Norton Research Institute is dedicated to conducting high-quality research that brings new treatments to those who need it and keeps our community’s medical providers at the leading edge of advancements and discoveries.

Clinical Trials and Research Studies

One of the most common ways for patients to participate in research is through a clinical trial. You and your provider will have a conversation to help you decide whether a clinical trial is right for you. It is important to know that experimental treatment is not the path for everyone.

Researchers conduct thousands of clinical trials every year in the U.S. These trials test medications, treatments and therapies for a wide variety of medical conditions, such as cancer, neurologic disorders and muscular diseases.

Clinical trials are formal research studies that look at how well new medical approaches work in people. Each study answers specific questions and tries to find new and better ways to prevent, screen for, diagnose and treat many diseases. Clinical trials also may compare a new treatment with older approaches to determine whether the newer therapy is more effective and safer. Not all trials deal with treatments. Some may focus on making better diagnoses or ways to prevent health issues.

Clinical Trials Frequently Asked Questions

Phases of Clinical Trials

As part of clinical research, drug trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

• Phase 1 trials: Also known as early phase clinical trials, researchers conduct the first human trials of a new drug or treatment in a small group — 20 to 80 volunteers — to evaluate its safety, determine a safe dosage range and identify side effects.
• Phase 2 trials: The study drug or treatment is given to a larger group of people (100 to 300) to test its effectiveness and to further evaluate its safety.
• Phase 3 trials: The study drug or treatment is given to large groups of people (1,000 to 3,000) to confirm its effectiveness, monitor side effects, compare it with commonly used treatments and collect information that will allow the drug or treatment to be used safely.
• Phase 4 trials: Conducted after a treatment has been approved for broad use, these studies collect and report additional information, including the drug’s risks, benefits and optimal use.

Areas of Research at Norton Healthcare

At any time, Norton Research Institute is participating in more than 1,100 trials and studies involving more than 30 specialties. Our active research portfolio includes:

• Translational research
• Phase 1, Phase 2 and Phase 3 investigational drug clinical trials
• Device studies
• Health outcome studies
• Biorepository and bench lab research
• Data collection

Researchers can get information about starting a trial, learn about applications and requirements, get access to policies and forms, and get answers to frequently asked questions.

Contact Us

Norton Research Institute
224 E. Broadway, Seventh Floor (M-05)
Louisville, KY 40202
Phone: (502) 629-3500
Fax: (502) 629-3480

If you are participating in a study at a Norton Healthcare facility and have concerns about that research project, call Norton Research Institute at (502) 629-3500 or email ro@nortonhealthcare.org for assistance.

Norton Research Institute is responsible for the application of and adherence to the medical research policies of Norton Healthcare. Norton Research Institute is not a substitute for the Institutional Review Board but serves as Norton Healthcare’s advocate to ensure that all research is conducted according to the policies of Norton Healthcare.

Norton Healthcare:

• Protects the interest and well-being of participants in research at Norton Healthcare
• Upholds regulations as set forth in the Code of Federal Regulations concerning research in human participants
• Upholds the ethical guidelines set forth in the Nuremberg Code, International Conference on Harmonization and the Belmont Report