RECIST 1.0:

• Confirmation of CR and PR required irrespective of study endpoints

RECIST 1.1:

• Response is primary endpoint: confirmation is required.
  • e.g. phase II single agent trial (non-randomized)
• Response is secondary endpoint: confirmation is not required.
  • e.g. randomized trial with stable disease or progression endpoints (e.g., PFS)
  • However, elimination of the requirement for response confirmation may increase the importance of central review to protect against bias, in particular in studies which are not blinded.