Chief...
<When embarking on trials, wouldn't one expect the company to ensure that the trials will satisfy the "minimum pre-requisites of the HC", at the least?>
This is why there is a phase I (toxicity/preliminary dose finding), phase II (dose finding/efficacy), and phase III (efficacy-placebo controlled and comparative) trial.
<Would a company embark on extensive and expensive trials without ensuring that the data they collected conformed to the approving agencies?>
It's not really a matter of conforming...it's not a secret as to the information required...what it very often boils down to is what the company has provided as opposed to what the agency wants. Sometimes, the company will provide overwhelming data supporting the efficacy of the drug. As a result, it may take just one trial with sufficient population numbers (or accruals, as the term is referred to as). This occurred in the CAPRIE trial that resulted in the release of a drug called clopidogrel (Plavix). They had around 17,000 patients in a huge multi-centre trial. This one trial, added to phase I/II trials was enough to prompt release of the drug. Other times, a company may opt for two or more smaller trials.
<Would they not pre-consult with the approving authority as to the type of material they "absolutely require" at a minimum to satisfy the pre-screening for approval?>
Again, the agency just wants to see clean data that shows the drug is efficacious and doesn't have overly serious adverse effects. The company knows this, but also wants to perform the minimum that it has to (obviously, in order to save money). There normally is no pre-consultation, unless the condition being treated is of such magnitude that the drug needs to come onto the market because there is no other available treatment measure eg. HIV.
<Would not the same company, then ensure that as a minimum they would exceed those minimum requirements to ensure no screw-ups?>
One would think...
Regards,
Jeff
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