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10.1002/pst.2132

http://scihub22266oqcxt.onion/10.1002/pst.2132
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34002467!9290610!34002467
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suck abstract from ncbi


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pmid34002467      Pharm+Stat 2021 ; 20 (6): 1168-1182
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  • Selection bias, investment decisions and treatment effect distributions #MMPMID34002467
  • Wiklund SJ; Burman CF
  • Pharm Stat 2021[Nov]; 20 (6): 1168-1182 PMID34002467show ga
  • When making decisions regarding the investment and design for a Phase 3 programme in the development of a new drug, the results from preceding Phase 2 trials are an important source of information. However, only projects in which the Phase 2 results show promising treatment effects will typically be considered for a Phase 3 investment decision. This implies that, for those projects where Phase 3 is pursued, the underlying Phase 2 estimates are subject to selection bias. We will in this article investigate the nature of this selection bias based on a selection of distributions for the treatment effect. We illustrate some properties of Bayesian estimates, providing shrinkage of the Phase 2 estimate to counteract the selection bias. We further give some empirical guidance regarding the choice of prior distribution and comment on the consequences for decision-making in investment and planning for Phase 3 programmes.
  • |*Bayes Theorem[MESH]
  • |Bias[MESH]
  • |Humans[MESH]


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