NRG-BR007: A phase III trial evaluating de-escalation of breast radiation (DEBRA) following breast-conserving surgery of stage 1, HR+, HER2-, RS ≤18 breast cancer. This is an ASCO Meeting Abstract ...
The US Food and Drug Administration (FDA) this week issued new draft guidance on study design and analysis for non-interventional studies being included as part of a regulatory submission. The draft ...
The European Medicines Agency (EMA) has adopted a reflection paper on the design and conduct of non-interventional studies (NIS) that generate real-world data (RWD) for regulatory purposes. These ...
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