Autor: |
Sax, Frederic L., Curran, Marla, Athey, Sarah, Schnorr, Christoph, Gouldstone, Martin |
Předmět: |
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Zdroj: |
Applied Clinical Trials; Apr/May2016, Vol. 25 Issue 4/5, p26-34, 9p |
Abstrakt: |
The article discusses the integration of evidence-based planning and real-world evidence (RWE) through the proposed three-pillar approach for achieving development productivity. The proposed three-pillar approach includes the question-based process which identifies what success looks like for the patient wherein the robust target product profile (TPP) is the answer, the integrated evidence plan (IEP) is designed for pillar second and scenario development and trade-off analysis in Pillar three. |
Databáze: |
Complementary Index |
Externí odkaz: |
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