Clinical Research at Advanced Healthcare

with Eugene Monroe, M.D., Dermatologist and President of Advanced Healthcare

Last Updated: Nov. 1, 2003

On “Star Trek,” passing a device resembling a remote control over the inert body of a crewmember enabled the medical team to quickly diagnose and painlessly cure a range of maladies.

The “tricorder” hasn’t jumped from the small screen to the doctor’s office just yet. But the road to quicker diagnosis and low-impact treatment is paved one medical study at a time, and each involves patient volunteers and doctors willing to double as scientific investigators.

Eugene Monroe, M.D., Dermatologist and President of Advanced Healthcare "Research takes place in order to get science advanced, but it's an equal priority to protect the people in the study."

At Advanced Healthcare, countless patients, along with more than 40 trained physician investigators and 15 clinical study coordinators have, to date, participated in more than 300 clinical research studies. By doing so, they hasten the arrival of new and often revolutionary treatments for everything from migraines to arthritis.

Benefits to participants
There are multiple advantages for patients who elect to volunteer, said Dr. Eugene Monroe, president of Advanced Healthcare. Dr. Monroe, a dermatologist, is currently the lead investigator of several Phase III studies of drugs to treat people with psoriasis, atopic dermatitis, hives, acne, rosacea and toenail fungus.

“In general, they get free medication, free exams and have the opportunity to gain access to potentially promising drugs long before they are approved for the marketplace,” he said. Some studies reimburse patients between $25 and $30 per visit for their time and effort.

Among the studies currently in progress at Advanced Healthcare are testing a new form of inhaled insulin which could replace injections for diabetics, and looking at a unique treatment for psoriasis – a weekly subcutaneous injection which impacts the immunologic basis of the disease. The results of a recently completed study involving a subcutaneous injection for obesity are now being assessed.

The trials in which Advanced Healthcare personnel and patients take part are carefully designed studies comparing investigational or already approved drugs to a placebo (inactive product) or another approved drug.

Study participants are contributing to medical research that may help other people suffering from the same disease. But, Dr. Monroe emphasized, many of the drugs tested never make it to the market. Citing the obesity study, he said that while preliminary results appeared to be encouraging, there also was some concern that patients developed a resistance to the drug over time. The final results of the study, he said, are yet to be determined.

Before signing on to a study, patients are given a consent form listing in detail the length and scope of the study, and the potential risks and benefits. The consent form is reviewed and approved by independent agencies. It’s done, Dr. Monroe said, in the interest of patient safety.

One standard clause in a research study consent form, Dr. Monroe said, is that the patient can drop out at any time during the trial, for any reason, without having to explain his or her reasons for doing so.

Research phases
The journey taking a new drug from pharmaceutical laboratory to pharmacy counter is a four-phase process. Once the FDA approves the initial process, a very small Phase I study is conducted to determine whether the drug is safe enough to be tested more widely.

Advanced Healthcare’s participation is generally limited to Phases II and III of the process. Phase II studies are generally conducted in between one and three sites around the country and generally include about 100 patients.

The objective is to see whether or not the drug or treatment lives up to its promise. If it does, the study proceeds to Phase III, in which researchers are looking for statistical analysis to prove the safety and effectiveness. Generally the number of sites is expanded to about 30, and 1,000 patient volunteers are sought.

After drugs are approved by the Federal Drug Administration (FDA), Phase IV studies are often done to study specific marketing or medical issues.

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