Thousands of cardiac research clinical trials are conducted around the world each year as a way to offer the best and most current health care possible. At Parkway Cardiology Associates, we know that clinical research may help people live longer and feel better. Our clinical research team actively conducts research at our facility and works to match patients to the appropriate trials.
About Clinical Research:
Clinical research is a drug discovery process. Drug development is divided into four phases. Phase I utilizes a small number of healthy young volunteers determining serum drug levels and chemical profiles being drawn on an hourly basis. Phase II trials are used in a population for which treatment is intended, involving less than 1000 patients. After successful Phase II trials, the pharmaceutical company has a good understanding of the safety and efficacy of a drug. Phase III trials build on this knowledge. These trials have several hundred to several thousand patients involving 30 to 100 centers in the United States and throughout the world. Phase IV studies bridge the gab between research and marketing and allow further data collection on the new drug or device. Only after phase I-IV clinical trials are completed to the FDA's satisfaction are these drugs available for the general public. Parkway Cardiology focuses on phase II, III and IV drug trials.
What does this mean to you as a potential volunteer?
Volunteers participate in a clinical trial for many different reasons. People with chronic or life-threatening diseases may seek clinical trials as a way to gain early access to promising new drugs. Some join for the extra attention they receive. Others take pride in assisting with the development of a new drug or device, bringing better health care to our community.
If you decide to participate in a clinical trial, your physician and a clinical research coordinator will speak with you about the trial before you give informed consent. They will discuss with you in an honest, straightforward manner exactly what the protocol involves, the potential side effects, the benefits and the patient¹s responsibility and commitment in the follow-up process.
Participating through Parkway Cardiology Associates:
Parkway Cardiology clinical research department is regularly selected to conduct clinical trials. Our research team includes board certified cardiologists and clinical research coordinators. All of our coordinators are registered nurses with cardiology experience dedicated to conducting clinical trials.
Clinical research protocols are carefully designed to protect the volunteers involved in the research process. The FDA reviews every protocol prior to volunteer enrollment and throughout the trial. An institutional review board (IRB) approves each protocol. The role of the IRB is to ensure that the patient's rights are protected; ensure that the informed consent lists all the information about the trial and to ensure the patient's safety.
The physicians at Parkway Cardiology Associates actively support clinical research. Participation in a clinical trial is always voluntary and declining clinical research will never impact your heath care in the clinic.
If you are interested in learning more about clinical research please contact your physician or call the research department at Parkway Cardiology Associates at 865-482-4078.