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Glossary

Adverse Reactions: An unwanted effect caused by the administration of a treatment of drug. Onset may be sudden or develop over time.

Advocacy and Support Groups: Organizations and groups that actively support participants and their families with valuable resources including self-empowerment and survival tools.

Approved Drugs/Devices: In the US, the FDA must approve a device or substance (as a drug)before it can be marketed. The approved process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug/Treatment application by the manufacturer of the drug/implant, FDA reveiw of the application, and FDA approval/rejection of application.

Arm: Any of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more.

Baseline: 1) 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. At this reference point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values.

Bias: When 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.

Clinical: Pertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science.

Clinical Investigator: A medical researcher in charge of carrying out a clinical trial's protocol.

Clinical Trial: a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted trials are the fastest and safest way to find treatments that work in people.

Cohort: In epidemiology, a group of individuals with characteristics in common.

Community-Based Trial: A clinical trial conducted primarily through primary-care physicians rather than academic research facilities.

Compassionate Use: A method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who have no other treatment options.

Complementary and Alternative Therapy: Broad range of healing philosophies, approaches, and therapies that Western medicine does not commonly use to promote well-being or treat health conditions. Examples include acupuncture, herbs, etc.

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 assurance must be given that confidentiality will be maintained.

Contraindication: A specific circumstance when the use of certain treatments could be harmful.

Control Group: The standard by which experimental observations are evaluated. Many clinical trials, one group of patients will be given experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

Controlled Trials: Control 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 is given either a standard treatment for the disease or a placebo.

Data Safety and Monitoring: An independent committee composed of community representatives and research experts that review data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved.

Diagnostic Trials: Refers to trials that 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.

Dose-ranging study: A clinical trial in which two or more doses of an agent are tested against each other to determine which dose works best and is lease harmful.

Double-Blind Study: A clinical trial design 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 another therapy). Double blind trials are thought to produce objective results, since the expectations of the clinician and participant about the experimental treatment do not affect the outcome; also called double-masked study.

Drug-Drug Interaction: A modification of the effect of a drug when administered with another drug. The effect may be an increase or decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug.

Efficacy: The maximum ability of a drug or treatment to produce a result regardless of dosage.

Empirical: Based on experimental data, not on theory.

Endpoint: Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death.

Epidemiology: The branch of medical science that deals with the study of incidence and distribution and control of a disease in a population.

Experimental Drug: A drug that is not FDA licensed for use in humans or as a treatment for a particular condition.

Food and Drug Administration: The US Dept of Health and Human Services agency 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 also works with the blood banking industry to safeguard the nation's blood supply.

Informed Consent: the process of learning the key facts about a clinical trial 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 trial explain the details of the study.

Institutional Review Board (IRB): A committee of physicians, statisticians, researchers, community advoccates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the US must be approved by an IRB before they begin. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants.

Intent to Treat: Analysis of clinical trial results that includes all data from participants in the groups to which they are randomized even if they never received treatment.

Open Label Trial: A clinical trial in which doctors and participants know which drug or vaccine is being administered.

Peer Review: Review of a clinical trial by experts chosen by the study sponsor. These experts review the trials for scientific merit, participant safety, and ethical considerations.

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 control group will receive a placebo instead of an active drug or treatment. No sick participant receives a placebo if there is a known beneficial treatment.

Preclinical: Refers 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.

Prevention Trials: Refers to trials 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, vitamins, vaccines, minerals, or lifestyle changes.

Protocol: A study plan on which all clinical trials 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 trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, 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.

Randomization: A method based on chance by which study participants are assigned 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 no know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit 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 being treated.

Single-Blind Study: A study in which one party, either the investigator or participant is unaware of what medication the participant is taking; also called single-masked study.

Standard Treatment: A treatment currently in wide use and approved by the FDA, considered to be effective in the treatment of a specific disease or condition.

Treatment IND: IND stands for Investigational New Drug application, which is part of the process to get approval from the FDA for marketing a new prescription drug in the US. It makes promising new drugs available to desperately ill participants as early in the drug development process as possible. Treatment INDs are made available to participants before general marketing begins, typically during Phase III studies. To be considered for a treatment IND, a participant cannot be eligible to be in the definitive clinical trial.

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