Clinical Trials
Many of our physicians take part in national studies of new treatments. These clinical trials allow doctors to find drugs and procedures to treat cancer, diabetes and other illnesses so they can recover from serious diseases. If you are accepted for a clinical trial, you may undergo new treatments before they are available to general public.
ECU Physicians’ patients may participate in clinical trials. These clinical trials hold promise of helping serious illnesses, such as cancer, after other treatments have failed. Your doctor can help you decide whether to participate.
You may or may not experience benefits from the clinical trial and even your doctor won’t know if you are receiving the new treatment since the studies are blinded and randomized. These trials may involve several departments, such as pharmacy, radiology or others.
While new drugs, devices, procedures and treatments may help some patients, we must follow all federal, state and institutional regulations, policies and procedures to protect the privacy, safety and interests of patients and university.
NIH Definition of a Clinical Trial
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Link to information: NIH’s Definition of a Clinical Trial | grants.nih.gov
Your study is considered to meet the NIH definition of a clinical trial even if:
- Your study uses healthy participants, or does not include a comparison group (e.g., placebo or control)
- Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
- Your study utilizes a behavioral intervention
- Your study uses an intervention for the purposes of understanding fundamental aspects of a phenomenon (See more information about Basic Experimental Studies with Humans).
Your study is NOT considered to meet the NIH definition of a clinical trial if:
- Your study is intended solely to refine measures.
- Your study involves secondary research with biological specimens or health information.
For more information, call our Clinical Trials Office at 252-744-3212. You may also contact Jackie Moore, Senior Clinical Trials Contract Negotiator, at moorejac@ecu.edu.