Phase III Trial: Building Flexibility Into Standard Dispensing Rules And Visit Schedule

THE SITUATION: FLEXIBLE PROTOCOL MUDDLES STANDARD DISPENSING RULES

When planning for a global, Phase III trial for treatment intended as add-on therapy to the standard of care for a chronic condition, one sponsor wished to build some flexibility into the visit schedule. The sponsor wanted to allow patients to:

• Continue seeing investigators for follow-up visits after the completion of the drug-dispensing portion of the trial, with investigators recording the visit in IXRS
• Skip any number of treatments if deemed advisable by the investigator, with IXRS keeping track of the visit / dosing schedule upon the patient resuming treatment