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Over the years, the essential process of content validation has been included as a central topic in various PRO guidance documents authored by PRO outcomes working groups and drug regulatory agencies [ 16- 27].
As demonstrated by the SmPC language for both cabazitaxel and radium Ra 223 dichloride, the EMA provided more comprehensive coverage of both the positive and negative PRO outcomes from the registration studies for these products, whereas negative PRO outcomes were discussed within the DAP but did not translate into label language in the US.
Although for certain therapeutic areas (most notably, psychiatric disorders) PROs may be included in clinical trials as primary efficacy indicators, commercial use of PRO outcomes focuses predominantly on their employment as secondary endpoints designed to provide 'added value' data to support key biomedical endpoints.
This led to conjecture that a lack of sustained improvements from Week 8 to Month 12 may be observed for some PRO outcomes due to the presence of patients who did not sustain remission at Month 12.
To test this hypothesis, we conducted a post hoc exploratory analysis examining whether changes in PRO outcomes from Week 8 to Month 12 differed between patients who sustained remission at Month 12 and patients who were not in remission at Month 12.
Thus, our study identified specific patient populations who demonstrate worsening PRO outcomes post-TKA.
Similar(42)
Consistent and sustained policy interventions are needed to provide appropriate signals for pro-poor, pro-growth outcomes to trade.
There is a reason the Nevada Gaming Control Board would never allow betting on pro wrestling: outcomes are predetermined.
However, the terms PRO and outcome are ambiguous, rendering it difficult to determine PRO constructs.
Perhaps businesses are just giving to candidates who already are likelier to support pro-business outcomes.
These effects can sometimes nullify, or even reverse, the assumed relationship between minority-protective judicial review and pro-minority outcomes.
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