Sirven: The Ups And Downs Of Clinical Trials

By Dr. Joseph Sirven
July 17, 2014

Dr. Joseph Sirven

Clinical trials are critical to the success of new drugs. The findings can help people manage disease. Here’s KJZZ Commentator Dr. Joseph Sirven.



Have you or a loved one been faced with a disease or health problem that’s not curable with available medications?  You may have been asked to participate in a clinical trial. These trials are for an unproven drug that might improve or even save your life. All the money, time, and effort spent on research for new therapies depend on your agreeing to participate.  Yet, the lack of willing patients is causing a huge problem.

Eighty percent of American clinical trials are behind schedule because of low numbers. It doesn’t matter what condition — Alzheimer’s, cancer, anything — few folks want to get involved. Without these pioneering patients, that novel treatment goes away because no one knows whether it will work, and restless investors can’t afford to wait and take their money elsewhere.   

So why the hesitation? Drug trials often involve flipping a coin between treatment or a sugar pill, without the doctor or patient knowing which one they’re taking. No one wants to be a “guinea pig.” Yet, clinical safety is probably higher in these studies because of the numerous laws protecting research enrollees from harm.

Even so, those laws can run amok. I remember vividly meeting a patient who I wanted to offer a clinical trial for something I truly believed could help. I composed a brief consent form but after our institutional lawyers got involved, it ballooned to 25 pages of legalese. My patient turned down the trial and I found my business card torn up in the hallway outside my exam room as that family literally ran scared out of my building. I can’t blame them.

Here’s the thing: We can’t have it both ways. We can’t demand new treatments, assuming someone else has tried them first.  If we ever expect to find a cure for any number of horrible diseases, we have to step up. No one chooses to be sick but sometimes these illnesses choose us. If our time is called to participate in a research study, it’s time to be the hero. Many lives could literally depend on it.

Dr. Sirven is a KJZZ commentator and the Chairman of Neurology at the Mayo Clinic