An Average Patient In A Clinical Trial Isn’t An Average Patient In Real Life. And That’s A Problem.
Those who sign up for clinical trials tend to be younger, whiter and healthier than other cancer patients, which is causing a dissonance between the success of a drug in trials and its success in real life.
Cancer Clinical Trials Often Exaggerate Real-World Benefits Of Drugs
The point of cancer clinical trials — in which some volunteers take the experimental drug, others receive standard care with existing drugs, and the groups are compared on measures such as whether their tumors shrink, how long they go before tumors return, and how long they survive — is to see whether a drug is safe and effective enough to be sold to American patients. The whole process rests on the premise that the trials give an accurate indication of safety and efficacy among cancer patients in general, not only those who are eligible for and selected for the trial. (Begley, 11/21)
In other news —
The Baltimore Sun:
Hopkins Works To Shorten Time Needed For Drug Approvals
A federal approval for a new drug can take a decade or more, but researchers at the Johns Hopkins University are studying a way to shave years off the process for medications designed for serious outbreaks of flu, Ebola or other infectious diseases. The researchers want to conduct trials in emergency rooms where large numbers of people sick with these sometimes deadly diseases often end up. The doctors are poised to launch a trial run at Hopkins during the coming flu season — and using already approved antiviral drugs such as Tamiflu — to show volunteers can quickly and properly be pooled in such environments. (Cohn, 11/20)