I respectfully disagree. The difficulties companies face enrolling clinical trials today would be immensely greater, IMO, if the Abigail Aliance’s demands became government policy.
Absolutely. Even something as seemingly simple as trying combinations of two unapproved drugs is fraught with regulatory peril. Anyone listening closely to the FDA's doublespeak on this topic at this year's joint NCI/FDA conference on immunotherapy would have picked up on this.
I admire AA's aggressiveness. I wish they had directed it towards Congressional action to alter the accelerated approval process for oncology drugs targeted towards unmet needs. Mandating a relaxed p-value; banning the automatic rejection of subgroup analyses; certifying that endpoints should be evaluated for clinical benefit and never for whether they were considered primary or secondary; and clarifying biostatistical analyses may only be one part of the drug decision process would achieve similar goals without turning the clinical trial process on its head.
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