Writing on StatNews.com, cystic fibrosis patient Ella Balasa says her low FEV1 is excluding her from clinical trials for life saving CF drugs.
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Balasa writes: “Most cystic fibrosis studies, including Phase 1, 2, and 3 trials, require participants to have an FEV1 of at least 40%. Mine is 25% which, for more than 10 years of my life, has made me ineligible for clinical trials. I’m not alone.”
She points out that the FDA, with advice from the CF Foundation, sets requirements for participating in clinical trials to protect the safety of participants. But she questions the need to exclude patients with FEV1 < 40%, suggesting that it could be due to manufacturer concerns over potential results.
Patients “with more scar tissue and lung damage probably won’t achieve the same level of symptom relief and disease reversal as those with milder CF. And they may not experience a significant change in lung function, which means fewer positive results for the company to present to the FDA when seeking approval for a new drug,” she writes.
The FEV1 >40% requirement “tends to lead to trials that include a disproportionate number of younger participants,” she added, and called for it emphasis on other biomarkers when considering enrollment.
“I believe that FEV1 alone is an insufficient proxy for identifying candidates for cystic fibrosis trials. It should be just one of many factors that indicate an individual’s overall health with CF. Considering potential participants’ quality of life and overall health is a reasonable adjustment to current inclusion and exclusion practices,” Balasa writes.