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ESMO-MCBS Evaluation Forms Version 1.0

There are four evaluation forms, which can be downloaded below:

Evaluation form 1 - For new approaches to adjuvant therapy or new potentially curative therapies

Hyper mature data from studies that were un-blinded after compelling early results with subsequent access to the superior arm are contaminated, subsequently late intention to treat (ITT) follow-up data are not evaluable

Evaluation form 2a - For therapies that are not likely to be curative with primary endpoint of OS with separate sheets for:

  • IF median OS with the standard treatment is < 1 year
  • IF median OS with the standard treatment > 1 year
  • IF median PFS with standard treatment < 6 months
  • IF median PFS with standard treatment > 6 months

Evaluation form 2b - For therapies that are not likely to be curative with primary endpoint PFS with separate sheets for:

  • IF median PFS with standard treatment < 6 months
  • IF median PFS with standard treatment > 6 months

Evaluation form 2c - For therapies that are not likely to be curative with primary endpoint other than OS or PFS or equivalent studies

Read the pivotal articles of the ESMO-MCBS:

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