For conducting phase III trial on safety & efficacy of Poly herbal formulation, can we enroll >3-12 years of child?
CHP: The answer would depend, in my view, on the safety data from the Phase I, IIa, IIb studies along with the Investigators Brochure (IB) information. Certainly, if the agent is intended for children some would say that it is unethical to not include this age range in studies. The problem is in the control of the dosages of your theoretical “Poly herbal formulation”. Also to be considered is the data you would be collecting. It is one thing to ask an adult for samples of blood but another for a child.
