About Clinical Trials
Wake Forest Baptist Medical Center (WFBMC) conducts hundreds of clinical trials every year in an effort to detect, treat and prevent disease. Clinical trials conducted at WFBMC are managed by professionals, including an MD or PhD faculty with specific expertise in the disease area, who have research experience.
Before a clinical trial can begin at WFBMC, it must go through a rigorous review process conducted by the WFBMC Human Subjects Protection Program. This review process helps protect the rights and welfare of clinical research participants by ensuring that ethical standards are met and that the research complies with regulatory requirements.
Clinical Trials at WFBMC are sponsored by pharmaceutical companies, the National Institutes of Health (NIH), the National Cancer Institute (NCI), and many other organizations.
Types of Clinical Research
Clinical trials are research studies conducted in people to determine whether treatments are safe and effective. Clinical trials are the best way for researchers to find new ways to detect, slow, treat and hopefully someday prevent diseases.
What's the difference between a clinical trial and a clinical study?
Clinical trials are sometimes referred to as clinical studies. While clinical trials technically refer only to those clinical studies involving drugs and other therapies aimed at slowing or stopping a disease, the terms are often used interchangeably.
There are five common types of clinical trials/studies:
- Interventional trials to test potential theraputic interventions that may improve care of patients in the future
- Diagnostic studies to find new tests or procedures for diagnosing a disease or condition
- Prevention trials to investigate ways to prevent the onset of diseases
- Screening studies to test methods to identify diseases or conditions at the earliest stages
- Quality of life studies to look at different ways to improve quality of life for individuals who have a chronic illness
Perhaps the best known clinical studies are those that investigate possible improvements in therapies. Before a new drug or treatment can be approved by the FDA, it has to go through three phases of clinical trials. Most of the time, a clinical trial is designed to compare an investigational therapy with the best-known existing therapy for the disease being studied. When there is no proven treatment to use as a comparison, researchers sometimes compare an investigational drugs with a placebo, which is a sugar pill or other inactive substance that has no theraputic value but is made to look like the new drug in development.
Many clinical studies focus on finding better ways to accurately diagnose diseases. These studies will hopefully lead to improved and easier methods enabling physicians to diagnose persons at risk for various diseases.
Researchers look for ways to stop disease from developing, often times in groups of people identified as being at higher risk. This type of study looks at whether a certain medication, vitamin or lifestyle change (for example, healthy eating or exercise) might prevent disease.
Researchers also look for ways to detect disease as early as possible. Being able to diagnosis disease early on provides an opportunity for care planning and to receive as much benefit as possible from current treatments.
Quality of Life Studies
Researchers try to better understand and address the needs of people with disease and their caregivers. The goal of such studies is to figure out what types of support, education or training solve some of the challenges faced by people and their caregivers.