What Is Clinical Research?
Clinical research helps create new health treatments like new medicines or new ways to use medicines, new ways to do surgeries, new medical devices, new health classes and educational materials, new ways to diagnose illnesses, and other new ways to stay healthy. Clinical research also finds new diseases and ways to prevent diseases. Changes to medical care often come from people taking part in clinical studies.
All clinical research is done with participants who are volunteers, either patients or other community members, who have an interest in helping to improve healthcare.
Types of Clinical Research
There are many different types of research studies. Some examples of common research done at Duke are:
- Epidemiology Studies: Looks at where diseases happen and who is affected by them.
- Behavioral Studies: Finds out how what we do can improve or worsen health and disease.
- Prevention Studies: Finds new ways to keep people from getting diseases or to stop diseases from coming back. These studies look at things like medicines, vitamins, shots, minerals, or ways to live healthier.
- Genetic Studies: Looks at how a person’s genetics affect diseases.
- Observational Studies: Collects information from volunteers over time to understand how illnesses develop and what affects a person’s health.
Community-Based Research is research that includes people from all across the communities contribute to the planning and carrying out of the study. These studies can be any type of study.
Another type of research is called a clinical trial. These are research studies to find new ways to prevent, find, or treat diseases. They may test new drugs, surgeries, devices, and lifestyle changes to determine their safety and effectiveness. Clinical trials have different phases, and each phase has its own goal.
Clinical Trial Phases
- Phase I: Test a new treatment's safety and side effects.
- Phase II: Expand testing to see if the treatment is effective and safe.
- Phase III: Make large-scale comparisons with other treatments.
- Phase IV: After a treatment is approved by the FDA, watch for long-term effects across those who use the treatment.
Randomized and Blinded Clinical Trials
Participants are randomly assigned to different treatment groups. In blinded trials, the participants, doctors, and researchers don’t know who receives which kind of treatment. This makes sure that the results aren’t biased by what they think will work the best.
All research studies must have their plans reviewed and approved of by an Institutional Review Board (IRB) that includes doctors, researchers, and community members, before they can get started. The IRB ensures the safety and fairness of studies. It reviews and monitors the study protocol, consent forms, and progress to protect participants.