At END of Study – can the patient continue getting investigational drug –if it is beneficial to patient?
CHP: Probably not. Reason for this qualifier (probably) is that no drug can be given to any patient unless that drug has been approved by the regulatory authorities of the country in question. IN some cases and for some serious conditions, the regulatory authorities might approve a “compassionate use” provision and make available to new drug. That said, what if the trial is a ‘placebo controlled’ trial and the patient who was ‘helped’ was on the placebo.