,200 people. “Specific questions posed by the FDA were addressed in the PFF Survey, which will provide important feedback to the FDA,” explained the PFF Chief Medical Officer Gregory P. Cosgrove, MD.
“For example, 25 percent of respondents indicated that they have seen no improvement in their condition based on their current treatment regimen. Insights such as this will help the FDA better assess quality of life issues when evaluating new therapies,” he said. It was also noted that shortness of breath and fatigue were the most severe symptoms (65% and 21%) experienced by patients, and 51% of the patients reported that they are not able to participate in regular sports activities due to the disease’s symptoms.
“We applaud the FDA for focusing its attention on this devastating disease and for recognizing the importance of direct patient participation in this process,” PFF President and COO Patti Tuomey, EdD, said. “We are pleased to be able to play a role and ensure that patients’ voices are heard at this landmark meeting. We wholeheartedly support the FDA’s goal of including patients as an important component in the design and implementation of clinical trials.”
In addition to the questions created to meet the FDA criteria, there are also survey questions aimed to help the PFF understand the needs of PF patients and their families, which are expected to guide the foundation in future programs and initiatives, as they announced. PF patients, their families and caregivers may fulfill the survey until the end of the year.
The FDA’s Patient-Focused Drug Development Meeting for Idiopathic Pulmonary Fibrosis event will take place on Friday, September 26, between 1:00 and 5:00 p.m. EST, on the FDA’s White Oak Campus. The event will also be webcast, and registration for the meeting or the webcast can be found here. The data from the survey will be presented during the event by Dr. Cosgrove, and the results will be posted at the public comments section of the FDA website.
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