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Ontario Public Drug Programs

Glossary – S

This glossary provides brief explanations of terms used in the Ontario Public Drug Programs web pages. To access a term definition, select the appropriate letter from the alphabet below.

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
SAP

See Special Access Program

Second review

A manufacturer has six weeks from the date the first recommendation letter is issued to respond to the CED's concerns or questions, while maintaining the submission's existing review ranking.

If the manufacturer fails to meet the deadline, then the product loses its ranking and will be reviewed a second time only as the CED agenda permits.

Side effects

Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects. See Adverse Reaction.

Single-arm study

A study in which all participants are given the same drug (i.e., there is no control group that is given an alternative drug or a placebo). The lack of a control group limits the interpretability of data because comparisons cannot be made between the effects of the study treatment and those of an alternative treatment or a placebo.

Single-blind study

A study in which one party, either the investigator or the participant, is unaware of what medication the participant is taking.

Blinding is used together with randomization. Single-blinding means the participant doesn't know whether he or she is receiving the experimental product, an established treatment for that disease, or a placebo. The research team, however, does know what the participant is receiving.

Blinding is done to make sure factors such as investigators' preferences or expectations, or participants' desire to please investigators or hopes of improvement, cannot influence and distort results. See Double-blind.

Single-source drugs

Drugs containing a unique chemical, strength, dosage form and route of administration, sold by one manufacturer.  Once a generic drug comes onto the market, these drugs become referred to as “brand name” drugs.

In Ontario, to be considered for listing in the Formulary, a single-source drug  (often referred to as “brand product” or “original product”), must meet the requirements of Ontario. Reg. 201/96 under the Ontario Drug Benefit Act.

Special Access Program (SAP)

Patients can only access drugs that have not been approved for sale in Canada and have not received a Notice of Compliance through Health Canada’s Special Access Program.  The program acts as a broker between the manufacturer and the physician; it is not a funding mechanism.  If access is approved through the SAP, it is up to the manufacturer to supply the medication and to decide whether to sell it or to provide it free of charge.

Standard treatment

A treatment currently in wide use, approved as safe and effective in the treatment of a specific disease or condition.

Statistical significance

The probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends upon the number of participants studied and the observations made, as well as the magnitude of differences observed.

Statistically significant

Means that the findings of a study are unlikely to have arisen by chance. Significance at the commonly cited 5% level (P < 0.05) means that the observed difference or greater difference would occur by chance in only 1 of 20 similar cases.

Surrogate marker

An indirect measurement or indication of the way a disease is progressing, or of a drug’s effectiveness. A surrogate marker can predict a patient’s clinical outcome without relying on traditional clinical endpoints, such as death or the development of a major infection. For example, the T-cell count of an HIV patient is a surrogate marker.

Synthesis of evidence

A generic term to describe methods used to summarize (compare and contrast) evidence in order to answer a defined clinical question. This can include systematic review (with or without meta-analysis), and qualitative and narrative summaries.

Systematic review

A systematic review is a literature review using explicit methods, focused on a single question that tries to identify, appraise, select and synthesize all high quality research evidence relevant to that question, and to combine valid studies. Systematic reviews are generally regarded as the highest level of medical evidence.

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