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October 15 – 21, 2021

biomarkers as stratification factors Christoph Grimm

Forums › Topic Group 1 › biomarkers as stratification factors

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    • October 16, 2021 at 12:01 pm #1118
      Kathleen Moore
      Participant

      Probably need to separate prognostic and predictive biomarkers.  We only need predictive if relevant to the asset under study

      • October 16, 2021 at 1:45 pm #1142
        Andreas du Bois
        Participant

        agree with Kathy 100%. We should think about seperating into prognistic marker which should be applied to avoid bias in the trial (as residual disease) and predeictive marker – as indicated by Kathy depending on the asset we are looking at. BRCA and HRD might be important anyway because neede also to define the standard arm treatment (with PARPi)

    • October 16, 2021 at 1:12 pm #1140
      Elise Kohn
      Participant

      I agree, validated biomarkers should be incorporated as relevant to the trial design, whether prognostic or predictive.  But, we should be thoughtful in the number, as stratification factors “cost” in statistical design.

      Collecting such information as associated data, not using for eligibility or stratification (if not pertinent to design), should be encouraged so that we have the broadest view of the trial participant population.

    • October 17, 2021 at 12:31 pm #1198
      Christianne Lok
      Participant

      Although diagnostic, prognostic and predictive markers are all very relevant, there are many forms as also serum, molecular and pathologic/immunohistochemic markers (including timing thereof, as they may chance in time) which should be specified in the protocol but only a minority should be used as stratification factors.

    • October 17, 2021 at 3:44 pm #1211
      Asima Mukhopadhyay
      Participant

      Regarding the statement that PARPI may be used in HRP in the reference arm- do we need to specify following response to platinum to emphasize on the select group as we may may not have adequate data to substantiate this on HRP with poor platinum response

    • October 17, 2021 at 8:44 pm #1227
      Elise Kohn
      Participant

      I think that we qualify that HRD testing (FMI/Myriad) could only be considered for selection or stratification in front line therapy.

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