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Megan Perez and Trudy Madan Discovering Tomorrow's Medicine Written by: Megan Perez and Trudy Madan
Issue: November 2010 | NSIDE Medical
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The impact of clinical research

Discovering medicine is like discovering gold. Not in the sense that gold and medicine are both exceptionally profitable – of course they are; but once one looks beyond the potential capital of medicine itself, there lies a different realm of meaning. Forget the clichés; shed the controversies of medical practices from your mind; get down to the heart of both medicine and practice; and think about what it means.

Medicine and health care are necessities that our national and global society depend upon, want and need without a doubt. Once the floodgates to discovering medical treatment and supplements are opened in today's world, there are bounties of endless opportunities for exploring a range of diverse and complicated illnesses. This opens up an aperture for findings in a particular sector of a specific illness or disease. For example, 7.8 percent or 23.6 million Americans have diabetes. In fact, diabetes was the seventh leading cause of death in 2006, according to the American Diabetes Association.

Raw facts like these are exposed and digested by physicians, some of whom chose to pursue and develop an effective treatment for an illness such as diabetes. They do so by specifically shaping the medicine for a person with diabetes, but at the same time making the medication distinctively different from other drugs on the market today. So in theory, this process only leaves room for improvement and opportunities for scientific breakthroughs in treating such diseases.

According to the American Diabetes Association, or ADA, below are the percentages of people diagnosed with diabetes over the age of 20 in a 2004 to 2006 national survey. Susceptibility to diabetes varies by race and ethnicity. For example:

• 6.6 percent of non-Hispanic whites
• 7.5 percent of Asian Americans
• 11.8 percent of non-Hispanic blacks
• 10.4 percent of Hispanics

As a result of these kinds of findings and statistics by reputable organizations like the ADA, clinical research is adapting and modifying how its contributors investigate or go about treatment for specific races that are most susceptible to a given disease or illness like diabetes. Thus, the medicine undergoing research today is capable of being uniquely personalized for the people most at risk, and for that reason, clinical trials are essential.

Understanding that clinical research is around to help us rather than hurt us is crucial. Clinical research is a professional business made possible by establishments and partnerships with both physicians and major pharmaceutical corporations. It is also recognized by the government and the FDA as an essential process of any medication or medical treatment.

In clinical research, there are phases and procedures each drug has to pass through to even be considered a medication worthy of human exposure. By the time the drug or treatment reaches this position, it has gone through vigorous initial courses of action taken by the physicians. The drug is then evaluated by its effectiveness on a specific person or group of people – all of whom have to meet a certain criteria, as well as fit the model of an individual who would actually use the drug for treatment.

In this case, the medicine would be specific to ethnicity and would require the accumulation of anthropologic data of individuals in order to cater to the cultural differences in these groups. It is important that the criteria are made specific so the drug is able to target certain subgroups of people.

While all of this explicit data is taken into consideration, the research and findings of the studies better not only the drug being evaluated, but also other medications and treatments in the works. The FDA recognizes these important steps in clinical research, and therefore, "recommends using a standardized approach for collecting and reporting race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA-regulated products."

The government has issued these guidelines of recommendation for both the "applicant" patient, as well as for the physician, so there is a "standard approach" to these exclusive clinical trials, and an effective mean to recording and accounting for such data. Once the medical treatment on the particular individual or group is complete over the given time frame, the clinical research segment is over. The results are either a pass or a fail depending on the results, which record the effects of the medication on patients. If the treatment is proficient in all areas, it is then available to pharmaceutical companies to distribute.

None of these highlights on improving and personalizing medicine would be possible without the presence of clinical research. Clinical research requires many spheres of professional collaboration for it to work, and therefore, continue to thrive in the workforce as a region of continual growth and development. It also continues to lead our global nations to more medical advancements, and as a butterfly effect, a healthier global community.

Trudy Madan, MHA, is the CEO of Synergyst Research and Discovery Clinical Trials. Synergyst Research contracts with physicians to assist with administrative duties and increase clinical research studies. In 2009, Synergyst Research negotiated more than 150 research studies in all specialties. Please visit us online at www.synergystresearch.net.

Discovery Clinical Trials partners with physicians to create research centers within private practices. In 2009, Discovery Clinical Trials created eight research center partnerships with physicians across the United States. Please visit us online at www.discoverytrials.com. For more information, e-mail trudy@synergyst.net or call 210-447-2080.

Clinical research is a professional business made possible by establishments and partnerships with both physicians and major pharmaceutical corporations.

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