Change in definition ‘Accrual into prospective interventional clinical trials’ Manual 3.0, effective immediately


July 23, 2020 
 

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.