Glossary of Clinical Research - M

M

• Masked

The knowledge of intervention assignment. (NLM)

• Maximum tolerated dose

The highest dose of a drug or treatment that does not cause unacceptable side effects. The maximum tolerated dose is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found. Also called MTD. (NCI)

• Medication

A legal drug that is used to prevent, treat, or relieve symptoms of a disease or abnormal condition. (NCI)

• Medicine

Refers to the practices and procedures used for the prevention, treatment, or relief of symptoms of a diseases or abnormal conditions. This term may also refer to a legal drug used for the same purpose. (NCI)

• Meta-analysis

The formal evaluation of the quantitative evidence from two or more trials bearing on the same question. This most commonly involves the statistical combination of summary statistics from the various trials, but the term is sometimes also used to refer to the combination of the raw data. (ICH E9)

• Monitoring 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. (ICH E6)

• Monitoring

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), GCP, and the applicable regulatory requirement(s). (ICH E6)

• Multicenter study

• A clinical trial that is carried out at more than one medical institution. (NCI)
• A clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one investigator. (ICH E6 and ICH E9)

• Multidisciplinary opinion

A treatment planning approach in which a number of doctors who are experts in different specialties (disciplines) review and discuss the medical condition and treatment options of a patient. (NCI)

• Multiplicity

A large number or variety. (NCI)