In 1992, the United States Food and Drug Administration, the federal government agency over the approval of all pharmaceutical drugs, including their clinical testing, came out with the accelerated approval program, a scheme for bringing drugs to patients’ hands many years more quickly than waiting for clinical trials to be completed, which can leave patients waiting their entire remaining lives just for the drugs they want to try to fix their health problems with, and that’s if they’re even approved.
Although the accelerated approval program isn’t designed for any one health condition, such as Parkinson’s disease or the broader family of end-of-life neurological conditions, most uses of the accelerated approval program involve trying to bring experimental cancer treatments to both patients and cancer doctors – oncologists – alike.
Since you probably don’t know much about how the accelerated approval program works, it’s important to understand what a surrogate endpoint is and how it’s used in this FDA program.
Surrogate endpoints are not conclusive signs that treatments work, though they are – more or less – stepping stones researchers can take in determining whether treatments are successful or not. These markers and metrics can come in handy, though they shouldn’t be leaned on. The bad thing about these surrogate endpoints is that they are far from being considered reliable.
Such risks are worth taking when no other treatment options are available for people who have especially severe cases of cancer or other unique diagnoses that are ultimately going to result in major chances of early death, if a premature death isn’t already guaranteed.
A study published earlier today, on Tuesday, May 28, 2019, in The Journal of the American Medical Association titled “Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval” came to the conclusion that just 20-some percent of drugs used to treat cancer that had been approved through accelerated approval from the U.S. FDA using the aforementioned surrogate endpoints ended up boosting the survival rates of cancer patients in trials conducted after using such experimental cancer drugs known as confirmatory trials.
The study, which was primarily authored by Dr. Bishal Gyawali, a practicing physician specializing in oncology and assistant clinical professor at Canada’s Queen’s University, found that just 19 of 93 cancer drugs that got approved through the FDA’s accelerated approval program ended up improving patient survival likelihood at all.
Read More: https://edition.cnn.com/2019/05/28/health/cancer-drugs-fda-accelerated-approval-studies/index.html
Dil Bole Oberoi
