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The Importance of Obtaining Unambiguous Results from Clinical Trials  

Mike Mass, MD

Along with an increasing understanding of any given disease process comes a greater complexity of the possible treatments for it. Both the pharmaceutical companies and the FDA have added stricter requirements as to how they get their information from clinical trials, which places a greater burden on the research investigator. It is critical for all concerned that we learn about the characteristics of any new treatment particularly its safety and efficacy. Those of you who have been in studies will probably remember that there are both inclusion and exclusion criteria that will determine a patient’s entry into any study. This is done to maintain safety and to keep factors, which may falsely influence the interpretation of results, out of the study.

These days many of us have multiple medical conditions and varying treatments that must be considered as the investigators interpret study results. Yet many of these patients are included in studies because it is recognized that this is the reality of life for most of us. Therefore every effort is made to be inclusive unless ongoing therapy directly interferes with the actions or possible side effects of the study drug. At this point it is not reasonable to add yet another study drug into this mix. It would simply create too many unaccounted variables and potential risk to the patient.  As a result, it is generally stipulated that research subjects be enrolled in only one clinical trial at a time. Adherence to any study protocol is critical and often is difficult to maintain. No one is interested in adding any additional factors that could adversely affect any outcome of the ongoing study or jeopardize subject safety.

Posted by Amy Autry Bush Monday, March 2, 2015 4:05:00 PM Categories: Insider Corner

March is a Mysterious Month 

As a little girl, I was intrigued with the proverb that the month of March comes in like a lion and goes out like a lamb, or vice versa, in like a lamb and out like a lion.  At that age, the idea that anything could be predicted a whole month ahead of time – especially something as changeable as weather, fascinated me.  I remember trying really hard to remind myself of what the climate was like at the first of the month so that I could check out the veracity of the prediction, but more often than not, I would lose track of the time and have no satisfaction at all.

Adding to the mystery is the fact of global weather – for example, it was certainly lambish here in Jacksonville at the start of the month, but I doubt the residents of Boston would say the same. So where will that put us in 4 weeks?  Suffice it to say that at the end of the month, somewhere on the planet, it will be one or the other, and all at the same time!

March weather aside, however, many people make a living predicting outcomes for all sorts of things. In fact this time of year, March madness comes to mind – those carefully thought out brackets and office-pools for NCAA college basketball. The National Park service has horticulturists who are providing up to the minute forecasts and updates on the peak bloom event for the Yoshino cherry trees planted around the Tidal Basin in Washington D.C.  Will the Federal Reserve increase interest rates before summer? What in the world will Apple reveal at their March 9th media event? And don’t get me started on horoscopes…..See what I mean?  There really is something out there for everyone.

In the world of medicine, there are predictions as well. Every day we are learning about how we can draw conclusions about future health based on current or past information. And many of those forecasts are invaluable in managing or improving health outcomes. For example, it is well understood that cigarette smoking has a negative effect on overall health, so we can reasonably predict that stopping smoking can decrease the risks of cardiovascular events such as heart attack and stroke.  However, there are people who have never smoked who have had a cardiovascular event. How can we anticipate this in advance in order to predict who is at increased risk and who isn’t? Risk factor calculators are useful in computing this type of information so management decisions are effective. These formulas factor in family history as well as current health status to arrive at an actual percentage number which can inform health professionals on the chances of an individual having a cardiovascular event in the future. Naturally, there are always exceptions to the rule, but odds are this information is worth knowing. Call us today to find out more about risk factors and how you can make your best predictions.  We are betting on YOU!

Posted by Amy Autry Bush Monday, March 2, 2015 11:45:00 AM Categories: Musings