Clinical Research

Interested in participating in one of our clinical trials? Please call Burke Primary Care Department of Clinical Research at 828-391-2040.

During the past three years, Burke Primary Care has offered 14 clinical trials focusing on gout, influenza, diabetes, atrial fibrillation and arthritis. Pharmaceutical companies coordinate specific trials with qualified sites across the country to test the efficiency and safety of the latest drugs seeking FDA approval. Burke Primary Care’s Clinical Coordinator, Robert Keene, manages the clinical trials, while Dr. Martin Gessner, Dr. Keith Smith and Dr. G. Michael Gould serve as Principal Investigators. Researchers are required to follow strict rules that are put in place solely to protect the rights and safety of all study participants. The studies at Burke Primary Care are carefully monitored by regulatory agencies including the FDA, Independent Review Boards, and Data Monitoring Committees to ensure the safety of all study participants.

What Are Clinical Trials?

A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health.

There are different kinds of clinical trials, including those to study: prevention options, new treatments or new ways to use existing treatments, and new screening and diagnostic technique options for improving the quality of life for people who have serious medical conditions.

Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol. (Compliments of the FDA.)

 

Why Is It Important To Participate?

Volunteers are critical in the research and development of new medicines and medical devices. Without clinical research volunteers, improvements to current treatments and medical technologies would not be possible. Many people choose to participate in clinical trials because they may have access to new treatments that could be more effective in treating their condition than the treatments that are already available.

Medical researchers can’t guarantee the overall success of these new medications being tested. The reason to study a new potential medicine or device is to determine if the product is effective and safe for treating a particular condition.

It is only through the participation of willing volunteers that improved medications eventually become available. Clinical research is key to introducing new medicines and treatment options.

 

Are Medical Research Studies Safe?

Researchers are required to follow strict rules that are put in place solely to protect the rights and safety of all study participants. The studies at Burke Primary Care are carefully monitored by regulatory agencies including the FDA, Independent Review Boards, and Data Monitoring Committees to ensure the safety of all study participants. However, it is very important that study participants be completely truthful when entering a medical research study so that the researcher can provide the greatest level of safety for the participants.

It is only through the participation of willing volunteers that improved medications eventually become available. Clinical research is key to introducing new medicines and treatment options.

Clinical Research Principal Investigators

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