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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.
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Sweden is even trialling the concept of a six-hour work day.
A Fellow who worked in South Africa described how her fellowship helped her appreciate how cultural values influence clinical trials: The concept of informed consent is that the patient can withdraw at any time.
Three of the seven practices indicated that they were trialling the concept of a GP supervisor who consults none of their own patients (or very limited number) throughout a session while they undertake responsibility for supervising all the learners in the practice.
Gefitinib and lapatinib are now in clinical trials to test the concept that simultaneous treatment with growth factor inhibitors combined with ER-targeted therapy is more effective than either treatment by itself.
The ongoing Treat CTC trial is the first international, liquid biopsy-based trial evaluating the concept of targeting chemoresistant minimal residual disease: detection of CTCs following adjuvant chemotherapy (adjuvant cohort) or neoadjuvant chemotherapy in patients who did not achieve pathological complete response (neoadjuvant cohort).
Although phase III trials in EOC are not available, in triple negative breast cancer, a negative phase III trial opened the concept of a better understanding of mechanisms supporting PARP resistance and a better definition of clinical setting for PARP inhibitors development [ 83].
In the IMPACT trial the changes in the proliferation marker Ki67 were predictive of outcome in the large ATAC adjuvant trial, supporting the concept of using the neoadjuvant scenario to assess new therapeutic agents/ideas prior to initiating large phase 3 studies.
The Dutch FA was keen to give a trial to the concept in Cup matches but Fifa said the decision should be put off for the time being.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com