Glossary

Belgian National Competent Authority. http://www.fagg-afmps.be/"

Belgian Health Care Knowledge Centre. https://kce.fgov.be"

USA National Competent Authority. http://www.fda.gov/"

A formulation is a mixture of different chemical substances prepared according to a specific method to create a medicinal product.

Fraud is an intentional act of deception. An example of fraud within a research setting might be a deliberate attempt to fabricate data or present data in a misleading way. Fraud does not include honest errors or poor research processes, unless it is done with an intention to deceive. In research, fraud can impact the sponsor financially, have severe consequences for a study™s credibility, and could even lead to patients accessing ineffective or harmful treatments.

Freeze-drying, also known as lyophilisation, is used to preserve a perishable material or make the material in a medicine more convenient for transport. It works by freezing the material and then allowing the frozen water in the material to change directly from the solid to the gas phase without passing through the intermediate liquid phase.

Functional Observational Battery

Futility is the inability of a clinical trial to achieve its objectives.

Problems such as difficulty recruiting enough patients can mean that a trial will not give a result that can be properly statistically analysed. If such problems are discovered during the trial, it may be appropriate to stop the trial early. This kind of calculation is known as a futility assessment, and is one kind of interim analysis.

Stopping a trial early because it is unlikely to achieve a statistically reliable result is ethically appropriate because it prevents exposure of patients unnecessarily to treatments or other interventions. It can also save time and therefore costs.