clinical trial glossary

GLOSSARY GLOSSARY GLOSSARY GLOSSARY

Adverse Drug Reaction (ADR)Adverse Drug Reaction (ADR)Adverse Drug Reaction (ADR)Adverse Drug Reaction (ADR)

In the pre-approval clinical experience with a new medicinal product

or a product’s new usages, particularly as the therapeutic dose(s)

may not be established: all noxious and unintended responses to a

medicinal product related to any dose should be considered adverse

drug reactions (the phrase ‘responses to a medicinal product’

meaning that a causal relationship between a medicinal product and

an adverse event is at least a reasonable possibility, i.e. the

relationship cannot be ruled out).Regarding marketed medicinal

products: a response to a drug which is noxious and unintended and

which occurs at doses normally used in man for prophylaxis,

diagnosis, or therapy of diseases or for modification of physiological

function.

Adjuvant TherapyAdjuvant TherapyAdjuvant TherapyAdjuvant Therapy

One or more anticancer drugs used in combination with surgery or

radiation therapy as part of the treatment of cancer. Adjuvant

therapy is given before or after the primary treatment to increase the

chances of a cure. Adjuvant usually means “in addition to” initial

treatment.

Adverse Event Expedited Reporting SystemAdverse Event Expedited Reporting SystemAdverse Event Expedited Reporting SystemAdverse Event Expedited Reporting System

A Web-based program that enables researchers using NCI-sponsored

investigational agents to expedite the reporting of serious and/or

unexpected adverse events directly to NCI and FDA.

AgentAgentAgentAgent

In a cancer clinical trial, an agent is a substance that researchers

believe might be capable of producing an effect that fights cancer.

AssentAssentAssentAssent

Children and adolescents are not deemed capable of giving true

informed consent, so they are asked for their assent, or agreement,

to participation in a clinical trial

Adverse event (AE)Adverse event (AE)Adverse event (AE)Adverse event (AE)

Any untoward medical occurrence in a patient or clinical

investigation subject administered a pharmaceutical product which

does not necessarily have a causal relationship with this treatment.

An adverse event (AE) can therefore be any unfavorable and

unintended sign (including an abnormal laboratory finding), symptom,

or disease temporally associated with the use of a medicinal

(investigational) product, whether or not related to the medicinal

(investigational) product.

Applicable regulatory requirement(s)Applicable regulatory requirement(s)Applicable regulatory requirement(s)Applicable regulatory requirement(s)

Any law(s) and regulation(s) addressing the conduct of clinical trials

of investigational products.

Approval (Approval (Approval (Approval (in relation to Institutional Review Boards)in relation to Institutional Review Boards)in relation to Institutional Review Boards)in relation to Institutional Review Boards)

The affirmative decision of the Institutional Review Board (IRB) that

the clinical trial has been reviewed and may be conducted at the

institution site within the constraints set forth by the IRB, the

institution, Good Clinical Practice (GCP), and the applicable

regulatory requirements.

AuditAuditAuditAudit

A systematic and independent examination of trial-related activities

and documents to determine whether the evaluated trial-related

activities were conducted, and the data recorded, analyzed and

accurately reported, according to the protocol, sponsor's SOPs, GCP,

and the applicable regulatory requirement(s).

BlindingBlindingBlindingBlinding

A procedure in which one or more parties to the trial are kept

unaware of the treatment assignment(s).Single-blinding usually refers

to the subject(s) being unaware, and double-blinding usually refers to

the subject(s), investigator(s), monitor, and, in some cases, data

analyst(s), being unaware of the treatment assignment(s).

Belmont ReportBelmont ReportBelmont ReportBelmont Report

A 1979 report by the National Commission for the Protection of

Human Subjects of Biomedical and Behavioral Research that

delineated the ethical principles upon which today’s regulations

regarding research participants in the United States are

based: respect for persons, beneficence, and justice.

BiasBiasBiasBias

Human choices, beliefs, or any other factors besides those being

studied that affect a clinical trial’s results. Clinical trials use many

methods to avoid bias because biased results may not be correct.

Biological therapyBiological therapyBiological therapyBiological therapy

Treatment to stimulate or restore the ability of the immune system to

fight infection and disease. Also used to lessen side effects that may

be caused by some cancer treatments. Also known as Immuno -

therapy, biotherapy, or biological response modifier (BRM) therapy.

CancerCancerCancerCancer

A term for diseases in which abnormal cells divide without

control. Cancer cells can invade nearby tissues and can spread

through the bloodstream and lymphatic system to other parts of the

body.

cancer vaccinecancer vaccinecancer vaccinecancer vaccine

A form of biological therapy, which may encourage a person’s

immune system to recognize cancer cells. These vaccines may help

the body reject tumors and prevent cancer from recurring.

ChemopreventionChemopreventionChemopreventionChemoprevention

The use of drugs, vitamins, or other agents to try to reduce the risk

of, or delay the development or recurrence of, cancer.

ChemotherapyChemotherapyChemotherapyChemotherapy

Treatment with anticancer drugs.

combination chemotherapycombination chemotherapycombination chemotherapycombination chemotherapy

Treatment using more than one anticancer drug.

combination therapycombination therapycombination therapycombination therapy

The use of two or more modes of treatment—surgery, radiotherapy,

chemotherapy, immunotherapy—in combination or alternately to

achieve optimum results against cancer.

Common Toxicity CriteriaCommon Toxicity CriteriaCommon Toxicity CriteriaCommon Toxicity Criteria

A Web-based, interactive application that uses standardized

language to identify and grade adverse events in cancer clinical

trials.

confconfconfconfidence intervalsidence intervalsidence intervalsidence intervals

These reflect a range of values surrounding the true score that would

be obtained if everyone with a particular cancer were treated with

the treatment under study. The wider the interval, the more variable

the result and the less likely it is to be close to the true score.

Confidence intervals are typically thought of as the approximate

bounds or limits surrounding the true score. Researchers frequently

use either a 95 or a 99 percent confidence interval.

control groupcontrol groupcontrol groupcontrol group

In a clinical trial, the group that receives the accepted standard

treatment being studied. In cases where no standard treatment yet

exists for a particular condition, the control group would receive no

treatment. No patient is placed in a control group without treatment

if there is any beneficial treatment known for that patient. This group

is compared to the group that receives the investigational treatment.

cooperative groupscooperative groupscooperative groupscooperative groups

Networks of institutions that jointly carry out large clinical trials

following the same protocols.

Case Report Form (CRF)Case Report Form (CRF)Case Report Form (CRF)Case Report Form (CRF)

A printed, optical, or electronic document designed to record all of

the protocol required information to be reported to the sponsor on

each trial subject.

Clinical trial/studyClinical trial/studyClinical trial/studyClinical trial/study

Any investigation in human subjects intended to discover or verify

the clinical, Pharmacological and/or other pharmacodynamic effects

of an investigational product(s), and/or to identify any adverse

reactions to an investigational product(s), and/or to study absorption,

distribution, metabolism, and excretion of an investigational

product(s) with the object of ascertaining its safety and/or efficacy.

The terms clinical trial and clinical study are synonymous.

Clinical trial/study reportClinical trial/study reportClinical trial/study reportClinical trial/study report

A written description of a trial/study of any therapeutic, prophylactic,

or diagnostic agent conducted in human subjects, in which the

clinical and statistical description, presentations, and analyses are

fully integrated into a single report .

Compliance (in relation to trials)Compliance (in relation to trials)Compliance (in relation to trials)Compliance (in relation to trials)

Adherence to all the trial-related requirements, Good Clinical

Practice (GCP) requirements, and the applicable regulatory

requirements.

ConfidentialityConfidentialityConfidentialityConfidentiality

Prevention of disclosure, to other than authorized individuals, of a

sponsor's proprietary information or of a subject's identity.

ContractContractContractContract

A written, dated, and signed agreement between two or more

involved parties that sets out any arrangements regarding delegation

and distribution of tasks and obligations and, if appropriate, financial

matters. The protocol may serve as the basis of a contract.

Direct accessDirect accessDirect accessDirect access

Permission to examine, analyze, verify, and reproduce any records

and reports that are important to evaluation of a clinical trial. Any

party (e.g. domestic and foreign regulatory authorities, sponsor's

monitors and auditors) with direct access should take all reasonable

precautions within the constraints of the applicable regulatory

requirement(s) to maintain the confidentiality of subjects' identities

and the sponsor’s proprietary information.

DocumentationDocumentationDocumentationDocumentation

All records, in any form (including, but not limited to, written,

electronic, magnetic, and optical records, and scans, x-rays, and

electrocardiograms) that describe or record the methods, conduct,

and/or results of a trial, the factors affecting a trial, and the actions

taken.

Data anData anData anData and safety monitoring board (DSMB)d safety monitoring board (DSMB)d safety monitoring board (DSMB)d safety monitoring board (DSMB)

An independent committee whose membership includes, at minimum,

a statistician and a clinical expert in the area being studied.

Members may also include bioethicists or other clinicians

knowledgeable about the trial’s subject matter. The National

Institutes of Health requires DSMB review of all phase 3 clinical

trials. A DSMB might also review phase 1 or 2 trials that are blinded,

take place at multiple locations, or employ particularly high-risk

interventions or vulnerable populations.

Diagnostic trialDiagnostic trialDiagnostic trialDiagnostic trial

A research study that evaluates methods of detecting disease.

DiseaseDiseaseDiseaseDisease----free survivalfree survivalfree survivalfree survival

The amount of time a participant survives without cancer occurring

or recurring, usually measured in months.

DDDDoubleoubleoubleouble----blindedblindedblindedblinded

A clinical trial in which neither the medical staff nor the person

knows which of several possible therapies the person is receiving.

Essential documentsEssential documentsEssential documentsEssential documents

Documents which individually and collectively permit evaluation of

the conduct of a study and the quality of the data produced.

Eligibility criteriaEligibility criteriaEligibility criteriaEligibility criteria

Participant eligibility criteria for clinical trials can range from general

(age, sex, type of cancer) to specific (prior treatment, tumor

characteristics, blood cell counts, organ function). Eligibility criteria

may also vary with trial phase. In phase 1 and 2 trials, the criteria

often focus on making sure that people who might be harmed

because of abnormal organ function or other factors are not put at

risk. Phase 2 and 3 trials often add criteria regarding disease type

and stage, and number of prior treatments.

EndpointEndpointEndpointEndpoint

What researchers measure to evaluate the results of a new treatment

being tested in a clinical trial. Research teams establish the

endpoints of a trial before it begins. Examples of endpoints include

toxicity, tumor response, survival time, and quality of life.

Food and Drug Administration (FDA)Food and Drug Administration (FDA)Food and Drug Administration (FDA)Food and Drug Administration (FDA)

A consumer protection agency of the U.S. Department of Health and

Human Services, FDA is required by law to review all test results for

new drugs to ensure that they are safe and effective for specific

uses.

Good Clinical Practice (GCP)Good Clinical Practice (GCP)Good Clinical Practice (GCP)Good Clinical Practice (GCP)

A standard for the design, conduct, performance, monitoring,

auditing, recording, analyses, and reporting of clinical trials that

provides assurance that the data and reported results are credible

and accurate, and that the rights, integrity, and confidentiality of trial

subjects are protected.

GeneGeneGeneGene

The functional and physical unit of heredity passed from parent to

offspring. Genes are pieces of DNA, and most genes contain the

information for making a specific protein.

Gene therapyGene therapyGene therapyGene therapy

Treatment that alters a gene. In studies of gene therapy for cancer,

researchers are trying to improve the body’s natural ability to fight

the disease or to make the cancer cells more sensitive to other kinds

of therapy.

GeneticGeneticGeneticGenetic

Inherited; having to do with information that is passed from parents

to offspring through genes in sperm and egg cells.

Genetic epidemiologic researchGenetic epidemiologic researchGenetic epidemiologic researchGenetic epidemiologic research

Research that involves looking at tissue or blood samples from large

populations of people in order to determine how one’s genetic make-

up can influence detection, diagnosis, prognosis, and ultimately,

treatment.

Genetics trialsGenetics trialsGenetics trialsGenetics trials

Clinical trials that examine whether gene transfer therapy can be

used to treat cancer, or whether genetic epidemiology research

improves the understanding of cancer at the cellular level. Actual

genetic intervention (such as gene transfer) trials are few in number,

however trials are underway where actual cellular manipulation at

the gene level occurs.

Investigational new drug (IND)Investigational new drug (IND)Investigational new drug (IND)Investigational new drug (IND)

A drug that the Food and Drug Administration (FDA) allows to be used

in clinical trials but that the FDA has not approved for commercial

marketing.

Impartial witnessImpartial witnessImpartial witnessImpartial witness

A person, who is independent of the trial, who cannot be unfairly

influenced by people involved with the trial, who attends the

informed consent process if the subject or the subject’s legally

acceptable representative cannot read, and who reads the informed

consent form and any other written information supplied to the

subject.

Independent Ethics Committee (IEC)Independent Ethics Committee (IEC)Independent Ethics Committee (IEC)Independent Ethics Committee (IEC)

An independent body (an institutional, regional, national, or

supranational review board or committee), constituted of medical

professionals and non-medical members, whose Responsibility it is to

ensure protection of the rights, safety and well-being of human

subjects involved in a trial and to provide public assurance of that

protection, by, among other things, reviewing and proving/providing

favorable opinion on the trial protocol, suitability of the

investigator(s), facilities, and methods and materials to be used in

obtaining and documenting informed consent of the trial subjects.

The legal status, composition, function, operations and regulatory

requirements pertaining to Independent Ethics Committees may

differ among countries, but should allow the Independent Ethics

Committee to act in agreement with GCP as described in this

guideline.

Informed consentInformed consentInformed consentInformed consent

A process by which a subject voluntarily confirms his or her

willingness to participate in a particular trial, after having been

informed of all aspects of the trial that are relevant to the subject's

decision to participate. Informed consent is documented by means of

a written, signed and dated informed consent form.

InspectionInspectionInspectionInspection

The act by a regulatory authority(ies) of conducting an official review

of documents, facilities, records, and any other resources that are

deemed by the authority(ies) to be related to the clinical trial and

that may be located at the site of the trial, at the sponsor's and/or

contract research organization’s (CRO’s) facilities, or at other

establishments deemed appropriate by the regulatory authority(ies).

Institution (medical)Institution (medical)Institution (medical)Institution (medical)

Any public or private entity or agency or medical or dental facility

where clinical trials are conducted.

Institutional Review Board (IRB)Institutional Review Board (IRB)Institutional Review Board (IRB)Institutional Review Board (IRB)

An independent body constituted of medical, scientific, and non-

scientific members, whose responsibility is to ensure the protection

of the rights, safety and well-being of human subjects involved in a

trial by, among other things, reviewing, approving, and providing

continuing review of trial protocol and amendments and of the

methods and materials to be used in obtaining and documenting

informed consent of the trial subjects.

Interim clinical trial/study rInterim clinical trial/study rInterim clinical trial/study rInterim clinical trial/study reporteporteporteport

A report of intermediate results and their evaluation based on

analyses performed during the course of a trial.

Investigational productInvestigational productInvestigational productInvestigational product

A pharmaceutical form of an active ingredient or placebo being

tested or used as a reference in a clinical trial, including a product

with a marketing authorization when used or assembled (formulated

or packaged) in a way different from the approved form, or when used

for an unapproved indication, or when used to gain further

information about an approved use.

InveInveInveInvestigatorstigatorstigatorstigator

A person responsible for the conduct of a clinical trial at a trial site.

If a trial is conducted by a team of individuals at a trial site, the

investigator is the responsible leader of the team and may be called

the Principal Investigator. See also Sub-investigator.

Investigator/institutionInvestigator/institutionInvestigator/institutionInvestigator/institution

An expression meaning ‘the investigator and/or institution, where

required by the applicable regulatory requirements’.

Investigator's Brochure (IB)Investigator's Brochure (IB)Investigator's Brochure (IB)Investigator's Brochure (IB)

A compilation of the clinical and nonclinical data on the

investigational product(s) relevant to the study of the investigational

product(s) in human subjects.

Legally acceptable representativeLegally acceptable representativeLegally acceptable representativeLegally acceptable representative

An individual or juridical or other body authorized under applicable

law to consent, on behalf of a prospective subject, to the subject's

participation in the clinical trial.

MonitoringMonitoringMonitoringMonitoring

The act of overseeing the progress of a clinical trial, and of ensuring

that it is conducted, recorded, and reported in accordance with the

protocol, Standard Operating Procedures (SOPs), Good Clinical

Practice (GCP), and applicable regulatory requirement(s).

Monitoring reportMonitoring reportMonitoring reportMonitoring report

A written report from the monitor to the sponsor after each site visit

and/or other trial-related communication according to the sponsor’s

SOPs.

Multicentre trialMulticentre trialMulticentre trialMulticentre trial

A clinical trial conducted according to a single protocol but at more

than one site, and therefore carried out by more than one

investigator.

MetastasisMetastasisMetastasisMetastasis

The spread of cancer from one part of the body to another. In cancer,

metastasis is the migration of cancer cells from the original tumor

site through the blood and lymph vessels to produce cancers in other

tissues. Tumors formed from cells that have spread are called

“secondary tumors” and contain cells that are like those in the

original (primary) tumor. The plural is metastases.

Metastatic cancerMetastatic cancerMetastatic cancerMetastatic cancer

Cancer that has spread from the place in which it started to other

parts of the body.

Monoclonal AntibodiesMonoclonal AntibodiesMonoclonal AntibodiesMonoclonal Antibodies

Laboratory-produced substances that can locate and bind to cancer

cells wherever they are in the body. Many monoclonal antibodies are

used in cancer detection or therapy; each one recognizes a different

protein on certain cancer cells. Monoclonal antibodies can be used

alone, or they can be used to deliver drugs, toxins, or radioactive

material directly to a tumor.

Multimodality TherapyMultimodality TherapyMultimodality TherapyMultimodality Therapy

Therapy that combines more than one method of treatment.

New Drug Application (NDA)New Drug Application (NDA)New Drug Application (NDA)New Drug Application (NDA)

The application filed with FDA by the trial sponsor once a trial has

generated adequate data to support a certain indication for a drug.

OncologistOncologistOncologistOncologist

A doctor who specializes in treating cancer. Some oncologists

specialize in a particular type of cancer treatment. For example, a

radiation oncologist specializes in treating cancer with radiation.

Opinion (in relation to Independent EthicsOpinion (in relation to Independent EthicsOpinion (in relation to Independent EthicsOpinion (in relation to Independent Ethics Committee) Committee) Committee) Committee)

The judgment and/or advice provided by an Independent Ethics

Committee (IEC).

Subject/trial subjectSubject/trial subjectSubject/trial subjectSubject/trial subject

An individual who participates in a clinical trial, either as a recipient

of the investigational product(s) or as a control.

Subject identifSubject identifSubject identifSubject identification codeication codeication codeication code

A unique identifier assigned by the investigator to each trial subject

to protect the subject's identity and used in lieu of the subject's

name when the investigator reports adverse events and/or other trial

related data.

pppp----valuevaluevaluevalue

A statistics term. A measure of probability that a difference between

groups during an experiment happened by chance. For example, a p-

value of .01 (p = .01) means there is a 1 in 100 chance the result

occurred by chance. The smaller the p-value, the more likely it is that

the difference between groups was caused by a difference between

the tested treatments.

Peer ReviewPeer ReviewPeer ReviewPeer Review

Scientific review by a panel of experts. The primary responsibility of

these experts is to assess the scientific and technical merit of

research proposals.

PharmacokineticsPharmacokineticsPharmacokineticsPharmacokinetics

The activity of drugs in the body over a period of time, including the

processes by which drugs are absorbed, distributed in the body,

localized in the tissues, and excreted.

Phase 1 trialPhase 1 trialPhase 1 trialPhase 1 trial

Small groups of people with cancer are treated with a certain dose of

a new agent that has already been extensively studied in the

laboratory. During the trial, the dose is usually increased group by

group in order to find the highest dose that does not cause harmful

side effects. This process determines a safe and appropriate dose to

use in a phase 2 trial.


Phase 2 trials continue to test the safety of the new agent and begin

to evaluate how well it works against a specific type of cancer. In

these trials, the new agent is given to groups of people with one type

of cancer or related cancers, using the dosage found to be safe in

phase 1 trials.


Phase 3 trials are designed to answer research questions across the

disease continuum. Phase 3 trials usually have hundreds to

thousands of participants, in order to find out if there are true

differences in the effectiveness of the treatment being tested.


Phase 4 trials are used to evaluate the long-term safety and

effectiveness of a treatment. Less common than phase 1, 2, and 3

trials, phase 4 trials take place after the new treatment has been

approved for standard use.

Physician Data Query (PDQ®)Physician Data Query (PDQ®)Physician Data Query (PDQ®)Physician Data Query (PDQ®)

PDQ is an online database developed and maintained by the National

Cancer Institute. Designed to make the most current, credible, and

accurate cancer information available to health professionals and the

public, PDQ contains peer-reviewed summaries on cancer treatment,

screening, prevention, genetics, and supportive care; a registry of

cancer clinical trials from around the world; and directories of

physicians, professionals who provide genetics services, and

organizations that provide cancer care.

PlaceboPlaceboPlaceboPlacebo

An inactive substance that looks the same as, and is administered in

the same way as, a drug in a clinical trial. A placebo may be

compared with a new drug when no one knows if any drug or

treatment will be effective.

Preclinical testingPreclinical testingPreclinical testingPreclinical testing

A process in which scientists test promising new cancer treatments

in the laboratory and in animal models. This is done to find out

whether agents have an anticancer effect and are safely tolerated in

animals. Once an agent proves promising in the lab, the sponsor

applies for Food and Drug Administration approval to test it in clinical

trials involving people.

Prevention trialsPrevention trialsPrevention trialsPrevention trials

Trials involving healthy people who are at high risk for developing

cancer. These trials try to answer specific questions about and

evaluate the effectiveness of ways to reduce the risk of cancer.

Principal InvestigatorPrincipal InvestigatorPrincipal InvestigatorPrincipal Investigator

The person responsible for overseeing all aspects of a clinical trial,

specifically, for developing the concept and writing the protocol;

submitting the protocol for institutional review board approval;

recruiting participants; obtaining informed consent; and collecting,

analyzing, interpreting, and presenting data.

ProtocolProtocolProtocolProtocol

A written, detailed action plan for a clinical trial. The protocol

provides the background, specifies the objectives, and describes the

design and organization of the trial. Every center participating in the

trial uses the same protocol, ensuring consistency of procedures and

enhancing communication among everyone working on the trial. This

uniformity ensures that participant information from all centers can

be combined and compared.

Protocol amendmentProtocol amendmentProtocol amendmentProtocol amendment

A written description of a change(s) to, or formal clarification of, a

protocol.

Quality assurance (QA)Quality assurance (QA)Quality assurance (QA)Quality assurance (QA)

All those planned and systematic actions that are established to

ensure that a trial is performed and data generated, documented

(recorded), and reported in compliance with Good Clinical Practice

(GCP) and applicable regulatory requirement(s).

Quality control (QC)Quality control (QC)Quality control (QC)Quality control (QC)

The operational techniques and activities undertaken within the

quality assurance system to verify that the requirements for quality

of the trial-related activities have been fulfilled.

RandomizationRandomizationRandomizationRandomization

The process of assigning trial subjects to treatment or control groups

using an element of chance to determine the assignments in order to

reduce bias.

Regulatory authoritiesRegulatory authoritiesRegulatory authoritiesRegulatory authorities

Bodies having the power to regulate. In the ICH GCP guideline the

expression ‘Regulatory authorities’ includes the authorities that

review submitted clinical data and those that conduct inspections.

These bodies are sometimes referred to as competent authorities.

Radiation TherapyRadiation TherapyRadiation TherapyRadiation Therapy

The use of high-energy radiation from x-rays, gamma rays, neutrons,

and other sources to kill cancer cells and shrink tumors. Radiation

may come from a machine outside the body (external-beam radiation

therapy), or it may come from radioactive material placed in the body

in the area near cancer cells (internal radiation therapy, implant

radiation, or brachytherapy). Systemic radiation therapy uses a

radioactive substance, such as a radiolabeled monoclonal antibody,

that circulates throughout the body. Also called radiotherapy.

Randomized clinical trialRandomized clinical trialRandomized clinical trialRandomized clinical trial

A study in which the participants are assigned by chance to separate

groups that compare different treatments; neither the researchers

nor the participants can choose which group. Using chance to assign

people to groups means that the groups will be similar and that the

treatments they receive can be compared objectively. At the time of

the trial, it is not known which treatment is best. It is the patient’s

choice to be in a randomized trial.

RegimenRegimenRegimenRegimen

A treatment plan that specifies the dosage, the schedule, and the

duration of treatment.

RegressionRegressionRegressionRegression

A decrease in the size of a tumor, or in the extent of cancer in the

body.

Relative riskRelative riskRelative riskRelative risk

In cancer treatment trials, the likelihood that cancer will recur within

a specific timeframe in one intervention group versus another.

RemissionRemissionRemissionRemission

A decrease in or disappearance of signs and symptoms of cancer. In

partial remission, some, but not all, signs and symptoms of cancer

have disappeared. In complete remission, all signs and symptoms of

cancer have disappeared, although there still may be cancer in the

body.

Risk/benefit ratioRisk/benefit ratioRisk/benefit ratioRisk/benefit ratio

The relation between the risks and benefits of a given treatment or

procedure. An institutional review board, usually located where the

clinical trial is to take place, determines whether the risks in the trial

are reasonable with respect to the potential benefits. It is up to

individual potential participants to decide whether it is reasonable

for them in particular to participate.

Serious Adverse EveSerious Adverse EveSerious Adverse EveSerious Adverse Event (SAE) or Serious Adverse Drug nt (SAE) or Serious Adverse Drug nt (SAE) or Serious Adverse Drug nt (SAE) or Serious Adverse Drug

Reaction (Serious ADR)Reaction (Serious ADR)Reaction (Serious ADR)Reaction (Serious ADR)

Any untoward medical occurrence that, at any dose:

- results in death,

- is life-threatening,

- requires inpatient hospitalization or prolongation of existing

hospitalization,

- results in persistent or significant disability/incapacity,

or

- is a congenital anomaly/birth defect

- results in important medical events that may not be immediately

life-threatening or results in death or hospitalization but may

jeopardize the patient or may require intervention to prevent the

other outcomes listed above.

Source dataSource dataSource dataSource data

All information in original records and certified copies of original

records of clinical findings, observations, or other activities in a

clinical trial necessary for the reconstruction and evaluation of the

trial. Source data are contained in source documents (original

records or certified copies).

Source documentsSource documentsSource documentsSource documents

Original documents, data, and records (e.g. hospital records, clinical

and office charts, laboratory notes, memoranda, subjects' diaries or

evaluation checklists, pharmacy dispensing records, recorded data

from automated instruments, copies or transcriptions certified after

verification as being accurate copies, microfiches, photographic

negatives, microfilm or magnetic media, x-rays, subject files, and

records kept at the pharmacy, laboratories and medico-technical

departments involved in the clinical trial).

SponsorSponsorSponsorSponsor

An individual, company, institution, or organization which takes

responsibility for the initiation, management, and/or financing of a

clinical trial.

Standard Operating Procedures (SOPs)Standard Operating Procedures (SOPs)Standard Operating Procedures (SOPs)Standard Operating Procedures (SOPs)

Detailed, written instructions to achieve uniformity of performance of

a specific function.

Study site/Trial siteStudy site/Trial siteStudy site/Trial siteStudy site/Trial site

The location(s) where trial-related activities are actually conducted .

SubSubSubSub----investigatorinvestigatorinvestigatorinvestigator

Any individual member of the clinical trial team designated and

supervised by the investigator at a trial site to perform critical trial-

related procedures and/or make important trial-related decisions (e.g.

associates, residents, research fellows). See also Investigator.

Sample sizeSample sizeSample sizeSample size

In clinical trials, the number of people participating in a trial.

Screening trialsScreening trialsScreening trialsScreening trials

Clinical trials that assess the effectiveness of new means of

detecting cancer early in healthy people, especially the earliest

stages of cancer. For many types of cancer, early detection results in

improved outcomes. In addition, these trials examine whether early

treatment, as a result of early detection, actually improves overall

survival or disease-free survival.

SiSiSiSide effectsde effectsde effectsde effects

Problems that occur when treatment affects healthy cells. Common

side effects of cancer treatment are fatigue, nausea, vomiting,

decreased blood cell counts, hair loss, and mouth sores.

SingleSingleSingleSingle----blindedblindedblindedblinded

Describes clinical trials set up in such a way that participants do not

know which therapy or intervention they are receiving.

StageStageStageStage

The extent of a cancer, especially whether the disease has spread

from the original site to other parts of the body. Numbers with or

without letters are used to define cancer stages (e.g., stage IIb).

Standard treatmentStandard treatmentStandard treatmentStandard treatment

A currently accepted and widely used treatment for a certain type of

cancer, based on the results of past research.

Statistical powerStatistical powerStatistical powerStatistical power

The chance of getting a statistically significant result when there is

one. Ideally, in clinical trials statistical power should be .80 or .90––in

other words, there is an 80 to 90 percent chance that the true

difference in effectiveness between the treatments is the smallest

size considered medically important to detect.

Statistically significantStatistically significantStatistically significantStatistically significant

Describes a mathematical measure of difference between groups.

The difference is said to be statistically significant if it is greater

than what might be expected to happen by chance alone.

StratificationStratificationStratificationStratification

A separation process used in randomized trials when factors that

can influence the intervention’s success are known. For example,

participants whose cancer has spread from the original tumor site

can be separated, or stratified, from those whose cancer has not

spread. Assignment of interventions within the two groups is then

randomized. Stratification enables researchers to look in separate

subgroups to see whether differences exist.

Trial site/Study siteTrial site/Study siteTrial site/Study siteTrial site/Study site

The location(s) where trial-related activities are actually conducted.

ToxicityToxicityToxicityToxicity

Harmful side effects from an agent being tested.

Treatment trialsTreatment trialsTreatment trialsTreatment trials

Treatment trials are designed to test the safety and effectiveness of

new drugs, biological agents, techniques, or other interventions in

people who have been diagnosed with cancer. These trials evaluate

the novel treatment against standard treatment, if there is one.

TumorTumorTumorTumor

An abnormal mass of tissue that results from excessive cell division.

Tumors perform no useful body function. They may be benign (not

cancerous) or malignant (cancerous).

Unexpected Adverse Drug ReactionUnexpected Adverse Drug ReactionUnexpected Adverse Drug ReactionUnexpected Adverse Drug Reaction

An adverse reaction, the nature or severity of which is not consistent

with the applicable product information (e.g. Investigator's Brochure

for an unapproved investigational product or package insert/summary

of product characteristics for an approved product) .

VaccineVaccineVaccineVaccine

A substance or group of substances meant to cause the immune

system to respond to a cancer or to microorganisms, such as

bacteria or viruses.

WellWellWellWell----being (of the trial subjects)being (of the trial subjects)being (of the trial subjects)being (of the trial subjects)

The physical and mental integrity of the subjects participating in a

clinical trial.