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Come spend the night at JCCR! 

An interview with Tanya B.

Tanya B. is not afraid of new experiences. In fact, even though she had never been involved in clinical research, she had no reservations about spending the night at JCCR...she thought to herself, "I live alone. I don't have too many responsibilities"....

It all started with a phone call. Tanya saw a television ad for cardiovascular disease research and scheduled an evaluation with study coordinator, Gail Lowe. When she did not meet the exact criteria for that particular program, Gail recommended that she be evaluated for a congestive heart failure study involving a period of overnight stays in the new Phase I unit at JCCR.

Tanya, a youthful looking, grandmother of three, sat down with me recently to describe her experience with our center and the Phase I program.

She related to me how she has a strong family history of heart disease, but even after suffering a heart attack herself seven years ago, she never really took her health care seriously - taking her prescribed medications only sporadically. Her progressive heart disease, however, was debilitating and "depressing". She was frequently hospitalized for symptoms relating to heart failure and high blood pressure episodes. It wasn't until she was admitted with pneumonia that she finally began to "connect the dots" between her lifestyle and her health. She started to take her health seriously, beginning with her medications and then started to research and read about cardiovascular disease.

So, Tanya came into JCCR with a good basic knowledge of her cardiovascular disease and the professionals on staff helped her to connect the dots even further by explaining the role of research in finding new therapeutic approaches to congestive heart failure and improving cardiovascular outcomes. Because the program is funded by a sponsor grant, there is no cost to participate and all of the preliminary screening tests are free.Tanya received multiple echo-cardiograms, a colonoscopy and a mammogram in preparation for her clinical trial. All along the way, the process was explained and the objectives were outlined.

Her favorite part of the eight-night program was that she didn't have to prepare any meals! All were provided for her - breakfast, lunch and dinner. She also liked the peace and quiet, although she was allowed visitors. Frequent attention from the staff and close monitoring from the physicians made her feel comfortable and confident.

Tanya admits today that she enjoyed participating in the Phase I program and would encourage others to do the same. "Educate yourself and learn the objectives". In other words, come spend the night at JCCR!

Posted by Amy Autry Bush Monday, April 6, 2015 8:29:00 AM Categories: Insider Corner

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
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