Understanding Clinical Trials

A Guide for Participants

Clinical trials are research studies that evaluate new medical approaches and increase scientific understanding of a wide variety of diseases.

At Duke, we believe that this research is key to improving health care throughout the world. Our goal is to quickly translate research findings into clinical care that benefits all patients.

Why Clinical Trials Are Important

Advances in medicine and science come from new ideas and approaches developed through research. New medical treatments must prove to be safe and effective in scientific studies with a certain number of patients before they can be made widely available.

Through clinical trials, researchers at Duke learn which approaches are more effective than others. A number of treatments that are now standard were first shown to be effective in clinical trials.

Scientists may conduct clinical trials to accomplish a variety of research goals. The different types of clinical trials are:

  • Treatment trials, which test new drugs, medical devices, medical procedures, or combinations of treatments
  • Prevention trials, which look for better ways to prevent diseases through medicines, vaccines, vitamins, minerals, or lifestyle changes
  • Screening trials, which look for new ways to test for the presence of a disease or health condition
  • Quality of life trials, which explore ways to improve comfort and quality of life for chronically ill individuals

Benefits to You

Involvement in a clinical trial is strictly voluntary, but people who participate can experience benefits.

Here are some benefits you could receive as a clinical trial subject:

  • Access to promising drugs, medical devices, or treatment approaches before the general public
  • Free or subsidized health care for the duration of the trial
  • A more active role in your own health care
  • Expert medical care at a leading health care facility
  • Close monitoring of your health care and side effects

And if you decide to participate in a clinical trial at Duke, you’ll play in important role in advancing scientific knowledge and helping future patients.

Duke Is a Clinical Research Site

The School of Medicine Clinical Research Units (CRUs) are the organizational and functional structures that provide support for clinical research in which a Duke Health department, center/institute, CSU or school serves as the investigative sites for the research, or a Duke facility or staff member is responsible for a research activity that involves intervention or interaction with Duke patients, use of biological specimens from Duke patients or access to confidential, private information from Duke patients. The CRU is the operating business unit responsible for oversight including integrity, financial accountability, regulatory compliance, quality and academic productivity of clinical research studies. The Duke Office of Clinical Research (DOCR) supports the CRUs by developing the “navigation, tools, and training” for the conduct of clinical research in which Duke serves as an investigative site.

In 2013, there were more than 4000 active studies in the Clinical Research Units at Duke with 30% funded by industry and 30% funded by the federal government. The remaining research portfolio is supported by other non-profit foundations and internal funding.

Research at Duke

Duke Clinical Research Institute (DCRI) is the world’s largest academic clinical research organization. DCRI’s mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research.

DCRI enrolls patients in close to 1,800 trials at any given time. Though best known for its pioneering cardiovascular trials, the DCRI conducts studies in more than 20 therapeutic areas.

Our faculty are all practicing physicians in these specialties, applying cutting-edge research in their own patient care. Their informed input on study design and interpretation creates more efficient, practical, and hard-hitting research.