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De-mystifying clinical trials…… 


There are several phases of clinical trials, and it is useful to understand the process and progression. Here is a breakdown of the basics, although there are exceptions and overlap when it comes to final trial design:


Preclinical studies involve laboratory and/or animal investigations of a potential new drug or treatment.  Mode of action and safety are tested extensively before a new drug is approved by the FDA to begin trials in humans.


Phase I trials involve the testing of a new drug or treatment in a small group of people (18-20) for the first time to evaluate safety, determine a safe dose range, and identify side effects. Participants in these studies are often healthy individuals. Phase I studies typically involve a lot of evaluations, tests and monitoring.


In phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if the therapy is effective, determine best dosing regimen, and to further evaluate safety. Often these are individuals with the particular diagnosis that the drug or treatment is targeting. Phase II trials continue with close monitoring and can also involve lab tests to measure how the investigational drug is metabolized over specific time periods.


Phase III trials are designed to enroll an even larger group of participants (1,000 to 3,000) to confirm effectiveness, monitor side effects, compare it to commonly used treatments, and collect data that will allow the drug or treatment to be used safely. These trials are often placebo-controlled and include patients with other medical problems and medications. Outcome studies typically involve many thousands of subjects over several years to evaluate the end results of a treatment in terms of illness or benefit to society.


After a drug or treatment has FDA-approval, Phase IV trials are conducted to collect additional information, including risks, benefits and optimal use. These are also known as Post-marketing trials.

Posted by Amy Autry Bush Thursday, January 16, 2014 2:33:00 PM Categories: Insider Corner

Dr. K's Corner 

Can you trust the media for medical advice?

Patients often ask me my opinion about some medical information that they’ve heard about on TV, radio or the Internet. In fact, not infrequently, when they question me about what they heard, they have already acted on the advice.

So I now pose a question, in turn, to our Encore community. Do you think it’s a good idea to trust the media and take action on important health care decisions?

In two recent examples, I’ve had several patients stop statins because they heard these drugs “were bad on Dr Oz” and other patients quit fish oil supplements because they read an article by Zorba Pasteur casting doubts about their effectiveness. Were these decisions wise? Probably not.

In the first case, I didn’t see the show in question. However, I can assure you that in patient with heart disease or at very high risk, statin drugs, without doubt, reduce heart attacks and save lives. They accomplish this task with minimal side effects, contrary to sensationalized information circulated in the media. On the other hand, an honest debate exists about the benefit, or lack thereof, of statins in healthy folks over a long period of time. If the Oz experts were indeed experts, they may have expressed their skepticism about the use of statins in completely healthy people, but certainly, they could not argue against the proven benefits in those of us with heart or vascular disease or at very high risk.

In the second case, I read the article, which referred to a research paper that combined many studies and found that daily fish oil supplements overall don’t do a whole lot for healthy folks. But again, the article did not address the specific benefits to high risk patients such as those who had a recent heart attack or very high triglyceride levels.

Understanding risk is a key concept in medicine and why we should view most media advice with skepticism. Talking heads on TV or an Internet sales piece cannot possibly know your individual situation. So, for the most part, media advice should be ignored. Now of course, if the media announces that the Food and Drug Administration has ordered a drug pulled from the shelves for an unexpected complication, we should take heed. But, by and large, media advice should not change medical treatment without a medical consultation. In fact, taking this advice can have terrible consequences. Last week I treated a patient who stopped blood thinning medicine after she heard a negative commercial about the drug. A week later she suffered a major stroke.

Posted by Amy Autry Bush Wednesday, December 26, 2012 8:21:00 AM Categories: Insider Corner
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