Clinical Trials Resource Center

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A
Adverse reaction(Adverse Event.) An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time (SeeSide effects).

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

批准的药物
In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application (SeeFood and Drug Administration)

手臂Any of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more. (SeeRandomized trial).
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B
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当观点阻止对与该观点主题有关的问题的公正判断。在临床研究中，偏见是通过盲和随机分解控制的（请参阅随机化).

BlindA 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 on whether they are in the experimental or control arm of the study. (SeeSingle-blind study和Double-blind study).
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C
ClinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science.

临床终点See端点.

Clinical investigatorA medical researcher in charge of carrying out a clinical trial's protocol.

临床试验A 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 Itests a new drug or treatment in a small group;第二阶段expands the study to a larger group of people;第二阶段I将研究扩展到更大的人群；和第四阶段takes place after the drug or treatment has been licensed and marketed. (SeePhase I,II,III, andIVTrials).

CohortIn epidemiology, a group of individuals with some characteristics in common.

Community-based clinical trial (CBCT)A clinical trial conducted primarily through primary-care physicians rather than academic research facilities.

Compassionate useA 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. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy.

互补和替代疗法Broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or treat health conditions. Examples include acupuncture, herbs, etc. Internet Address:www.nccam.nih.gov

Confidentiality regarding trial participantsRefers 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当使用某些治疗可能有害时，特定的情况。

ControlA control is the nature of the intervention control.

Control groupA group of research subjects who are not treated with the investigational product. The control group may receive a comparative therapy, a placebo or may receive no treatment. The control group study results are compared to the group(s) who receive the investigational products. (SeePlacebo和标准治疗).

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.
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D
Data Safety and Monitoring Board (DSMB)An independent committee, composed of community representatives and clinical research experts, that reviews 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 trialsRefers 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 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.

Double-blind studyA 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 doctor and the participant about the experimental drug do not affect the outcome. SeeBlinded study,Single-blind study, andPlacebo.

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 apositive or negative effectthat is not normally associated with either drug.

DSMBSee Data Safety and Monitoring Board.
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E
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. In the procedure mandated by the FDA, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. (SeeFood and Drug Administration (FDA),第二阶段和IIITrials).

Eligibility criteriaSummary criteria for participant selection; includes Inclusion and Exclusion criteria. (SeeInclusion/exclusion criteria)

Empirical基于实验数据，而不是基于理论。

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

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

Exclusion/inclusion criteriaSeeInclusion/exclusion criteria.

Expanded access指任何FDA的程序,如压缩空气ssionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials.

Experimental drugA drug that is not FDA licensed for use in humans, or as a treatment for a particular condition (See标签不使用).
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F
FDASeeFood and Drug Administration.

Food and Drug Administration (FDA)
The U.S. Department 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. Internet address:www.fda.gov
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G
There are no terms beginning with the letter "G".
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H
Hypothesis
A supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation.
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I
Inclusion/exclusion criteria确定一个人是否可以或不允许进入临床试验的医学或社会标准。这些标准基于年龄，性别，疾病的类型和阶段，以前的治疗史和其他医疗状况等因素。重要的是要注意，包容和排除标准不是用来拒绝个人的，而是要确定合适的参与者并确保他们的安全。

INDSeeInvestigational New Drug.

Informed consentThe 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.

Informed consent documentA document that describes the rights of the study participants, and includes details about 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.

Institutional Review Board (IRB)1）医师，统计学家，研究人员，社区拥护者和其他委员会确保临床试验具有道德和研究参与者的权利beplay苹果手机能用吗受到保护。美国所有临床试验必须在IRB开始之前批准。2）。每个进行或支持涉及人类参与者的生物医学或行为研究的机构都必须受联邦法规的IRB，最初批准并定期审查研究以保护人类参与者的权利。beplay苹果手机能用吗

Intent to treatAnalysis of clinical trial results that includes all data from participants in the groups to which they were randomized (See随机化) even if they never received the treatment.

Intervention nameThe generic name of the precise intervention being studied.

InterventionsPrimary interventions being studied: types of interventions are Drug, Gene Transfer, Vaccine, Behavior, Device, or Procedure.

调查新药一种新的药物,抗生素药物,或生物药物that is used in a clinical investigation. It also includes a biological product used in humans for diagnostic purposes.

IRBSeeInstitutional Review Board.
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J
从字母“ J”开始，没有任何条款。
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K
There are no terms beginning with the letter "K".
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L
从字母“ L”开始，没有任何条款。
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M
Masking
Seeblind
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N
Natural history studyStudy of the natural development of something (such as an organism or a disease) over a period of time.

New Drug Application (NDA)An application submitted by the manufacturer of a drug to the FDA - after clinical trials have been completed - for a license to market the drug for a specified indication.
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O
标签不使用A drug prescribed for conditions other than those approved by the FDA.

Open-label trialA clinical trial in which doctors and participants know which drug or vaccine is being administered.

Orphan drugsAn FDA category that refers to medications used to treat diseases and conditions that occur rarely. There is little financial incentive for the pharmaceutical industry to develop medications for these diseases or conditions. Orphan drug status, however, gives a manufacturer specific financial incentives to develop and provide such medications.
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P
Peer reviewReview of a clinical trial by experts chosen by the study sponsor. These experts review the trials for scientific merit, participant safety, and ethical considerations.

PharmacokineticsThe processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.

Phase I trials最初的研究以确定药物在人类中的代谢和药理作用，与剂量增加相关的副作用以及获得有效性的早期证据；可能包括健康的参与者和/或患者。

第二阶段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.

第二阶段I trials在获得初步证据后扩展的受控和不受控制的试验表明该药物有效性。这些扩展的试验旨在收集其他信息，以评估药物的整体利益风险关系，并为医师标签提供足够的基础。

第四阶段trialsPost-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.

PlaceboA 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. (See安慰剂对照研究，below).

Placebo controlled study一种对一组参与者提供了一种非活性物质（安慰剂）的药物的研究方法，而被测试的药物则被给予另一组。然后将两组中获得的结果进行比较，以查看研究治疗在治疗病情方面是否更有效。

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.

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.

预防试验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.

协议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 (SeeInclusion/exclusion criteria).
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Q
生活质量试验（或支持性护理试验）Refers to trials that explore ways to improve comfort and quality of life for individuals with a chronic illness.
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R
随机化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 not 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 (See手臂).

Randomized trialA study in which participants are randomly (i.e., by chance) assigned to one of two or more treatment arms of a clinical trial. Occasionally placebos are utilized. (See手臂和Placebo).

Risk-benefit ratioThe risk to individual participants versus the potential benefits. The risk/benefit ratio may differ depending on the condition being treated.
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S
Screening trialsRefers to trials which test the best way to detect certain diseases or health conditions.

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 (SeeAdverse reaction).

Single-blind studyA study in which one party, either the investigator or participant, is unaware of what medication the participant is taking (SeeBlind和Double-blind study).

标准治疗目前在FDA中广泛使用和批准的治疗方法，被认为在治疗特定疾病或病情方面是有效的。

Standards of care基于最先进的参与者护理状态的治疗方案或医疗管理。

Statistical significance一个事件的概率或发生差异ed by chance 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.

Study endpointA primary or secondary outcome used to judge the effectiveness of a treatment.

Study type
Treatment trialstest experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
预防试验寻找更好的方法来预防从未患有这种疾病或预防疾病回来的人的疾病。这些方法可能包括药物，维生素，疫苗，矿物质或改变生活方式。
Diagnostic trials进行以找到更好的测试或程序来诊断特定疾病或病情。
Screening trialstest the best way to detect certain diseases or health conditions.
生活质量试验(or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
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T
毒性不利于参与者健康的药物产生的不良影响。与药物相关的毒性水平会根据药物用于治疗的状况而有所不同。

Treatment INDIND 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 U.S. 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.

Treatment trials指的是测试新疗法，新药物组合或新方法或放射治疗方法的试验。
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U
There are no terms beginning with the letter "U".
V
There are no terms beginning with the letter "V".

W
There are no terms beginning with the letter "W".

X
There are no terms beginning with the letter "X".

Y
There are no terms beginning with the letter "Y".

Z
从字母“ z”开始，没有任何条款。
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