What metrics are typically used to determine if the drug is successful?

The ultimate success of a new drug or drug combination is judged by the “safe and effective” standard.  Both of course are examined in context.  Safe often means safe enough – or no less safe than what we have today.  Some cancer treatment have severe side effects – but because their benefits are judged acceptable – they are approved.  Effective means that cancer patients benefit in a meaningful way.  This often involves living longer.  When survival is not impacted, meaningful quality of life improvements are required.  In some situations, cure rates are the measure of success.  Survival benefit, which is the most common measure of success, can take a year to several years to determine.

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(c) 2012 Tom Beer and Larry Axmaker