Frequently Asked Questions about Drug Studies
- What are drug studies?
- What do Phase I, Phase II, Phase III and Phase IV Clinical Trial mean?
- What is a "placebo" and why are they used?
- What does "double blind" mean?
- What does "randomization" mean?
- What is Informed Consent?
- Is there a charge to participte in clinical trials?
- Who is eligible to participate?
What are drug studies?
Drug studies, also referred to as clinical trials, are the means by which new drugs, or new uses for drugs, are tested in human beings for effectiveness and safety. New devices and even some medical procedures are tested in the same way. Usually, the new method of treatment is compared to the current method of treatment. If there is no suitable current method of treatment, the new method is compared to a placebo, a non-active look-a-like which is expected to have no effect.
What do Phase I, Phase II, Phase III and Phase IV Clinical Trial mean?
Following laboratory and animal studies, Phase I clinical trials are performed on healthy volunteers, and are concerned with drug safety only. They are used to determine an acceptable single drug dosage. Phase II clinical trials are used to determine effectiveness and safety in patients with the disease under study. The few drugs with genuine potential are selected from these trials and enter Phase III trials, which are large studies involving a substantial number of patients. This is the most extensive and rigorous trial and drugs, devices, or procedures which have positive results will enter the application process for acceptance by the Food and Drug Administration (FDA). Phase IV trials are usually performed for marketing purposes after the drug has been approved by the FDA.
What is "placebo" and why are they used?
A placebo is an inert substance that is expected to have no effect on the patient. It looks like the active drug. In order to tell if a drug, medical device, or procedure has any effect on a group of patients, it must be compared with a similar group of patients taking the standard treatment, or a placebo.
What does "double blind" mean?
Double-blind means that neither the patient, nor the researcher, knows which treatment the patient is receiving, either active drug or placebo. This prevents bias in the results which could occur if the patient or researcher expected a certain result.
What does "randomization" mean?
This is the mechanism by which individuals are assigned to either the active treatment or placebo (or standard treatment) once they have volunteered to participate and are determined to be eligible. It is like the flip of a coin. Your chance of being put in any group is about the same.
What is Informed Consent?
This document contains detailed information about the research in which the subject is being asked to participate. It explains the purpose of the research a nd describes the procedures involved as well as the number of visits expected. The Informed Consent also presents the potential risks as well as the possible benefits, and discusses confidentiality and the voluntary nature of participation. In research studies that involve a person with cognitive impairment, both the patient and the patient's caregiver (health care surrogate) must sign.
Is there a charge to participate in clinical trials?
Once it is determined that a patient appears to meet the criteria for a specific study and the Informed Consent is signed, there are no costs associated with the research study. Whether or not a patient appears to meet the requirements of the study can often be ascertained through a review of previous medical records. If the patient has not had an evaluation of the memory disorder, or the records are incomplete, an evaluation can be obtained by the clinical services team at Suncoast Gerontology Center.
Who is eligible to participate?
Eligibility criteria differs with each clinical trial however, there are some requirements that generally apply. In studies for the treatment of Alzheimer's disease, the patient must have documentation of probable Alzheimer's disease, usually accompanied by a magnetic resonance imaging (MRI) or a computerized tomography (CT) scan to rule out other causes. In most cases, the patient must be mildly to moderately impaired, otherwise in generally good health, and have a family caregiver who can accompany the patient to testing visits at the research site.