Mesothelioma Clinical Trials Glossary

Glossary of Clinical Trials Terminology

This glossary was developed to assist the user with the definitions of some of the standard terminology employed in clinical trials.

Adverse Reaction: (Adverse Event.) An undesirable outcome induced by a dose of drugs. Such an effect may be occur suddenly or grow over a longer time period (See Side Effects).

Advocacy And Support Groups: Establishments and other personnel that aid test subjects and their families with important tools, such as self-help and life-enhancement knowledge.

Approved Drugs: In the United States, the Food and Drug Administration (FDA) has to sanction a chemical treatment as a drug prior to its release to the market. The approval procedure calls for numerous tasks, such as pre-clinical research and animal testing, clinical tests for soundness and effectiveness, lodging of a New Drug Application by the drug's maker, FDA inspection of the application, and FDA approval/disapproval of implementation for the market. (See Food and Drug Administration).

Arm: A group undergoing treatment in a trial. Almost all random trials feature two "arms," however, a few possess three "arms," or possibly more (See Randomized Trial).

Baseline: 1. Data accumulated at the outset of a trial from which deviations found in the course of the trial are evaluated. 2. An acknowledged number or measure with which a new piece of data is likened when quantified or evaluated. 3. The starting point in a clinical trial, prior to when a test subject begins to take the drug which is under testing. At this point, important values are registered. Risks and efficiency of a treatment are often ascertained by managing variances from the baseline measures.

Bias: A viewpoint that precludes fair assessment on matters pertaining to the holder of that viewpoint. In clinical trials, techniques such as blinding and randomization control the influence of bias (See Blind and Randomization).

Blind: A randomized study is "Blind" if the subject is not informed as to the arm of the study in which he is participating. A clinical trial is "Blind" if subjects are not informed if they are in the observational or control arm of the study; also called masked. (See Single Blind Study and Double Blind Study).

Clinical: Concerning or based on observance and care of subjects, as differentiated from abstract or speculative science.

Clinical Investigator: A medical research worker who oversees the implementation of a clinical trial's practices.

Clinical Trial: A clinical trial is an organized effort to resolve particular inquiries regarding drugs or new remedies or new methods of employing recognized medical practices. Clinical trials are assembled to learn if new drugs or methods are both sound and useful. Clinical trials, with careful guidance, are the smoothest and most secure method to observe medications that are effective on humans. Trials are split into four distinct phases: Phase I examines an untested pharmaceutical or method on a small scale; Phase II extends the trial to a wider group of subjects; Phase III spreads out the trial to a still more extensive group; and Phase IV occurs once the pharmaceutical or method has been authorized and made ready for the marketplace. (See Phase I, II, III, and IV Trials).

Cohort: In epidemiology, a grouping of trial subjects with similar traits (age, sex, pre-existing condition, etc...).

Community-Based Clinical Trial (CBCT): A clinical trial carried out mainly via primary-care doctors instead of through university medical centers.

Compassionate Use: A process of furnishing untested therapeutic methods before complete FDA approval for treatment in humans. This process is utilized with extremely ill persons who do not have any other available treatment choices. Frequently, individual consent must be granted by the FDA for "compassionate use" of a new treatment method.

Complementary and Alternative Therapy: Wide selection of therapeutic schools of thought, attitudes, and remedies that the scientific and medical communities traditionally don't employ to address wellness concerns. Examples include herbal supplements, massage, etc...

Completed: See Recruitment Status

Confidentiality Regarding Trial Participants: Pertains to preserving the anonymity of trial subjects, such as their identity and all medical records. The trial subjects' acceptance to the usage of records for the purposes of data confirmation should always be received before the trial and a pledge to the subject must be made that such anonymity will be observed.

Contraindication: A particular condition when the employment of particular therapies could be detrimental.

Control Group: The criterion by which data-based observances are measured. In numerous clinical trials, one collection of subjects will be administered an untested drug or therapeutic method, while the control group receives either an accepted treatment for the condition or a placebo (See Placebo and Standard Treatment).

Controlled Trials: Control is a measure that sets a baseline to compare to observations during the study. One group of subjects receives an untested drug, while another group (i.e., the control group) receives either an accepted treatment for the condition or a placebo.

Data Safety and Monitoring Board (DSMB): An autonomous committee, made up of area spokespersons and medical researchers, that examines information during a clinical trial to guarantee that subjects are protected from unwarranted hazards. A DSMB may advocate that a study be halted if safety fears arise or if the trial targets have been reached.

Diagnostic Trials: Pertains to trials that are carried out to discover more effective screens or processes for analyzing a specific illness. Diagnostic trials typically include subjects who have evidence or indications of the illness under examination.

Dose-Ranging Study: A clinical trial in which multiple doses of a drug are tried out against one another to find out which dosage level is most efficient.

Double-Blind Study: A clinical trial plan in which neither the subjects nor the trial personnel recognizes which subjects receive the drug under trial and which ones receive a placebo (or a different therapy). Double-blind trials are believed to create fair data, as the wishes of the doctor and the subject about the drug under trial do not impact the final result; also known as double-masked study. See Blinded Study, Single-Blind Study, and Placebo.

Drug-Drug Interaction: An adjustment on the outcome of a treatment when combined with another treatment. The outcome could possibly be a gain or a drop-off in the effectiveness of either chemical, or it could create an adverse effect that is not usually connected with either drug.

Efficacy: (Of a drug or treatment). The highest capability of a drug or treatment to bring about an outcome no matter the dosage. A drug accomplishes efficacy if it is useful and potent at the dosage level recommended to treat the condition for which it is under trial. In the process prescribed by the FDA, Phase II clinical trials measure efficacy, and Phase III trials substantiate it (See Food and Drug Administration (FDA), Phase II and III Trials).

Eligibility Criteria: A list of the criteria for subject eligibility; which includes Inclusion and Exclusion criteria. (See Inclusion/Exclusion Criteria)

Empirical: Supported by observational information, not on a hypothesis.

Endpoint: Final result that the trial conventions is projected to assess. Typical endpoints are severe tissue damage, worsening of the condition under trial, etc.

Enrolling: The act of contracting potential subjects into a trial. Usually this procedure calls for appraising a potential subject with regard to the eligibility standards of the trial and carrying out the informed consent process.

Epidemiology: The division of medical science that studies the occurrence, dispersion and treatment of an illness within a population. More on the epidemiology of mesothelioma.

Expanded Access: Relates to FDA procedures, including compassionate use, parallel track, and treatment IND that administer experimental drugs to subjects who are not recovering using treatments in the current market for their illness and who are also not able to take part in current clinical trials.

Experimental Drug: A drug that the FDA has not approved for treatment in humans, or as a treatment for a specific illness (See Off-Label Use).

Food and Drug Administration (FDA): A Federal agency under the Department of Health and Human Services. The FDA's main responsibility is to ascertain the effects, both beneficial and harmful, of all pharmaceuticals, biologics, vaccines, and treatment devices, such as those employed in the diagnosing, therapy, and containment of HIV infection, AIDS, and AIDS-related contagions. The FDA likewise collaborates with the blood banks to protect the nation's blood supply.

Hypothesis: A speculation or presumption brought forward as a foundation for thought or debate, or as a starting point to empirical testing.

Inclusion/Exclusion Criteria: The medical or societal criteria regulating whether a potential subject might or might not be admitted to get into a clinical trial. These measures are established on such elements as age, gender, specifics of an illness, medical history, and other health concerns. NOTE: inclusion and exclusion criteria are not exploited to rule out subjects on a personal level, but instead to distinguish suitable subjects and insure their safety.

Informed Consent: The procedure of determining the important data regarding a clinical trial prior to choosing to participate. During the study, this process stays in place to inform subjects. In order to assist a person with their decision to participate, the personnel in the trial must clearly spell out all of the particulars of the trial.

Informed Consent Document: A document that details the expectations of the trial subjects, and includes particulars regarding the trial, including its intent, length, mandatory processes, and important personnel. Hazards and likely benefits are outlined in the informed consent document. The subject then chooses if they will sign the document. Informed consent is not a legally binding contract, and the subject may leave the trial at any point.

Institutional Review Board (IRB): 1. A committee of doctors, statisticians, clinical investigators, community leaders, and others that sees to it that a clinical trial meets ethical standards and that the rights of trial subjects are secure. Each clinical trial in the U.S. must be authorized by an IRB prior to their start. 2. All institutions that carry out or financially support biomedical or behavioral experiments requiring human subjects must, by law, have an IRB that first authorizes and later goes over the research methods so as to secure the rights of human participants.

Intent to Treat: Investigation of clinical trial conclusions that has all information from subjects in the groups to which they were randomized (See Randomization) even if they did not receive the treatment.

Intervention Name: The general term of the exact intervention under trial.

Interventions: Primary interventions under trial: modes of interventions are Drug, Gene Transfer, Vaccine, Behavior, Device, or Procedure.

Investigational New Drug (IND): An untested drug, antibiotic drug, or biological drug that is administered in a clinical trial, which includes any biologically-based item used in vitro for diagnostic uses.

Masked: The understanding of intervention assignment (e.g. Experimental or Control). See Blind

Natural History Study: Study of the natural maturation of a biological entity (such as an animal or a virus) over a time period.

New Drug Application (NDA): An application presented by the maker of a pharmaceutical treatment to the FDA - after the completion of all clinical trials - for a license to commercialize the drug for an assigned condition.

Off-Label Use: A drug prescribed for illnesses besides those authorized by the FDA.

Open-Label Trial: A clinical trial in which physicians and subjects understand the particular drug or vaccine being dispensed.

Orphan Drugs: An FDA category that concerns medicines utilized to care for illnesses and conditions that come about infrequently. The drug companies have minimal financial inducement to create treatments for such conditions. Orphan drug status gives a pharmaceutical firm special monetary inducement to create and offer such treatments.

Peer Review: Critique of a clinical trial by researchers selected by the study sponsor. Such researchers reassess the trials for medical virtue, subject safety, and ethical conditions.

Pharmacokinetics: The methods (in a biological organism) involving intake, dispersal, chemical reaction and voiding of a drug or vaccine.

Phase I Trials: Beginning studies to learn about the metabolism and therapeutic abilities of drugs in humans, the side effects connected with higher doses, and to acquire new proof of usefulness; could include able-bodied subjects and/or patients.

Phase II Trials: Regimented clinical studies carried out to measure the usefulness of the drug for a specific illness or illnesses in subjects with the condition under trial and to find out the typical short-run side effects and hazards.

Phase III Trials: Widened controlled and uncontrolled studies subsequent to early proof indicating usefulness of the drug has been found, and are meant to amass more data to measure the general benefit-risk ratio of the drug and offer a satisfactory foundation for physician labeling.

Phase IV Trials: Studies conducted after a drug is on the market used to outline further data such as the drug's hazards, therapeutic abilities, and best use.

Placebo: A placebo is an inert substance that holds no medicinal value. Observational therapies are frequently compared with the effects of placebos to determine the therapy's usefulness. (See Placebo Controlled Study).

Placebo Controlled Study: A process of the study of drugs in which an inert substance (the placebo) is administered to one group of subjects, while the drug under trial is administered to another group. The outcomes found in the two groups are then compared to learn if the experimental treatment is more useful in dealing with the illness.

Placebo Effect: A physical or emotional shift, happening after a subject receives a substance, that is not the direct effect of any exceptional facet of the substance itself. The shift may be advantageous, a result of the anticipations of the subject and, frequently, the anticipations of the individual distributing the substance.

Preclinical: Relates to the screening of experimental drugs in the laboratory or in animal subjects - the screening that happens prior to when trials in human subjects may be implemented.

Prevention Trials: Relates to trials used to come up with more dependable methods to prevent illness in individuals who have never suffered from the illness or to prevent another bout with an illness from occurring. These means may include drugs, vaccinations, nutritional supplements, or changes in activity level.

Protocol: A plan which forms the basis for all clinical trials. The plan is organized with care to protect the wellness of the subjects as well as to resolve particular research inquiries. A protocol identifies what types of subjects may take part in the trial; the agenda of tests, routines, drugs, and dosages; and the duration of the study. Subjects in a clinical trial must follow a protocol and must be visited on a regular basis by the trial personnel to supervise their health and to check the safety and usefulness of their treatment (See Inclusion/Exclusion Criteria).

Quality of Life Trials (or Supportive Care trials): Relates to trials that search for methods to better the level of comfort and quality of life for persons with a prolonged illness.

Randomization: A process based on probability by which trial subjects are delegated to a treatment group. Randomization lessens the differences between and among groups by evenly spreading individuals with specific features through all the trial arms. The research staff is not made aware of which treatment is more beneficial. Any of the treatments selected may be of help to the subject at the time it is administered (See Arm).

Randomized Trial: A study in which subjects are selected at random to participate in one of two or more treatment arms of a clinical trial. Sometimes placebos are employed. (See Arm and Placebo).

Recruiting: The time period which trial personnel attempt to discover and sign up potential subjects. Recruitment processes can include advertisements and different methods of enticing involvement from possible subjects. (See recruitment status and enrolling).

Recruitment Status: Signals the latest stage of a trial, whether it is planned, ongoing, or completed. Possible values include:
- Not yet recruiting: trial personnel are not yet seeking potential subjects
- Recruiting: trial personnel are recruiting and enrolling potential subjects
- Enrolling by invitation: trial personnel will select potential subjects from a preset population
- Active, not recruiting: study is ongoing (i.e., subjects are receiving treatment or tests), but the enrollment process has closed
- Completed: the study has ended unremarkably; subjects are no longer receiving treatment (the last subject has completed their last visit)
- Suspended: trial personnel have halted their recruiting or enrolling efforts but may resume at a later date
- Terminated: trial personnel have halted their recruiting or enrolling efforts and will not resume; subjects will no longer receive treatment
- Withdrawn: study stopped early, before signing up of first participant
Risk-Benefit Ratio: The risk to particular subjects as compared to the likely benefits. The risk/benefit ratio could vary dependent on the ailment under trial.

Screening Trials: Relates to trials which examine the most effective method to discover particular illnesses or health issues.

Side Effects: Any unwanted processes or outcomes of a drug or treatment. Harmful or adverse effects may include stomachache, diarrhea, skin rash, or other physical ailments. Experimental drugs have to be assessed for both short-term and long-term side effects (See Adverse Reaction).

Single-Blind Study: A study in which one participant, either the researcher or subject, does not know what medication the subject is receiving; also known as a single-masked study. (See Blind and Double-Blind Study).

Standard Treatment: A treatment widely available and sanctioned by the FDA, regarded as effective in the alleviation of a particular illness or condition.

Standards of Care: A therapy routine or medical process based on progressive patient care.

Statistical Significance: The likelihood that an outcome or deviation happened due to random chance. The degree of statistical significance hinges on the number of subjects studied and the data observed, in addition to the size of the deviations detected.

Study Endpoint: A primary or secondary result applied to estimate the usefulness of a treatment.

Study Type: The main fact-finding methods practiced in an experimental protocol; types are Purpose, Duration, Selection, and Timing. Another classification is diagnostic, etiological, and therapeutic.

Surrogate Marker: In reference to a clinical trial, a surrogate marker is defined as a measurement of the effectiveness of a particular therapeutic agent or other treatment as it relates to a specific undesirable endpoint (such as death) that cannot be ethically achieved to demonstrate a cause and effect connection between various elements of a clinical study.

Suspended: See Recruitment Status

Terminated: See Recruitment Status

Toxicity: An adverse effect brought about by a drug that is harmful to the subject's wellness. The degree of toxicity connected with a drug will deviate depending upon the illness which the drug is applied to care for.

Treatment IND: IND stands for Investigational New Drug application, which is a portion of the procedure to acquire licensing from the FDA for selling a new prescription drug in the U.S. This allows for potentially beneficial new drugs to become accessible to urgently sick subjects as early in the clinical process as feasible. Treatment INDs are ready for subjects prior to marketing the drug to the general public, usually during Phase III clinical trial studies. In order to be eligible for a treatment IND, a subject cannot be eligible to participate in the authoritative clinical trial.

Treatment Trials: Relates to trials which examine new therapies, new drug or drug cocktails, or new ideas as to surgery or radiation treatment.

Withdrawn: See Recruitment Status

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