within that specific context fulfils the requirements of the subsequent sections of this document. Example: The evidence base surrounding a modulating effect of Factor X on levels of calcium demonstrate a consistent increase in bone density but all studies have been conducted in postmenopausal women. The indication would need to include a contextual qualifier such as in postmenopausal women’. ‘Used Determining which studies to include for further analysis It is important that only studies that are relevant to proposed listable indications are included in any subsequent analysis. The following table provides guidance regarding the inclusion and exclusion of studies from further analysis based on relevance to a proposed listable indication. Excellent Good Satisfactory Unsatisfactory Relevance Identical active Identical active Identical route Different to ingredient, ingredient and of active medicine dosing details, route of administration ingredient or formulation administration, Comparable trial of and route of Comparable active administration. administration. dosing details ingredient, or and formulation formulation. and dosing details. Relevance Population Population Some Major to target studied is studied is differences differences or population identical to the comparable to between study differences of target the target and target uncertain population. population. populations clinical but significance ‘clinically reasonable’ to exist between extrapolate study and evidence to target the target populations. population. Relevance Study directly Study directly Study directly Study does not to health measures measures measures directly health benefit health benefit health benefit measure benefit in listable in listable in listable health benefit indication as indication as indication as in listable primary secondary post-hoc indication. outcome. outcome. analysis.
within that specific context fulfils the requirements of the subsequent sections of this document. Example: The evidence base surrounding a modulating effect of Factor X on levels of calcium demonstrate a consistent increase in bone density but all studies have been conducted in postmenopausal women. The indication would need to include a contextual qualifier such as ‘Used in postmenopausal women’. Determining which studies to include for further analysis It is important that only studies that are relevant to proposed listable indications are included in any subsequent analysis. The following table provides guidance regarding the inclusion and exclusion of studies from further analysis based on relevance to a proposed listable indication. Excellent Good Satisfactory Unsatisfactory Relevance to medicine Identical active ingredient, dosing details, formulation and route of administration. Identical active ingredient and route of administration, Comparable dosing details and formulation. Identical route of administration Comparable active ingredient, or formulation and dosing details. Different active ingredient or of administration. Relevance to target population Population studied is identical to the target population. Population studied is comparable to the target population. Some differences between study and target populations but ‘clinically reasonable’ to extrapolate evidence to the target population. Major differences or differences of uncertain clinical significance exist between study and target populations. Relevance to health benefit Study directly measures health benefit in listable indication as primary outcome. Study directly measures health benefit in listable indication as secondary outcome. Study directly measures health benefit in listable indication as post-hoc analysis. Study does not directly measure health benefit in listable indication. trial
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