HEALTHY LIVING


Clinical Trials: Removing the Luck Factor


Medical studies can provide lifesaving care. Now there are ways patients can more easily access the latest cutting-edge treatments. ::


BY CHARLOTTE LIBOV O


ne day, bob mandell felt really sick. Thinking he had the flu, he got into bed. Suddenly, he


was overcome with a terrible headache. Then he realized his right side was immobile. “I struggled to call


911 and told them ‘I think I am having a stroke,’” he recalls. Not thinking


rationally, which is common after a stroke, Mandell got out of bed, tumbled down a flight of stairs, and passed out. When he regained consciousness, he was in the hospital. Indeed, he had suffered a massive stroke that would forever change his life. “I was told I’d be in a wheelchair


for the rest of my life. I was unable to walk, write, or even think clearly. I couldn’t do anything,” he said. This happened in 1996. Today,


Bob Mandell is 70 and he not only has regained nearly all of his physical capabilities, but he runs two businesses and is writing a book about his stroke experience. The secret to his remarkable


recovery: enrollment in clinical trials that gave him cutting-edge treatment not available to the general public. “By participating in clinical trials I


80 NEWSMAX MAXLIFE | MARCH 2015


got healthcare that was not only free but also innovative,” he says. Clinical trials are research studies


in which patients volunteer to take part. Studies that use human participants are monitored by the U.S. Department of Food and Drug Administration and are the final step before a drug, procedure, test, or device is approved. Although enrollment


A DIFFERENCE Mandell’s treatment included a study.


in a clinical trial can be hugely beneficial, even lifesaving, there has often been an element of luck


involved in becoming a participant. Doctors, unless they are involved in the research, often don’t know about


clinical trials that can help their patients. And even if they do, they don’t mention them. A 2013 poll of seriously ill patients


found that less than a quarter of their doctors had mentioned clinical trials as a possibility. “I saw scores of doctors after my


stroke and the only person who ever said to me ‘You should get into a clinical research study’ was a young physical therapist,’” said Mandell. This means it is often left to


patients to gather information about trials that might help them. This can


TRIAL STAGES EXPLAINED B


efore you enroll in a clinical trial, you should understand the stage the research is in. Simply put, the lower the number, the less proven the treatment. Phase I: An experimental drug or treatment is tested in a small group of people


(20-80) for the first time to evaluate safety and side effects. Phase II: The drug or treatment is administered to a larger group (often 100-


300) to determine its effectiveness and to further evaluate safety. Phase III: The drug or treatment is administered to a large number of patients


(1,000–3,000) to confirm effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the drug or treatment to be used safely. Phase IV: The FDA has already approved the drug or treatment at this point and


it may be available to the public. However, researchers continue to track its safety, risks, benefits, and optimal usage.


DOCTOR/CAIAIMAGE/MARTIN BARRAUD/GETTY IMAGES / MANDELL/COURTESY OF ROBERT MANDELL


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