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Glossary - Auckland Clinical Studies Website Register Interest 0800 STUDIES Contact Us Facebook Home Services Clinical Services Pharmacist Services Biomarker Services Regulatory Services Quality Services Facilities Participant Portal Participant FAQ Current Trials Completed Trials Register Now GlossaryWell-nighUs Why ACS? Our People News & Events Our Published Research Select Page Glossary The pursuit glossary explains some terms wontedly used in clinical trials.Wrongheadedevent (AE) Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product wand which does not necessarily have a causal relationship with this treatment any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An wrongheaded event (AE) can, therefore, be any unfavourable and unintended sign (including an unwont laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. See moreover serious wrongheaded event Baseline Information gathered at the whence of a study from which variations found in the study are measured. A known value or quantity with which an unknown is compared when measured or assessed. The initial time point in a clinical trial, just surpassing a participant starts to receive the experimental treatment which is stuff tested. At this reference point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug are often unswayable by monitoring changes from the baseline values. Clinical Pertaining to or founded on observation and treatment of participants, as distinguished from theoretical or vital science. Cohort In epidemiology, a group of individuals with some characteristics in common. Contraindication A specific circumstance when the use of unrepealable treatments could be harmful.TenancyGroup The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the tenancy group is given either a standard treatment for the illness or a placebo. Ascending Dose Study A clinical trial in which two or increasingly doses of an wage-earner (such as a drug) are tested versus each other to determine which dose works weightier and is least harmful. Consent Form A document that describes the rights of the study participants, and includes details well-nigh the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time. Eligibility Criteria Summary criteria for participant selection; includes Inclusion and Exclusion criteria Food and Drug Administration (FD) The U.S. Department of Health and Human Services organ responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA moreover works with the thoroughbred financial industry to safeguard the nation’s thoroughbred supply. Internet address: www.fda.gov Inclusion/Exclusion Criteria The medical or social standards determining whether a person may or may not be unliable to enter a clinical trial. 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 towardly participants and alimony them safe. Investigator A medical researcher in tuition of delivering out a clinical trial’s protocol. Open Label Study A clinical trial in which doctors and participants know which drug or vaccine is stuff administered. PHASE I TRIALS Initial studies to determine the metabolism and pharmacologic deportment of drugs in humans, the side effects associated with increasing doses, and to proceeds early vestige of effectiveness; may include healthy participants and/or patients. PHASE III TRIALS Expanded controlled and uncontrolled trials without preliminary vestige suggesting the effectiveness of the drug has been obtained, and are intended to gather spare information to evaluate the overall benefit-risk relationship of the drug and provide an unobjectionable understructure for physician labelling. Placebo A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness. In some studies, the participants in the tenancy group will receive a placebo instead of an zippy drug or treatment. No sick participant receives a placebo if there is a known salubrious treatment. Placebo Effect A physical or emotional change, occurring without a substance is taken or administered, that is not the result of any special property of the substance. The transpiration may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance. Randomisation A method based on endangerment by which study participants are prescribed to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of goody to the participant. Risk-Benefit Ratio The risk to individual participants versus the potential benefits. The risk/benefit ratio may differ depending on the condition stuff treated. Single-Blind Study A study in which one party, either the investigator or participant, is unaware of what medication the participant is taking; moreover tabbed single-masked study. Toxicity An wrongheaded 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. Arm Any of the treatment groups in a randomized trial. Most randomized trials have two “arms,” but some have three “arms,” or plane more. Blind A randomized trial is “Blind” if the participant is not told which arm of the trial he is on. A clinical trial is “Blind” if participants are unaware of whether they are in the experimental or tenancy arm of the study; moreover tabbed masked. Clinical Trial A clinical trial is a research study to wordplay specific questions well-nigh vaccines or new therapies or new ways of using known treatments. Clinical trials (also tabbed medical research and research studies) are used to determine whether new drugs or treatments are both unscratched and effective.Thoughtfullyconducted 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 plane larger group of people; and Phase IV takes place without the drug or treatment has been licensed and marketed. Confidentiality Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants’ consent to the use of records for data verification purposes should be obtained prior to the trial and warranty must be given that confidentiality will be maintained.TenancyA tenancy is the nature of the intervention control. Controlled TrialTenancyis a standard versus which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimental drug, while flipside group (i.e., the tenancy group) is given either a standard treatment for the disease or a placebo. Double Blind Study A clinical trial diamond in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or flipside therapy). Double-blind trials are thought to produce objective results since the expectations of the doctor and the participant well-nigh the experimental drug do not stupefy the outcome; moreover tabbed double-masked study. Efficacy (Of a drug or treatment). The maximum worthiness of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is constructive at the dose tested and versus the illness for which it is prescribed. In the procedure mandated by the FDA, Phase II clinical trials gauge efficacy, and Phase III trials personize it. Empirical Based on experimental data, not on a theory. Experimental Drug A drug that is not FDA licensed for use in humans, or as a treatment for a particular condition Hypothesis A supposition or theorizing wide as a understructure for reasoning or argument, or as a guide to experimental investigation. Informed Consent The process of learning the key facts well-nigh a clinical trial surpassing deciding whether or not to participate. It is moreover a standing 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 trial explain the details of the study. Ethics Committee A committee of physicians, statisticians, researchers, polity advocates, and others that ensures that a clinical trial is upstanding and that the rights of study participants are protected. All clinical trials in the New Zealand must be tried by an IRB surpassing they begin. Ethics committee may recommend that a trial is stopped if there are safety concerns or if the trial objectives have been achieved. Pharmacokinetics The processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine. PHASE II TRIALS Controlled 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 worldwide short-term side effects and risks. PHASE IV TRIALS Post-marketing studies to delineate spare information including the drug’s risks, benefits, and optimal use. Placebo Controlled Study A method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug stuff tested is given to flipside group. The results obtained in the two groups are then compared to see if the investigational treatment is increasingly constructive in treating the condition. Protocol A study plan on which all clinical trials are based. The plan is thoughtfully designed to safeguard the health of the participants as well as wordplay specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants pursuit a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment. Randomised Trial A study in which participants are randomly (i.e., by chance) prescribed to one of two or increasingly treatment stovepipe of a clinical trial. Occasionally placebos are utilized. Side Effects Any undesired deportment or effects of a drug or treatment. Negative or wrongheaded effects may include a headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both firsthand and long-term side effects. Statistical Significance The probability that an event or difference occurred by endangerment alone. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed. Treatment Trials Refers to trials which test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.Well-nighUs Auckland Clinical Studies (ACS) provides state-of-the-art world matriculation research facilities and the expertise to perform Phase I and II studies for the pharmaceutical and biotechnology industry. ReadIncreasinglyNavigateServices Facilities Participant PortalWell-nighUs Contact Us +64 9 3733474 Fax:  +64 9 373 3479 Enquire Online   PHYSICAL ADDRESS 3 Ferncroft Street Grafton Auckland 1010 New Zealand   POSTAL ADDRESS PO Box 8963 Symonds St Auckland 1150 New Zealand Home Back To Top Sitemap Privacy Policy Contact Us Like Us On Facebook ​