Glossary

Adverse effect

See side effect

Adverse Event Expedited Reporting System (AdEERS)

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 the NCI and the FDA.

Agent

In a cancer clinical trial, an agent is a substance that researchers believe might be capable of producing an effect that fights cancer.

Audit

In clinical trials, the onsite monitoring of trial procedures, documents and data.

Clinical research associate (CRA)

The CRA implements and manages the protocol and educates staff, Participants and referring health care providers about the details of the trial. Often a nurse, this person assists in patient screening and scheduling, facilitates informed consent, organizes drug dispensing and specimen collection, and assists with toxicity and response monitoring, quality assurance, audits and data management.

Code of Federal Regulations (CFR)

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration. Each title (or volume) of the CFR is revised once each calendar year. A revised Title 21 is issued on approximately April 1st of each year. Part 50 and 56 of the CFR deal with protection of human subjects and IRB regulations respectively, part 312 deals with investigational new drugs.

Common Rule

The Federal Policy for the Protection of Human Subjects was adopted in 1991 and covers research supported by the Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, and HHS as well as NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product Safety Commission. The provisions are identical to the DHHS Regulations (45 CFR 46, Subpart A).

Common toxicity criteria (CTC)

A Web-based, interactive application that uses standardized language to identify and grade adverse events in cancer clinical trials.

Control group

In a clinical trial, the group that receives the accepted standard intervention being studied. In cases where no standard intervention yet exists for a particular condition, the control group would receive no intervention. No patient is placed in a control group without intervention if there is any beneficial intervention known for that patient. This group is compared to the group that receives the investigational intervention. (See also investigational group).

Cooperative groups

Networks of institutions that jointly carry out large clinical trials following the same protocol.

DHHS

One of the largest federal agencies, the U.S. Department of Health & Human Services is the principal agency for protecting the health of all Americans. Comprising 12 operating divisions, HHS' responsibilities include public health, biomedical research, Medicare and Medicaid, welfare, social services, and more. An overview of the department is provided in the document, "HHS: What We Do" at http://www.hhs.gov/about/profile.html.

Data and 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.

Data manager

The data manager manages clinical trial data, including electronic data entry, collaborates with the principal investigator and clinical coordinator on what data will be tracked, and provides data to monitoring agencies.

Early detection trials

See screening trials.

Eligibility criteria (requirements)

Participant eligibility criteria for clinical trials can range from general (age, sex, type of cancer), to specific (prior treatment, tumor characteristics, blood cell counts, and organ function). Eligibility criteria may also vary with trial phase.

Food and Drug Administration (FDA)

A consumer protection agency of the U.S. Department of Health & Human Services, the FDA is required by law to review all test results for new drugs to ensure that they are safe and effective for specific uses.

GOG (Gynecologic Oncology Group)

One of ten groups in the Clinical Trials Cooperative Group Program.

Good clinical practices (GCPs)

FDA regulations define GCPs in the clinical research process. GCPs are recommended for all investigators and those involved at the site of the trial. GCPs specify obtaining Participant informed consent , and delineate specifics for maintaining records, adverse event reporting, and laboratory accreditation.

Informed consent

The process of providing all relevant information about the trial's purpose, risks, benefits, alternatives, and procedures to a potential Participant, who then, consistent with his or her own interests and circumstances, makes an informed decision about whether to participate.

Institutional Review Board (IRB)

A board designed to oversee the research process in order to protect Participant safety. Made up of researchers, ethicists, and laypeople from the community, the board must review the trial protocols and the informed consent forms Participants sign.

Investigational group

In a clinical trial, the group that receives the new agent or intervention being tested. (See also control group).

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.

National Cancer Institute (NCI)

The National Cancer Institute, part of the National Institutes of Health of the U.S. Department of Health & Human Services, is the federal government's principal agency for cancer research. The NCI conducts, coordinates, and funds cancer research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer. Access the NCI Web site at http://www.cancer.gov.

NCI-Designated Cancer Centers

There are three kinds of NCI-designated cancer centers:

1. Comprehensive cancer centers, which conduct basic, clinical, and preventive research programs, as well as community outreach and education programs
2. Clinical cancer centers, which conduct primarily clinical research programs but may have programs in other research areas as well
3. Cancer centers (formerly called Basic Science Cancer Centers), which conduct basic or preventive research programs and do not have clinical programs

National Institutes of Health (NIH)

National Institutes of Health is the focal point of biomedical research in the United States. The NIH conducts research in it's own laboratories; supports the research of non-federal scientists in universities, medical schools, hospitals and research institutions throughout the country and abroad; helps in training research investigators; and fosters communication of medical information. The NIH Web site is accessible at www.nih.gov.

New Drug Application (NDA)

The application filed with the FDA by the trial sponsor once a trial has generated adequate data to support a certain indication for a drug.

Oncologist

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.

Phase 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 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 trial

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 intervention being tested.

Phase 4 trial

Phase 4 trials are used to evaluate the long-term safety and effectiveness of an intervention. Less common than phase 1, 2, and 3 trials, phase 4 trials take place after the new intervention has been approved for standard use.

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.

Placebo

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 intervention will be effective.)

Prevention 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 investigator (Clinical Trials Investigator)

The person responsible for overseeing all aspects of a clinical trial, specifically, for developing the concept of the trial and writing the protocol; submitting the protocol for institutional review board approval; recruiting Participants; obtaining informed consent; and collecting, analyzing, interpreting, and presenting data.

Protocol

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.

RTOG (Radiation Therapy Oncology Group)

One of ten groups in the Clinical Trials Cooperative Group Program.

Radiation 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.

Randomization

A method used to prevent bias in research. A computer or a table of random numbers generates intervention assignments, and Participants have an equal chance to be assigned to one of two or more groups (e.g., the control group or the investigational group).

Randomized clinical trial

A study in which the Participants are assigned by chance to separate groups that compare different interventions; 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 interventions they receive can be compared objectively. At the time of the trial, it is not known which intervention is best. It is the patient's choice to be in a randomized trial.

Recurrence

The return of cancer, at the same site as the original (primary) tumor or in another location, after the tumor had disappeared.

Remission

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.

Research team

The team of individuals involved in implementing a clinical trial. Typical research teams include a principal investigator, clinical research coordinator and/or research nurse, data manager, staff nurses, and pharmacists.

Screening 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.

Side effects

Problems that occur when intervention affects healthy cells. Common side effects of cancer intervention are fatigue, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

Site visit

Clinical trial sponsors (like the NCI or pharmaceutical companies) ensure the quality of data collected by performing periodic on-site visits conducted by monitors. The monitors review trial procedures, documents, and data.

Special Access Treatment programs

This program allows access to investigational drugs for use outside of a clinical trial. Working with the NCI and other sponsors, the FDA established special conditions under which a person with cancer can receive unapproved cancer drugs, which have shown clinical benefit.

Stage

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 treatment

A currently accepted and widely used treatment for a certain type of cancer, based on the results of past research.

Statistically 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.

Toxicity

Harmful side effects from an agent being tested.

Treatment group

See investigational group and control group.

Treatment 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.

Tuskegee Syphilis Study

A study conducted from 1932 to 1972 in which poor black men with syphilis were followed, but not treated for their disease, without their knowledge or consent. Despite the discovery in the 1940's that penicillin was an effective treatment for the disease, the researchers never informed or treated the men being observed.

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