What is Clinical Research?
Also known as clinical trials, clinical research involves patients who might benefit from new treatments that are not yet available. Research physicians use clinical research to test a medication, device, treatment approach, or medication dose. All research includes a panel of experts, also known as physician investigators, who decide how best to use the new treatment. The investigators also identify the types of patients who are likely to benefit most from the treatment. To be eligible for a clinical trial, the patients must fit certain criteria.
During a clinical trial, the researchers track and make note of all the changes (data) subjects experience as a result of the treatment they are given. The data are then used to make decisions about whether to use the medication, device, or treatment for a wide range of patients.
People who participate in medical research and clinical trials are volunteers.
In general, clinical research helps determine whether:
- A new medication, device, treatment, or dose is safe and effective for a specific type of patient
- An already marketed medication or device can be used for a different disease or condition than the one for which it was originally intended
- A new medication, device, or treatment is more effective than previous treatments for a disease or condition
Medical clinical trials also sometimes compare more than one medication, device, or treatment to determine which is the most effective.
What to Expect
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. Clinical research can give participants hope for overcoming a disease or condition.
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
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.
Enrolling in Clinical Research
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.