APPROVED DRUGS: This refers to substances that in the United States have gone through a several step process that is overseen by the Food and Drug Administration (FDA). These steps include pre-clinical laboratory research, animal studies, and clinical trials. Once the research is completed the FDA reviews the manufacturer submitted application and approves or denies it.
BIAS: This is when people impart their impartial judgment on a study. For example if someone takes an experimental treatment they may claim to feel better simply because it is a different treatment and not necessarily a better treatment.
BLIND: This refers to a randomized trial when the patient is not told which group (or arm) of the trial he is on. This help to ensure more valid testing as the patient does not know whether they are receivng the experimental treatment or not.
CLINICAL INVESTIGATOR: This is the medical researcher that is responsible for conducting a clinical trial's protocol.
CLINICAL TRIAL: This is a research study that seeks to research new vaccines or treatments. Clinical trials are medical research studies that are conducted to figure out whether these new drugs and/or treatments are both safe and effective for general human use. Clinical trials are in grouped into four different phases. See Phase I, Phase II, Phase III and Phase IV below.
COMMUNITY-BASED CLINICAL TRIAL (CBCT): These are clinical trials that conducted through your primary-care doctors rather than formal academic research facilities. This provides the benefit of having your personal doctor who is more familiar with you and has better access to a group of patients.
COMPASSIONATE USE: This is a less common method of providing the experimental treatments before the final FDA approval for general use in humans. This is generally only done with very ill patients who have no other alternative options. For compassionate use to apply, special approval must be recevied from the FDA.
CONTROL GROUP: This is the group of patients that receive the currently exisitng care and are not provided witht he experiemental treatment. This provides data that can be used as the standard by which experimental observations are evaluated against.
DATA SAFETY AND MONITORING BOARD (DSMB): This is an independent committee that consists of representatives from the community and medical experts. Their role is to review the data during a clinical trial to ensure the safety of all participants and that unneccasary risks are not taken. If they find a potential danger with the study the DSMB may recommend that a trial be stopped.
DIAGNOSTIC TRIALS: These are trials that are performed not to find better treatments but to find better ways of researching and testing. So future clinical trials may gather more accurate information through smart testing procedures.
ELIGIBILITY CRITERIA: These are the factors that will determine whether a person may participate or not in clinical trial. Factors can include age, weight, severity of condition and other factors.
FOOD AND DRUG ADMINISTRATION (FDA): This is part of U.S. Department of Health and Human Services. It is responsible for ensuring the effectiveness and safety of all drugs and medical devices that are used in the general public. Another responsibility is to ensure the safety of the national blood banking industry.
INFORMED CONSENT: This is when a patient becomes educated about the key facts pertaining to a clinical trial including the dangers and risks it may pose before making a decision on whether or not to participate. This knowledge is a updated and provided to the patient throughout the trial.
INSTITUTIONAL REVIEW BOARD (IRB): This board consists of doctors, medical researchers and patient advocates. Their responsibility is to ensures that a trial is being conducted ethically and that the patients rights are being protected. Before a clinical trial begins in the United States it must be approved by an IRB.
NEW DRUG APPLICATION (NDA): This is the formal application that must be submitted by a drug manufacturer to request approval from the FDA for a new drug/treatment based on positve clinical trial resech having been completed.
ORPHAN DRUGS: This is a special status that the FDA can apply to a medications that is used to treat rare diseases or rare conditions. This special status helps provide a financial incentive to the pharmaceutical industry to develop medications that would not exist since these rare diseases and conditions also have a low demand.
PHASE I CLINICAL TRIALS: This is the first part of the research. It is designed to explore the side effects associated with dosage and to start collecting initial evidence of effectiveness.
PHASE II CLINICAL TRIALS: This is the secondary part of research intended to determine the effectiveness of a drug and its interaction in patients to determine the common short-term side effects and risks.
PHASE III CLINICAL TRIALS: This provides a larger amount of participants based on the phase I and phase II data. Its purpose is to gather a wider amount of research data in order to determine the benefit-risk relationship of a drug.
PHASE IV CLINICAL TRIALS: This is a post-marketing study to determine additional information including more specific drug's risks, benefits, and determine the optimal use.
PLACEBO: A placebo is an inactive pill, liquid, or powder that has no treatment value. A placebo may be provided to the control group so that they remain unware that they are not receivng the experimental treatment, thus ensuring more accurate data.
RISK-BENEFIT RATIO: This is the amount of risk to individual patients compared against the potential benefits. The risk/benefit ratio will be different depending the condition being treated and the health status of the patient.