Option: Clinical Trial

Researchers conduct clinical trials for the purpose of evaluating the safety and effectiveness of investigational drugs.

Dr. Harvey A. Tatum, gastroenterologist at Hillcrest Medical Center, specializes in the evaluation and treatment of digestive and liver diseases, endoscopies, and consultative services. He is involved in a clinical research study seeking new treatment options for inflammatory bowel diseases that have poor or difficult treatment choices.

Researchers conduct clinical trials for the purpose of evaluating the safety and effectiveness of investigational drugs. Those drugs that are found to be both safe and effective may then be recommended and become available for doctors to prescribe. If a drug under investigation is determined to be unsafe or ineffective in the treatment, the trial results may still be useful for scientists and the advancement of medical research.

In a clinical trial, investigational drugs are often compared with drugs that are already approved or with placebos to assess the safety and effectiveness of the test drug. One who participates in a clinical trial may be assigned to take investigational drugs of varying strengths, approved drugs, placebos, or a combination of these.

The first three phases of a clinical trial are defined by the following: During Phase I, researchers test an investigational drug for the first time in humans by giving it to a small number of healthy people to evaluate its safety, determine the safe dosage range, and identify any side effects that may occur from taking the drug. During Phase II, the investigational drug is given to a larger number of people who have a particular disease or condition to determine the drug’s effectiveness and further evaluate its safety. During Phase III, several hundred to several thousand people with the appropriate disease or condition participate in the trials. Investigational drugs undergo additional testing to determine their safety and effectiveness, to monitor side effects, and to compare them to commonly used treatments.

Dr. Tatum is involved in Phase III research with Osiris Therapeutics, Inc., a Maryland-based company that is conducting a Crohn’s disease study involving the use of stem cells to be used in products for the treatment of ulcerative colitis and Crohn’s disease, both of which are inflammatory bowel diseases. The stem cells are derived from human bone marrow, voluntarily donated by healthy adults between the ages of 18 and 30. The cells in the final product are from healthy adult volunteer donors and not from a fetus, embryo or animal. The final product is administered into a vein of the patient, similar to receiving a blood transfusion. One of the beauties of the new product being tested is that it may be given from man to woman or woman to man and to any blood type.

“We are in need of new therapies for hepatitis C and Crohn’s disease,” says Dr. Tatum. “Many of the people with these diseases do not respond to traditional treatment.”

All of the research performed by Dr. Tatum and Options Health Research takes place in a comfortable office setting. The testing is coordinated with the patient’s primary care physician, and all patient information is strictly confidential.

There are certain requirements for eligibility to participate in a clinical trial based on factors such as age, gender, the type and stage of a disease, previous and current treatments, and other medical conditions. Medical insurance is not required to participate in clinical trials or to receive study-related medical care and services. It is all provided at no cost to the participant.

If you or someone you know is eligible and decides to participate in the clinical trial, an informed consent document will be provided including information about the clinical trial and what you can expect as a participant, as well as potential benefits and possible risks associated with the research.

Call (918) 513-3472 for more information.

For more information, contact

Options Health Research

1145 S. Utica

Tulsa, OK 74104

(918) 513-3472