A Systematic Review of Adaptive Seamless Clinical Trials for Late-Phase Oncology Development.

Introduction: Although oncology has seen large scientific and clinical advances over the last decade, it also has one of the lowest success rates for novel agents across therapeutic areas. Adaptive clinical trial design has been a popular option for increasing clinical trial efficiency and the chances of trial success. Seamless clinical trial design are studies in which two or more clinical trial phases are combined into a single study with a pre-specified transition between stages.

Association Between Electronic Diary-Rated Sleep, Mood, Energy, and Stress With Incident Headache in a Community-Based Sample.

Background And Objectives: The aim of this study was to examine the diurnal links between average and changes in average levels of prospectively rated mood, sleep, energy, and stress as predictors of incident headache in a community-based sample.

Methods: This observational study included structured clinical diagnostic assessment of both headache syndromes and mental disorders and electronic diaries that were administered 4 times per day for 2 weeks yielding a total of 4,974 assessments. The chief outcomes were incident morning (am) and later-day (pm) headaches.