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What Is an Investigational New Drug Study?

Clinical trials are usually considered to be biomedical or health-related research studies in humans that follow a pre-defined protocol.

By: Duane Blankenship | Category: Health & Fitness | Issue: March 2009

The Options Health Research staff: (Front Row, L to R) Linda Shutts, Sharon Jones, Derrick Weber, (Back Row, L to R) Stacy Goodin, Charlotte Johnston, Lillian Effinger and Alicia Johns.

What exactly is a clinical health trial? Clinical trials are usually considered to be biomedical or health-related research studies in humans that follow a pre-defined protocol. They may be both interventional and observational studies. Interventional studies are those having research subjects assigned by the investigating company to a treatment or other intervention, and their outcome is measured. Observational studies are those in which participants in the study are observed, and their outcomes are measured by the investigators.  

A minority-owned business, Options Health Research was incorporated December 5, 2005. Owners include Sharon Jones, Debbie Langley and Dr. Harvey Tatum. The operation conducts clinical trials with a specialty in gastroenterology studies, including irritable bowel syndrome, Crohn’s disease, ulcerative colitis, diarrhea and constipation.

The company has also begun conducting five new diabetic studies. Other ongoing studies include those for gastro esophageal reflux disease (GERD) and hepatitis C, for patients who are naïve to treatment, have suffered treatment failures, or have been non-responsive to treatment. Other projects include sedation studies and colon prep studies for colonoscopies.

Options Health Research recently conducted a study and evaluation on two preps used prior to a colonoscopy exam, and a study of a hepatitis C device used for testing individuals for the disease. The hepatitis C study was done to determine if the disease could be diagnosed conclusively by swabbing the mouth and gums, if the outcome of tests was altered by the use of tobacco, alcohol, food, dentures or taking medications, and if pregnancy could affect the outcome of the prescribed test for hepatitis C.

You may ask, “Why would I want to participate in a clinical research study?” According to Sharon Jones, “Participation in these studies often leads to FDA approval of new drugs, treatment and innovative health care products that are then marketed to the public. They help contribute to healthier, more productive lives for those participating in the test, for other users, and for future generations. It is one of the most rewarding aspects of working at Options Health Research and participating in the conducted studies.” Linda Shutts, a lab technician added, “Our entire staff is here to help stamp out disease. We are not a free clinic; we are a research clinic.”

Members of the staff agree that they really get close to study participants and their families – most of the work is one-on-one. Studies vary in length from very short term to several years. Many of the participants have nowhere else to turn; for one reason or another, they’ve reached the end of the road in the treatment process, and a clinical study may be their last resort for recovery.

Some participants are referred to Options Health Research by physicians, the Red Cross or the health department, while others respond to the company’s advertising to sign up for their clinical studies. All treatment and evaluation is free to participants, and many receive compensation for their time and travel. Additional medical procedures are also provided free as long as they are protocol driven. The Institutional Review Board (IRB) oversees all studies.

Often a new drug or treatment may be striving to compete against another drug or treatment that has already attained FDA approval. To attain equal status, the new drugs and treatments must undergo rigorous testing and studies that prove, or disprove, their value in the treatment of an intended disease.

There are also drugs that have been tested and approved for one form of treatment that may later be found to also have beneficial qualities for treating other diseases or conditions. Again, that drug or product must be tested and proven in order to gain an additional label of approval before it can be marketed.

For more information on future clinical trials, please contact the Options Health Research office at (918) 513-3476.

For more information, contact

Options Health Research

1145 S. Utica
Tulsa, OK 74104
(918) 513-3476

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Duane Blankenship Profile Picture

About Author Duane Blankenship

Blankenship graduated from the University of Oklahoma and has enjoyed a lifetime career in advertising. He started his own advertising business in 1993 and enjoys creating graphic art and writing. Hobbies include hunting, fishing and pencil drawings. Duane and his wife, Janice, have been married over 50 years and are active in their church and community. He has been a contributing writer for Value News/Values Magazine since 2005.

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