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Research glossary ADVERSE REACTION(Adverse Event.) An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time (See Side Effects).Top ADVOCACY AND SUPPORT GROUPSOrganizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools.Top ARMAny of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more (See Randomized Trial).Top BASELINE1. Information gathered at the beginning of a study from which variations found in the study are measured. 2. A known value or quantity with which an unknown is compared when measured or assessed. 3. The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested.Top BIASWhen a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization (See Blind and Randomisation).Top BLINDA randomised study is "Blind" if the participant is not told which arm of the trial they are on. A study is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. (See Single Blind Study and Double Blind Study).Top CLINICALPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science.Top CLINICAL TRIALA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed.Top COHORTIn epidemiology, a group of individuals with some characteristics in common.Top CONFIDENTIALITYRefers to maintaining the confidentiality of studies participants including their personal identity and all personal medical information. The studies participants' consent to the use of records for data verification purposes should be obtained prior to the study and assurance must be given that confidentiality will be maintained.Top CONTRAINDICATIONA specific circumstance when the use of certain treatments could be harmful.Top CONTROL GROUPThe standard by which experimental observations are evaluated. In many studies, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.Top CONTROLLED TRIALSControl is a standard against which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimental drug, while another group (i.e., the control group) is given either a standard treatment for the disease or a placebo.Top CRITERIAInclusion and exclusion criteria are conditions that must be met for eligibility into a study.Top DIAGNOSTIC TRIALSRefers to trials that are are conducted to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usually include people who have signs or symptoms of the disease or condition being studied.Top DOSE-RANGING STUDYA clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful.Top DOSE RESPONSEThe amount of response that is achieved from an amount of dose. Some things have a dose response relationship (i.e. the more you take the greater the response), while others do not (doesn't matter how much the dose is, the response is the same)Top DOUBLE-BLIND STUDYA study design in which neither the participating individuals nor the study staff knows which participants are in the experimental group and which are in the control group. Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study. See Blind, Single-Blind Study, and Placebo.Top DRUG-DRUG INTERACTIONA modification of the effect of a drug when administered with another drug. The effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug.Top EFFICACY(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed.Top EMPIRICALBased on experimental data, not on a theory.Top ENDPOINTOverall outcome that the protocol is designed to evaluate.Top ENROLLINGThe act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process.Top EPIDEMIOLOGYThe branch of medical science that deals with the study of incidence and distribution and control of a condition in a population.Top ETHICS (COMMITTEE)An ethical review board is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects.Top EXPERIMENTALA drug, treatment or procedure that is being examined.Top HYPOTHESISA supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation.Top INCLUSION/EXCLUSION CRITERIAThe medical or social standards determining whether a person may or may not be allowed to enter a study. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.Top INFORMED CONSENTThe process of learning the key facts about a study before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the study explain the details of the study.Top INTERVENTIONSomething which may change a disease or condition. Types of interventions typically include Drug, Gene Transfer, Vaccine, Behavior, Device, or Procedure.Top INVESTIGATORA medical researcher in charge of carrying out a studies protocol.Top IN VITROIn an artificial environment outside the living organism (i.e. test tube)Top IN VIVOIn the living organism (i.e. in the body)Top OBSERVATIONALA type of study where there is no intervention of experimental group. Findings are reported as a natural occurrence.Top MASKEDThe knowledge of intervention assignment. See BlindTop PEER REVIEWReview of research by experts chosen by the study sponsor. These experts review the research for scientific merit, participant safety, and ethical considerations.Top PHARMACOKINETICSThe processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.Top PHASE I TRIALSInitial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.Top PHASE II TRIALSControlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.Top PHASE III TRIALSExpanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.Top PHASE IV TRIALSPost-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.Top PLACEBOA placebo is an inactive pill, liquid, or powder that has no treatment value. In controlled trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness.Top PLACEBO EFFECTA physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance.Top PRECLINICALRefers to the testing of experimental drugs in the test tube or in animals - the testing that occurs before trials in humans may be carried out.Top PREVENTION TRIALS/STUDIESRefers to research to find better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.Top PROTOCOLA study plan on which all research studies are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the study; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a study, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.Top RANDOMISATIONA method based on chance by which study participants are assigned to an experimental or control group Randomisation minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. This removes potential bias from the study.Top RANDOMISED CONTROL TRIALA study in which participants are randomly (i.e., by chance) assigned to one of two or more treatment arms of a study. Occasionally placebos are utilized.Top RECRUITINGThe period during which a study is attempting to identify and enroll participants. Recruitment activites can include advertising and other ways of solicting interest from possible particpants.Top RESEARCH STUDY:A scholarly or scientific investigation and in the pursuit of complete understanding of a topicTop RISK-BENEFIT RATIOThe risk to individual participants versus the potential benefits. The risk/benefit ratio may differ depending on the condition being treated.Top SCREENING TRIALSRefers to trials which test the best way to detect certain diseases or health conditions.Top SIDE EFFECTSAny undesired actions or effects of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects (See Adverse Reaction).Top SINGLE-BLIND STUDYA study in which one party, either the investigator or participant, is unaware of what treatment group the participant is in; also called single-masked study. (See Blind and Double-Blind Study).Top SINGLE-MASKED STUDYSee Single-Blind Study.Top STANDARD TREATMENTA treatment currently in wide use, considered to be effective in the treatment of a specific disease or condition.Top STATISTICAL SIGNIFICANCEThe probability that an event or difference occurred by chance alone. In scientific research, the level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed.Top STUDY TYPEThe primary investigative techniques used to explore outcomes. Types include experimental and observationalTop TOXICITYAn adverse effect produced by a drug that is detrimental to the participant's health. The level of toxicity associated with a drug will vary depending on the condition which the drug is used to treat.Top TREATMENT TRIALSRefers to trials which test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. |