Timeline Generation Based on a Two-Stage Event-Time Anchoring Model

The Phase II clinical trials aim to assess the therapeutic efficacy of a new drug. The therapeutic efficacy has been often quantified by response rate such as overall response rate or survival probability in the Phase II setting. However, there is a strong desire to use survival time, which is the gold standard endpoint for the confirmatory Phase III study, when investigators set the primary objective of the Phase II study and test hypotheses based on the median survivals. We propose a method for median event time test to provide the sample size calculation and decision rule of testing. The decision rule is simple and straightforward in that it compares the observed median event time to the identified threshold. Moreover, it is extended to optimal two-stage design for practice, which extends the idea of Simon’s optimal two-stage design for survival endpoint. We investigate the performance of the proposed methods through simulation studies. The proposed methods are applied to redesign a trial based on median event time for trial illustration, and practical strategies are given for application of proposed methods.

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Two-stage self-seeding method for preparation of single crystals of poly(phenylene sulfide)

Proceedings, annual meeting, Electron Microscopy Society of America ◽

10.1017/s0424820100153816 ◽

1989 ◽

Vol 47 ◽

pp. 368-369

Author(s):

Sengshiu Chung ◽

Peggy Cebe

Keyword(s):

Single Crystals ◽

High Performance ◽

Dilute Solution ◽

Two Stage ◽

Annealing Behavior ◽

High Performance Polymers ◽

Seeding Method ◽

Phenylene Sulfide

We are studying the crystallization and annealing behavior of high performance polymers, like poly(p-pheny1ene sulfide) PPS, and poly-(etheretherketone), PEEK. Our purpose is to determine whether PPS, which is similar in many ways to PEEK, undergoes reorganization during annealing. In an effort to address the issue of reorganization, we are studying solution grown single crystals of PPS as model materials.Observation of solution grown PPS crystals has been reported. Even from dilute solution, embrionic spherulites and aggregates were formed. We observe that these morphologies result when solutions containing uncrystallized polymer are cooled. To obtain samples of uniform single crystals, we have used two-stage self seeding and solution replacement techniques.

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