Piedmont Endocrinology has participated in multiple clinical research trials, including diabetes management studies, hypothyroidism research, and testosterone safety trials. However, through our new partnership with Lucas Research, we believe we can do even more. Lucas Research is one of the top clinical research organizations in the country, and they bring a wealth of experience in clinical trials with a 96% study patient retention rate and a 90% study completion rate. Pharmaceutical companies coordinate specific trials to test the efficiency and safety of the latest drugs seeking FDA approval. Our Principal Investigators are Dr. Donepudi and Dr. Barber, and their guiding principle is to ensure the rights and safety of all of our study participants. In addition, to further enhance study participant safety, the studies in which we participate are closely monitored by multiple regulatory agencies including the FDA, Independent Review Boards, and Data Monitoring Committees.
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.