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In the United States, only a narrowly tailored government interest of the highest order can justify even the partial closure of a trial.
Other reasons for withdrawal included the closure of a trial site and various circumstantial events unrelated to the trial medications.
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"It must be seen for what it is: the closure of a single trial in a field that has generated exciting results in the past," he says.
The analysis of the 130 seminoma patients randomised until closure of the trial revealed a nonsignificant 10% difference in progression-free and a nonsignificant 5% difference in overall survival in favour of the combination of cisplatin/etoposide (Horwich et al, 2000).
While prior retrospective studies of combination rituximab and temozolomide demonstrated promising results of ORR of 53-100 % and 1-year OS of 55 %, a multicenter phase II trial failed to reproduce the results with early closure of the trial for a poor response rate of 14%% and median PFS of 7 weeks [ 67– 67].
There is growing concern that a trial closure of a junction on the M4 at Port Talbot could harm the local economy.
Our research was conducted against the backdrop of the premature closure of a Phase III clinical trial of antiretroviral pre-exposure prophylaxis among female sex workers in Douala [ 24].
For reasons of clarity, the data shown combine all events recorded in each arm until the trial closure of the trial (September 2005), including also those occurring in arm A after the shift to a 3-weekly schedule in that arm in March 2005.
Four hundred forty-eight patients were randomized in the ATENA trial from January 2001 until premature closure of the trial on November 2005 due to poor recruitment, as a result of the publication of the MA.17 trial results.
With the premature closure of the trial, however, the trial was clearly underpowered to establish a causal relation between the intervention and the outcomes, and the results cannot be generalised.
Premature closure of the trial greatly curtailed the power of the study to detect an effect on HIV (23 events provided only ∼40% power to detect a 50% reduction in risk).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com