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Progression-free survival (PFS) is increasingly used as a primary endpoint in oncology clinical trials. However, trial conduct is often such that PFS data on some patients may be partially missing either due to incomplete follow-up for progression, or due to data that may be collected but confounded by patients stopping randomized therapy or starting alternative therapy prior to progression. Regulatory guidance on how to handle these patients in the analysis and whether to censor these patients differs between agencies. We present results of a reanalysis of 28 Phase III trials from 12 companies or institutions performed by the Pharmaceutical Research and Manufacturers Association-sponsored PFS Expert Team. We show that analyses not adhering to the intention-to-treat principle tend to give hazard ratio estimates further from unity and describe several factors associated with this shift. We present illustrative simulations to support these findings and provide recommendations for the analysis of PFS. [ABSTRACT FROM PUBLISHER] more...

The evaluation of environmental enrichment techniques for nonhuman primates over long periods of time has had mixed results. Some studies report rapid habituation to new enrichment items, while others note continued use. We have investigated the use of three different enrichments that had been available to paired and singly caged chimpanzees for several years. Twenty subjects were observed during 200 hr of scan sampling while singly caged and while pair housed. Each subject had a variety of enrichments available and their use of a television, ball, and mirror were recorded. The chimpanzees had previous exposure to all of the items: televisions had been available for a mean of 22.75 months, balls had been available for 55.9 months, and mirrors had been available for 25.9 months. The results indicated that the chimpanzees continued to use the enrichments for small amounts of time (0.27%–1.53% of the observations) even after such prolonged exposure. Television and ball use were significantly higher than mirror use. Housing condition was not a significant factor in the analyses, contrary to expectations. We concluded that several simple enrichment items may be effective in offering variety and choices to the nonhuman primate and can be one element in a comprehensive environmental enhancement plan. [ABSTRACT FROM AUTHOR] more...

Explores the contributions of affect theory in their applications to the understanding of post-traumatic stress disorder (PTSD). Why shame is often neglected as an issue in treatment; Shame and affect theory; Affect theory and PTSD. more...

Discusses that Asconius' naming of either Caesar or Crassus as the person Cicero was referring to in his speech near the beginning of `In Toga Candida,' reveals his lack of authoritative evidence. Subject of the speech; Asconius' reasons for identifying the nobles; Motives and resources of another noble P. Cornelius Sulla. more...