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Keywords: Assurance, bayes, go, no go, Lalonde
In the seminal paper, “Model Based Drug Development”, by Lalonde et. al. , the idea that was introduced to utilize a dual criteria progression decision rule that would consider sufficient evidence of the existence of a treatment effect, described as the “dignity” line for developing a compound, as well as if that effect may be commercially viable. This method also includes a possible Pause result, taken when there is a sufficient chance of commercial success but an insufficient chance of reaching the dignity line. We will consider Bayesian, Frequentist, as well as through Assurance/POS based methodologies for implementation of this method. We will examine the impact of clinical development planning on facilitating correct decision making. We also examine opportunities for the inclusion of additional information, such as from PK/PD modeling or from publications.