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Study accrual is on target, with 261 out of a planned 300 metastatic tumor biopsies performed by August 2016.
To answer pressing clinical questions, innovative trial designs are needed, along with operational strategies that include risk factor enrichment, target-based end point selection and validation, flexible study accrual and monitoring, and techniques that permit early termination when initial treatment outcomes are poor.
Interventions of all categories had no negative impact on participant satisfaction or study accrual.
The flow chart of the literature search strategy and study accrual and disposition is detailed in Figure 1.
There is little to no indication that the interventions tested in these trials negatively impact participant satisfaction or study accrual.
While a total of 788 patients are needed for this study, accrual as of July 2011 is 367 (47%).
Similar(35)
If multiple procedures were to be considered, patients may be unwilling to relegate the choice of procedure to a randomized process, and this could represent a significant impediment to subject accrual and study feasibility or generalization of findings.
This study completed accrual in 2010 and is expected to be completed in March 2011.
The study projects accrual over 48 months with 12 months of additional follow-up.
It was decided by the sponsor to close the study to accrual prematurely on 31 December 2010.
Eighty women with a median age of 57 years were included in the study (86%% accrual rate).
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