Clinical Studies: Finding Ground-Breaking Treatment

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Category: Research Articles Published on Wednesday, 25 June 2008 Written by Yong Tsai, MD
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Have you ever seen advertisements offering you testing and treatment in exchange for your participation?  Has your physician suggested an upcoming study? A common reaction is "No way, why should I be a guinea pig?"  The truth is, that thanks to millions of patients who have volunteered for clinical trials, countless others, unresponsive to current available treatment, have also benefited with these new drugs and treatment upon their availability to the public.

In the past few years, thanks to rapid scientific breakthroughs, a new era in medicine, particularly affecting autoimmune disease, inflammatory arthritis and osteoporosis has been created.

More powerful drugs such as Enbrel, Remicade, and Humira for rheumatoid and psoriatic arthritis and Fosamax, Actonel, teriparatide for osteoporosis, as well a safer new class of non-steroidal anti-inflammatory drugs such as Celebrex, Vioxx, and Bextra have dramatically changed the way we treat arthritis and other musculoskeletal problems.

The FDA (Food and Drug Administration) requires that prescription and over-the counter medications undergo different phases of regulated testing, such as through clinical trials, prior to marketing it to the public.  Because drug safety and efficacy are of utmost importance for FDA approval, scientific statistical data collected from clinical trials are an essential tool for accurate and effective treatment.

From the sponsor (i.e.: pharmaceutical company), to the contract research organization (assumes certain tasks of the sponsor), investigator, research coordinator, research monitor and to the patient, everyone accepts a defined role and responsibility, yet with a common goal of helping discover the safest, most effective and beneficial treatment possible.

Also involved in the research process is an Independent Review Board, comprised of a minimum of five diversely qualified members, responsible for supervising every step of research activity to ensure compliance with FDA regulations, as well as safety and efficacy.

Most importantly, all medical research involving humans is governed by the World Medical Association Declaration of Helsinki, which states that "the well-being of the human subject should take precedence over the interest of science and society" as well as "the health of the patient will be the first consideration." So, if you're thinking about enrolling in a study, you don't have to worry about being treated like a helpless guinea pig. Also, your consent to participate is voluntary and you have the right to withdraw your participation at any time, for any reason.

The fact is that every process associated with clinical trials must follow detailed rules and regulations, regardless of how recurring they might be.  For without the scrutiny and approval from a regulatory board too many unknowns would exist regarding a drug's safety and efficacy.  After all, it's all about finding the safest and best treatment for the patient.

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