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In general, only valid surrogate outcomes are accepted (Section 4.5.4 Suppl. G-BA VerfO).
Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians.
Surrogate outcomes are generally not favoured and are considered less relevant for the final decision than clinical outcomes.
Surrogate outcomes that have not been fully evaluated may be used based on the concept of surrogate threshold effects [25].
Surrogate outcomes that had a direct link to decreasing the incidence of aspiration pneu- monia were considered.
All the trials were actually focussed on ancillary or surrogate outcomes.
Surrogate outcomes may not be associated with the primary outcome.
Of the 68 surrogate outcomes, 28 were explicitly defined as 'not accepted' (41% of the surrogate outcomes).
Prentice developed a statistical criterion for evaluating surrogate outcomes in trials, 24 which requires that surrogate outcomes fully capture the treatment effect on patient-centred outcomes.
The concern is that any systematic lack of preference for surrogate outcomes could lead to high barriers to access for the therapeutic areas that rely on surrogate outcomes.
Another statistical approach to validate surrogate outcomes is using data from multiple RCTs that assess surrogate outcomes and patient-centred outcomes.
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