E-Newsletter - April 2018

Conversion of CTCAE v4 to CTCAE v5
Impact on Alliance Trials  

Expedited AE Reporting Using CTEP-AERs

  • Effective April 1, 2018, all expedited AE reporting (via CTEP-AERs) will be done using CTCAE v5. Protocols will be updated throughout 2018 to reflect this change.

Routine AE Reporting

  • By March 31, 2018, the trial A071102 that contained the original Rave-CTEP-AERs integration will have the integration removed. Sites will continue to enter their routine AE data using the same form in Rave. Expedited AE data will continue to be reported directly via CTEP-AERs. Routine AEs reported in Rave will no longer need to be submitted for rule evaluation.
  • For new trials activating after June 1, 2018, routine AE reporting will occur using CTCAE v5. Protocols will reflect this change.
  • By July 31, 2018, the three Alliance trials that have the Rave-CTEP-AERs integration will be migrating routine AE data from CTCAE v4 to v5 within Rave. Once the migration takes place, both routine and expedited AE data will be reported using CTCAE v5. Protocol amendments will be issued for these trials to coincide with the change:
    • A091605: A Randomized Phase II Study Of Anti-PD1 Antibody [MK-3475 (Pembrolizumab)] Alone Versus Anti-PD1 Antibody Plus Stereotactic Body Radiation Therapy In Advanced Merkel Cell Carcinoma
    • A031501: Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma (AMBASSADOR) vs Observation
    • A021502: Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy of Patients with Stage III Colon Cancer with Deficient DNA Mismatch Repair (ATOMIC trial)

Full CDUS Reporting

  • This will be handled by the Research base staff and will not impact Alliance sites.


For other articles in this issue of the Alliance E-News newsletter, see below.