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THE WEIRS TIMES & THE COCHECO TIMES, Thursday, April 26, 2012
NOT ENOUGH WOMEN PARTICIPATE IN CLINICAL TRIALS
by Terry Stubbs. MA. CCRC
Contributing Writer If you have been read-
ing and listening to the media lately you may have heard that most of the data gathered in clini- cal trials in the United States still comes from Caucasian men. Female
data collected represents less than 25% of the data worldwide, gathered for the development of new drugs. Since men and women
differ in a many ways, it is logical to understand that women may not respond the same way a man does to certain medications. For these reasons it is
important that more data is collected on Women. There are many trials over the past 10 years, which have been collecting fe- male data from nurses working within hospitals. However, we are still lag- ging behind with infor- mation from the general population of women. More knowledge is now
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being collected during clinical trials than ever before. Besides studying the effects of new medi- cations, or the compari- son of already approved drugs, other data is gath- ered about the disease and how it affects each individual participant. Frequently, information is gathered regarding the
participant’s quality of life (how do you feel today) who is suffering with the disease being studied. How does the disease in- terfere with daily living? Information that can help researchers understand more about how women feel and respond to possi- ble new treatments for the future, is also compiled. Knowledge that is now
being used for standard care treatments for low Vitamin D levels originally came from a trial that ran over 20 years ago. Dur- ing that trial for women who were diagnosed with osteoporosis, a non- stan- dard test for Vitamin D levels was being used to measure blood levels of women who participat- ed. It was noticed during this trial that 90% of the women in New England had low vitamin D levels. Calcium taken without enough Vitamin D in the body cannot be absorbed correctly. Hence, the de- sign and development of supplements that contain both Calcium and Vitamin D together were invented. When someone partici-
pates in a trial all infor- mation is keep strictly confidential when it is col- lected by assigning num- bers to each participant in place of names for all data collected. Many lives had been changed for the better and the quality of life increased through data gathered in clinical research studies.
Terry Stubbs MA,CCRC
is the President and CEO of ActivMed Practices & Research
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