Glossary

A t-test is a statistical test that helps compare whether the average values of two groups of data are significantly different from each other. It is used to obtain a measure of the difference between the means (averages) of the groups, relative to the spread of data within each group.

The t-test helps decide whether a difference in mean values between two groups is due to random chance in a sample selection.

Refers to the patients the medicine is intended for.

A target product profile is a document that describes the features of a product (such as a medicine) that a company is planning or developing. The document can include a wide range of information such as dosage, how the product will be administered (for example this could be a patient taking a medicine by mouth, or a hospital nurse giving the medicine as an injection), formulation, clinical studies, adverse reactions (unwanted harmful effects) and contraindications (situations when the product should not be used).

The target product profile is written by the company developing the treatment, and if it is begun early it can help keep their development work properly focused on the end goal. A target product profile can also be used as a basis for discussions between the company and those regulatory authorities that will assess the product for release to market.

These are medicines designed in a manner that focuses the activity of the medication in certain parts of the body. The goal of a targeted medicine is to increase the length of time that the medicine interacts with the diseased tissue in a specific area of the body and spares other parts (e.g. affecting tumour cells rather than adjacent healthy cells). The advantages of a targeted release system are the reduction in the frequency of the dosages taken by the patient, having a more consistent effect of the medicine, reduction of side effects, and reduced fluctuation in medicine levels in the body.

Finnish National Institute for Health and Welfare. https://www.thl.fi"

Thalidomide is a medicine that was developed in the 1950s as a sedative. It was used later against nausea in pregnant women, but this resulted in the birth of about 10,000 infants with deformed limbs, and sometimes with other serious problems such as blindness, deafness, and heart problems. More than half of these children died. This crisis led to more structured regulations for the development and use of medicines. Currently, thalidomide is used to treat certain cancers, and to alleviate symptoms of leprosy.

Therapeutic alternatives are medicines that are chemically different from the one prescribed (used) but which have the same clinical effect. Therapeutic alternatives are not to be confused with generics.

Therapeutic indications are a description of the disease to be treated with a medicine, and the population for which the medicine is intended. They include the specifics about the disease, and restrictions to the patient population such as age, and whether the medicine is intended for symptom relief, cure or prevention, or whether it is for diagnostic use only.

Example statements from therapeutic indications:

• Symptomatic treatment of mild to moderately severe Alzheimer™s disease.
  
• Active substance X 40 mg is indicated for the prevention of post-operative nausea and vomiting (PONV) in adults.
  

Therapeutic indications must be clearly and concisely stated within the summary of product characteristics (SmPC) document that each medicine requires in the EU.

Therapeutic vaccines introduce antigens associated with an illness to teach the body to fight against a different illness.

A time-to-event endpoint is the time taken until a pre-defined event takes place, once groups in a trial start to receive treatment or placebo. There are several kinds of time-to-event endpoints. For example, time-to-progression (TTP) is the time between randomisation of people to groups within a trial, and disease progression. Disease progression in this case must be defined, and it must be specific and measurable. For example, the growth of a particular tumour type by a minimum amount may be used as an indicator of disease progression.