Justification www.selleckchem.com/products/carfilzomib-pr-171.html for placebo Thirty out of 34 responses were in favor of the use of placebo, two were against the use of placebo and two did not opine. The use of placebo was justified, subject to the condition that: a) the said disease had no defined/established standard of care; b) adequate rescue procedures for patient withdrawal and safety management were ensured; c) back-up investigators present at the site for additional oversight; and d) additional monitoring ensured by the sponsor/CRO. It was also opined that the EC should review the scientific soundness of the placebo-controlled trial in greater depth and have an increased level of subject education at screening stage.

Other miscellaneous opinions suggested that standard treatment must also be provided along with the placebo since putting the patient only on placebo would be unethical; also, wherever possible, patient should be in-patient so that emergency medical care could be made available; and placebo should be used only for proof of concept trials. Post-trial access to investigational drug Out of 34 responders, 21 were in favor and 13 were against the investigational drug being made available to patients post end of trial. The responders who answered ??Yes?? expressed the following: a) on humanitarian grounds only in case of terminal illness; b) if the investigational drug is found to be beneficial and not going to be marketed in India; c) patients may benefit and get used to the drug wherein it would be difficult for the investigator to withdraw the drug post trial completion; Dacomitinib and d) trial subjects may not afford the commercial drug and it could be given at no cost to reciprocate their contribution to science.

The responders who answered ??No?? for the drug being made available, presented the following justification: a) drug may not have adequate safety/stability and additional further studies post end of study could change the efficacy/safety information to preclude such treatment; b) the drug is not known to be reacting in uncontrolled http://www.selleckchem.com/products/Gemcitabine-Hydrochloride(Gemzar).html conditions post study without adequate oversight and more importantly, if there was any adverse event/death during the window period of trial conclusion and marketing authorization, the investigator would be charged of using an unapproved drug; and c) it could also happen that some trial subjects could be benefitted from the drug during the trial and may insist on continued use post trial, but the regulatory authority could end up to refuse marketing approval for the drug. Vulnerability of low literacy patients Out of 34, 26 responders felt that Indian patients were vulnerable and 8 responders felt otherwise.