H - M of terms

HEALTH TECHNOLOGY ASSESSMENT (HTA): The systematic evaluation of a health technology, such as a drug or device used for treatment, typically including assessment of safety, clinical relevance and cost-effectiveness. The body responsible for HTA in the UK is the National Institute for Health and Care Excellence (NICE). Other examples of HTA bodies include ZIN (Netherlands) and AIFA (Italy).  

HELSINKI AGREEMENT: See DECLARATION OFHEALTH TECHNOLOGY ASSESSMENT (HTA): The systematic evaluation of a health technology, such as a drug or device used for treatment, typically including assessment of safety, clinical relevance and cost-effectiveness. The body responsible for HTA in the UK is the National Institute for Health and Care Excellence (NICE). Other examples of HTA bodies include ZIN (Netherlands) and AIFA (Italy).  
HELSINKI AGREEMENT: See DECLARATION OF HELSINKI
HEPATIC: Relating to the liver. In cancer hepatic disease refers to lesions found in the liver.
HIPAA: The Health Insurance Portability and Accountability Act of 1996 (HIPAA) established national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. It also addresses the security and privacy of health data. All clinical trial data and activities performed by covered entities must comply with HIPAA regulations.
HUMAN SUBJECT: A patient or healthy person participating in a research project.
HYPOTHESIS: A theory, supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation.
IMMUNOTHERAPY (IT): The set of treatments used to harness and enhance the body’s own immune system response to cancer. Usually provided intravenously over a series of infusions, different immunotherapy drugs have different effects to permit the immune system to better detect, infiltrate and ultimately destroy cancer cells. The set of “-mab” drugs, which stands for Monoclonal AntiBody, include such drugs as Ipilimumab, Pembrolizumab and Atezolizumab.  
INFORMED CONSENT: Informed consent is the verification of a personʼs willingness to participate in a research project. Prior to enrollment into a clinical trial, researchers inform participants about all relevant study details. Participants are provided an informed consent document that details all the important study information including its purpose, duration, risks, potential benefits, required procedures, and key contacts, and they will be asked to sign this document if they agree to participate in the trial. The informed consent document is not a contract. Participation in the clinical trial is voluntary and the participant may withdraw from the trial at any time without penalty or loss of benefits to which he/she is otherwise entitled. The research team actively maintains informed consent throughout the trial by providing the participant with any new or developing information.
INFORMED CONSENT DOCUMENT: A 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 will be asked to sign this document if they agree to.
INSTITUTIONAL REVIEW BOARD (IRB): A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that approves and periodically reviews the research in order to protect the rights of human participants.
INTENT TO TREAT: Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized even if they never received the treatment.
INTERVENTION NAME: The generic name of the experimental treatment being studied.
INTERVENTIONS: Primary experimental treatments being studied. Types of treatments may include drug, gene transfer, vaccine, behavior, device, or procedure.
INVESTIGATIONAL NEW DRUG APPLICATION (IND): The petition through which a drug sponsor requests the FDA to allow human testing of a new drug, antibiotic drug, or biological drug in a clinical investigation. This includes an application for a biological product used in vitro for diagnostic purposes. INDs are made available to participants before general marketing begins, typically during Phase 3 studies. To be considered for a treatment IND a participant cannot be eligible to be in the definitive clinical trials.
IN VIVO: Testing or action inside an organism, such as a human subject or patient.
IN VITRO: Testing or action outside an organism (e.g. inside a test tube or culture dish.)
IPILIMUMAB: An IMMUNOTHERAPY drug and monoclonal antibody that works to activate the immune system by targeting CTLA-4, a protein receptor that dampens the effect of the immune system. 
IRIS MELANOMA: Accounting for about 5% of all Uveal Melanomas, this malignancy occurs in the coloured part of the eye, the iris.  
LIVER DIRECTED TREATMENT: Treatment options that pertain to the liver only and seek only to treat hepatic (liver) lesions. These include such treatments as PERCUTANEOUS HEPATIC PERFUSION, SIRT, LIVER RESECTION, TACE and CHEMOEMBOLIZATION. Other directed treatments exist to specifically treat other organs. A SYSTEMIC TREATMENT is used to treat the cancer across the entire body. 
MAGNETIC RESONANCE IMAGING (MRI): A type of scan using a strong magnetic field and radio waves to generate images of parts of the body that can't be seen as well with X-Rays, CT scans or ultrasound. MRI scans are often seen as the Gold Standard of imaging technology with little long term effect on the body. The very latest MRI scanners have such a high resolution that it may soon be possible to undergo scans without the need for contrast agents.
MARKETING AUTHORIZATION APPLICATION (MAA): An application submitted by a sponsor to the EMEA for approval to market a new drug (a new, non-biological molecular entity) for human use in Europe.
MEK INHIBITOR:
META-ANALYSIS: Systematic methods that use statistical techniques for combining results from similar studies to obtain a quantitative estimate of the overall effect of a particular intervention or variable on a defined outcome. This type of analysis is typically hypothesis generating.
MICROWAVE ABLATION (MWA): A type of ABLATION which uses microwaves to burn tumours. A needle, with a microwave source at its tip, enters via the skin to pierce the tumour before the microwave source is activated to burn off the tumour. This procedure is often used to destroy one or two metastatic liver tumours. 
MULTICENTER TRIAL: Clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one investigator.
MULTIPLE-RISING DOSE STUDY: see dose ranging study above. HELSINKI

HEPATIC: Relating to the liver. In cancer hepatic disease refers to lesions found in the liver.

HIPAA: The Health Insurance Portability and Accountability Act of 1996 (HIPAA) established national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. It also addresses the security and privacy of health data. All clinical trial data and activities performed by covered entities must comply with HIPAA regulations.

HUMAN SUBJECT: A patient or healthy person participating in a research project.

HYPOTHESIS: A theory, supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation.

IMMUNOTHERAPY (IT): The set of treatments used to harness and enhance the body’s own immune system response to cancer. Usually provided intravenously over a series of infusions, different immunotherapy drugs have different effects to permit the immune system to better detect, infiltrate and ultimately destroy cancer cells. The set of “-mab” drugs, which stands for Monoclonal AntiBody, include such drugs as Ipilimumab, Pembrolizumab and Atezolizumab.  

INFORMED CONSENT: Informed consent is the verification of a personʼs willingness to participate in a research project. Prior to enrollment into a clinical trial, researchers inform participants about all relevant study details. Participants are provided an informed consent document that details all the important study information including its purpose, duration, risks, potential benefits, required procedures, and key contacts, and they will be asked to sign this document if they agree to participate in the trial. The informed consent document is not a contract. Participation in the clinical trial is voluntary and the participant may withdraw from the trial at any time without penalty or loss of benefits to which he/she is otherwise entitled. The research team actively maintains informed consent throughout the trial by providing the participant with any new or developing information.

INFORMED CONSENT DOCUMENT: A 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 will be asked to sign this document if they agree to.

INSTITUTIONAL REVIEW BOARD (IRB): A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that approves and periodically reviews the research in order to protect the rights of human participants.

INTENT TO TREAT: Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized even if they never received the treatment.

INTERVENTION NAME: The generic name of the experimental treatment being studied.

INTERVENTIONS: Primary experimental treatments being studied. Types of treatments may include drug, gene transfer, vaccine, behavior, device, or procedure.

INVESTIGATIONAL NEW DRUG APPLICATION (IND): The petition through which a drug sponsor requests the FDA to allow human testing of a new drug, antibiotic drug, or biological drug in a clinical investigation. This includes an application for a biological product used in vitro for diagnostic purposes. INDs are made available to participants before general marketing begins, typically during Phase 3 studies. To be considered for a treatment IND a participant cannot be eligible to be in the definitive clinical trials.

IN VIVO: Testing or action inside an organism, such as a human subject or patient.

IN VITRO: Testing or action outside an organism (e.g. inside a test tube or culture dish.)

IPILIMUMAB: An IMMUNOTHERAPY drug and monoclonal antibody that works to activate the immune system by targeting CTLA-4, a protein receptor that dampens the effect of the immune system.

IRIS MELANOMA: Accounting for about 5% of all Uveal Melanomas, this malignancy occurs in the coloured part of the eye, the iris.  

LIVER DIRECTED TREATMENT: Treatment options that pertain to the liver only and seek only to treat hepatic (liver) lesions. These include such treatments as PERCUTANEOUS HEPATIC PERFUSION, SIRT, LIVER RESECTION, TACE and CHEMOEMBOLIZATION. Other directed treatments exist to specifically treat other organs. A SYSTEMIC TREATMENT is used to treat the cancer across the entire body.

MAGNETIC RESONANCE IMAGING (MRI): A type of scan using a strong magnetic field and radio waves to generate images of parts of the body that can't be seen as well with X-Rays, CT scans or ultrasound. MRI scans are often seen as the Gold Standard of imaging technology with little long term effect on the body. The very latest MRI scanners have such a high resolution that it may soon be possible to undergo scans without the need for contrast agents.

MARKETING AUTHORIZATION APPLICATION (MAA): An application submitted by a sponsor to the EMEA for approval to market a new drug (a new, non-biological molecular entity) for human use in Europe.

MEK INHIBITOR:

META-ANALYSIS: Systematic methods that use statistical techniques for combining results from similar studies to obtain a quantitative estimate of the overall effect of a particular intervention or variable on a defined outcome. This type of analysis is typically hypothesis generating.

MICROWAVE ABLATION (MWA): A type of ABLATION which uses microwaves to burn tumours. A needle, with a microwave source at its tip, enters via the skin to pierce the tumour before the microwave source is activated to burn off the tumour. This procedure is often used to destroy one or two metastatic liver tumours.

MULTICENTER TRIAL: Clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one investigator.

MULTIPLE-RISING DOSE STUDY: see dose ranging study above.