Could part of what we consider delays be due to recruiting. If the number of participants is not recruited timely then it takes longer for a phase to complete.
Phase II CERE-120 recruited in a few short months...opened in April 2007, last surgery in September 2007...also Ceregene placed strict and quick time frames on the time between initial interview/qualifying, informed consent and surgery. Interview HAD TO be followed by Informed Consent within two weeks. Surgery HAD TO be done within two weeks of Informed Consent. This is not the usual process...right? |
recruiting
Ceregene is without a doubt trying to give the pd community what it needs as quickly as possible. Clinicians often can't fill their trials, [not ceregene] - recruitment is a big problem.
I don't like pointing this out, but most drugs don't make it [being proven in my ten years of advocacy]. This doesn't help to recruit anyone. Latest to be non-approved - KW-6002 - istradefylline. People have been on that for years. Hopefully, they will go forward with it, but sometimes a person just can't be measured by paper stats. Take the drug away tho and then they can tell how efficacious it was....too late of course. paula |
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