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"Right now, one of the biggest areas of failure is in phase II trials, when you get to those places where you're looking for efficacy and you suddenly discover that the compound that worked great in your animal model doesn't do much in humans," he says.
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Once the company finds the best dose, it plans to give its drug to just 15 to 30 patients and look for efficacy.
Regarding this last point, while many efforts have been carried out looking for increased efficacy of antitumoural agents, the use of NPs to avoid side effects allowing for extended therapy has been also demonstrated (Comenge et al. 2012).
A phase II study looking for therapeutic efficacy of foetal neural grafts to the brain of patients with Huntington's disease ("MIG-HD", ref. NCT00190450) is currently ongoing in Europe, following the promising results of a pilot study [2], [3], [4].
"We have to perform large randomized trials first to look for clinical efficacy and then to look for cost efficacy.
Phase I/II studies combining docetaxel with cisplatin and/or 5-FU were undertaken in recurrent or metastatic SCCHN patients to look for improved efficacy and safety.
The data from these patients were reviewed by an independent malaria expert and a neuropediatrician to confirm or reassess the initially planned sample size of 600 patients, and to look for insufficient efficacy and potential safety issues.
If they have the answer we were looking for, this reinforces the efficacy of our strategy; if they don't, we tend to simply assume that we asked the wrong person.
But he told me Alkahest will also be "looking for any biomarkers or any hints of efficacy".
We are continually looking for ways to improve curation efficiency and efficacy.
Scangos says companies should start looking for genetic variations that predict a drug's efficacy in the very early stages of clinical testing.
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