new drug application (NDA)

Ant.: positive study. A study that does not have statistically significant findings, indicating that the intervention being studied probably does not have a beneficial effect. Note: This term can generate confusion because it refers both to statistical significance and the direction of effect (positive or negative). Since studies analyse multiple outcomes simultaneously, the criteria for classifying a study as “negative” are not always clear and, in the case of studies of risk or adverse effects, “negative” studies are ones that do not show a harmful effect.

and • provides information on costs and financial impact. Note 2: The report may optionally discuss organisational considerations. Note 3: A “mini-HTA” may be as rigorous as an HTA report but typically has a restricted scope and so is quicker to produce. Note 4: Related terms include health technology, HTA report, rapid review, level of evidence