A pharmaceutical company is conducting a clinical trial in Turkey and a Phase II trial is ongoing. In the middle of the trial, the company applied to the Ethical committee and declared that they would not continue the Phase II trial but would go on as Phase III. Both the EC and MoH rejected this appeal. Your thoughts?
You should not allow the company to proceed into phase III. Phase II in clinical trial is important to evaluate how well the drugs work. How come you are not sure with the efficacy and then want to proceed into the next steps? Doing this means you play the volunteers (usually 200 - 300 people in a group) into a vulnerable condition.
Phase II study should be completed. Cession the phase II study would creat a chaotic atmosphere for every Ethic Committee
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