[David Spillett]

Reply to: Direct to Patient

I’ve reviewed a number of the guidance documents issued by various regulatory authorities in recent weeks and the fundamentals are similar in most instances. The absolute priority is patient safety and all decisions should be made in the best interest of the patient, not necessarily the successful conclusion of your trial. Clearly the regulators allowing this flexibility is positive for all parties, however it also adds an additional layer of inconsistency. What can be justified for one patient / protocol / location might not be justifiable in another circumstance. Any deviation needs to be carefully documented and we should be prepared to justify our actions downstream.