Drug Clinical Trials Focus on Efficacy Over Quality of Life
The clinical trials that lead to new drug approvals or expanded indications are quick to praise a therapy’s clinical benefits, such as longer survival or time to progression, but only about one in five of those trials find improvements in patients’ quality of life (https://doi.org/10.1001/jamaoncol.2022.0864) (QOL), researchers reported (https://doi.org/10.1001/jamaoncol.2022.0864) in JAMA Oncology.
The researchers evaluated 45 phase III randomized, controlled trials that represented 24,806 participants. Of those, only 11 (24%) reported improvements in global QOL (https://doi.org/10.1001/jamaoncol.2022.0864), and the researchers found that those trials were also more likely to show improved overall survival rates. Six trials reported declining QOL (https://doi.org/10.1001/jamaoncol.2022.0864), and 34 could not demonstrate improved QOL in patients receiving the experimental agent compared with controls. However, the researchers noted that 16 (47%) of those 34 trials reported the lack of improved QOL in a positive perspective, “an observation statistically significantly associated with industry funding.”
“Progression-free survival was not intended to inform clinical practice or establish whether a new therapy provides clinically meaningful benefits for patients,” the researchers wrote in a corresponding commentary published in Lancet Oncology (https://doi.org/10.1016/S1470-2045(22)00015-8). “However, over the past two decades, it has become the most common primary endpoint in oncology clinical trials. We are deeply worried about how the term survival in this phrase can influence clinical practice and patient choices. We propose replacing the phrase progression-free survival with a less ambiguous term: progression-free interval.”
Oncology nurses can help patients understand the full implications of their therapy options, including the effects on both clinical outcomes and quality of life, so they can make informed treatment decisions.