PAREXEL
Topic 1 | Section 4.6.1

Change 21: Confirmation Measurement / Duration of Response

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.