When working on the revision of the
standards in 2019, the OECI A&D Board decided to
consider changing the indicator for the Percentage of patients included
in clinical trials. This was based on remarks
made during the session during the Oncology Days in June 2019 in Bari,
indicating that the definition did not take into account some developments
related to biomarker-driven studies. However, after evaluating the first
preliminary designations, the OECI A&D Board has concluded that the new
definition for Manual 3.0 may be subject to different interpretations and
therefore hard to use for benchmarking purposes. After extensive deliberations,
the OECI A&D Board has decided to change the definition of the inclusion
rate of clinical trials, and only count the patients included in the Phase
I-III interventional clinical trials. The 10% threshold for CCCs in the
Designation Form remains unchanged; as before, the
research criteria are considered in the round for designation purposes.