What is clinical research?
Better research helps researchers and practitioners
understand a disease, condition, or disability
as well as examine and develop ways to prevent, diagnose, treat and improve quality of life.
It is the foundation of advances
in healthcare processes, treatments, and technologies.
Clinical research helps determine whether treatments are safe and effective. It is used to help improve quality of life for people who are experiencing temporary as well as ongoing (chronic) illness.
Types of Clinical research include:
- Natural history studies to gather information about health and disease
- Screening trials to identify how to detect a disease or condition
- Diagnostic trials to determine best tests or procedures for diagnoses
- Treatment trials that include medication(s), surgery, procedures, and other therapies
- Prevention trials, including medication, vaccines, and lifestyle changes to help prevent disease from occurring and recurring
- Quality of life (or supportive care) trials to identify ways to improve quality of life for people with chronic illness
Clinical research can give participants hope
for overcoming a disease or condition.
About Clinical Research
All clinical research in the United States is conducted with the review and approval of an accredited, independent review board (IRB) comprised of physicians, and statisticians. The IRB reviews each clinical trial before and during research to ensure the trial is ethical, participants’ rights are protected, and that risks are minimal.
Clinical research involves a plan known as a protocol that:
- Identifies the purpose of the trial
- Outlines who can participate (eligibility)
- Defines how long the study will last (study duration) and its phases
- Describes the treatments, including frequency and dosages of medication
- Gives details about tests and procedures
- Identifies the researchers, including a principal investigator and coinvestigator(s)
- Specifies information the researchers will gather
- Suggests whether the data will be published
Informed consent is an important part of the clinical research process. It helps people decide whether to participate in a clinical trial. During informed consent, researchers explain details of the study, including its purpose, length, treatments involved, required tests and procedures, and benefits and risks. Participants also are given contact information so that participants know whom to call to get answers to their questions. Once a trial is underway, participants continue receiving information about the trial as part of informed consent.
All participants must sign a document of informed consent
to engage in Clinical research.
Informed consent is not a contract. All participants for clinical research are considered volunteers who are free deny treatments, test, or procedures as well as withdraw from the study. In some cases, however, denying treatments, tests, or procedures can mean being unable to complete (or becoming ineligible for) the trial.
Clinical researchers learn about disease processes
when they compare healthy volunteers
with patient groups in a clinical trial.
Before enrolling in Clinical research,
potential participants must qualify for it.
If you are considering enrolling in Clinical research, you should consider:
- Risks, including:
- Unpleasant side effects it might cause
- Potential complications that require additional medical attention
- Visits to the study site and time it takes from your other activities
- The need for additional treatments, test, and hospital stays
- Possible costs to you for traveling to the study site
- Benefits, including:
- Having an active role in your health care
- Access to new treatments before they are available to others
- Receiving medical care and attention from doctors and other health care practitioners
- Contributing to the health and well-being of others
Once a new treatment, device, or intervention
is proven safe and effective in Clinical research,
it can become a standard of medical practice.