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It is known that less than 10% of new molecular entities entering clinical Phase I testing progress beyond the investigational programme and reach the market; this probability is even lower for anticancer agents.
With the establishment of this new standard reference treatment for HRPC, this opened the clinical investigational programme of HRPC for a myriad of phase II and phase III trial options.
27 28 29 However, since all the trials were part of the same investigational programme, it is unlikely that methods of randomisation (remote computer generated lists of random numbers) would be different.
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27 28 29 30 31 32 33 34 One additional six month trial from another investigational drug programme in chronic obstructive pulmonary disease reported preliminary data on mortality with tiotropium mist inhaler 5 µg compared with placebo without additional detail on trial characteristics.
Table 2 summarizes the investigational plan.
The Investigational New Drug (IND) programme, chaired and co-chaired by Drs Elizabeth Eisenhauer and Lesley Seymour, interfaces with the BCSG to carry out phase II trials with a variety of new agents.
Therefore, persistent presence of post-chemotherapeutic CTCs appears to be valuable in the identification of chemotherapy-resistant patients, who could benefit from shifting treatment programme and/or further investigational approaches.
The Compassionate Investigational New Drug program had very few initial participants.
In 1992, overwhelmed with applications, the feds closed the Investigational New Drug program to new members.
And with that, the compassionate Investigational New Drug program was born.
Better selection of patients for studies of future HDCT programmes, as well as other investigational approaches for women with HRBC, may be possible after validation of this and other (Nieto et al, 1999) prognostic models.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com