This case-control registry study in Denmark found that novel anticancer therapies seemed to be tested on a socially selected group of patients with cancer. Patients with long distance to the Phase 1 unit, less education, and belonging to the lowest income quintile were less likely to be referred to Phase 1 trials. (PubMed)
Will the FDA update the IND pathway?
The U.S. FDA has initiated a review of its Investigational New Drug (IND) application process whereby researchers are permitted to begin clinical trials in humans. Depending on the results of this review, the IND application process may be changed, especially if the study uncovers widespread safety concerns. (Modern Healthcare)
Off-label use of drugs based on flimsy evidence
Clinical trials that explore the repurposing of drugs for off-label uses are common, but without a commitment to rigorously testing the hypotheses generated by these exploratory trials, drugs used off-label are costly and may be ineffective. Ethics committees should devise measures that encourage coupling of exploratory testing with confirmatory trials. (British Medical Journal)
Phase 1 pediatric cancer trials are therapeutic. True? Or, is this “a noble lie”?
It’s this author’s view that it may be a mistake to think of early phase trials as having a therapeutic impetus. U.S. regulations require that, when we enroll children, we view phase 1 trial participation as therapeutic. However, a recent meta-analysis concluded that phase 1 trials in children cannot generally be presented as having a therapeutic risk/benefit. Thus, phase 1 trials in children cannot be reconciled with research regulations. (translationalethics.com)
More patients are joining Phase 1 cancer trials – to get access to new experimental treatments
The importance of early stage clinical trials in oncology is increasing. Historically, cancer patients participated in phase 1 trials because this was the only option for those with advanced cancer that would not respond to standard treatment. Today, more patients are interested in participating not because it is a last resort for them, but because they gain access to new treatment alternatives to chemotherapy, and there are larger trials which benefit more patients. (SCIENMAG)