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Does anybody have experience using “Best Available Therapy (BAT)” as a comparator arm in your clinical study, and if so:
1) Did the BAT’s have to be listed in the protocol and/or CTA submission
2) In Europe were the BAT’s classed as IMP’s or Non-IMP’s
2a) If IMP’s did you have to purchase and label them for study? Please provide details.
2b) If Non-IMP’s did your company procure and supply or did the Clinical Sites supply (reimbursed by your company OR covered under patient’s insurance)?
Thanks in advance!