The findings suggest that understanding of trial concepts can be improved if explained in clear and local terms.
Trial teams seeking to recruit from South Asian populations should emphasise face-to-face verbal explanation of trial concepts and procedures and consider modified trial literature.
CJH, LS, AJC and DL all contributed to the trial concept and design, interpretation of data and drafting of the manuscript.
YK, DG, AAK, SK, and AT all contributed to the trial concept and design, interpretation of data and drafting of the manuscript.
We describe in this paper the design of the MTOPS trial, the concept of BPH progression, the definition and methods of determining the primary outcome events and the proposed statistical analysis methods.
In early August as the Battle of Pusan Perimeter began, the Eighth United States Army ordered Lieutenant Colonel John H. McGee, the head of its G-3 Operations miscellaneous division, to create a new experimental Army Ranger unit, the Eighth Army Ranger Company, to trial the concept of reestablishing small light infantry companies that specialized in infiltration and irregular warfare.
We offer caution that despite the negative results from the ProCess trial, the concept of early goal-directed therapy should not yet be discounted, but should be revisited once valid clinical measures of microcirculatory and metabolic function are available.
Statisticians traditionally design randomized PoC trials with the concepts of type I and type II error in mind.
Ongoing or not-yet-published neoadjuvant trials integrate modern concepts of treatment like tumor targeting with new biological agents or bisphosphonates.
Therefore it is urgently needed to combine results from current trials with current concepts of tumor-biology in order to understand why therapeutic concepts might fail and to possibly help to design future trials more efficiently.
