Facts and figures of the compassionate use of onco-hematological drugs from 2016 to 2021: Results from the multicentric observational study Compass-O.

BackgroundCompassionate drug use (CDU) is a topic of debate in the scientific community characterized by a lack of information, especially in the onco-hematology area.AimThe Compass-O study aimed to provide updated data on CDU of onco-hematological drugs for the period 2016-2021.MethodCompass-O is a retrospective observational study with data obtained from 7 Italian Units for cytotoxic drug preparations ().

The Early Access and the Potential Cost Savings by the Compassionate Use of Onco-haematological Drugs: Results from the Italian Study Compass-O.

Background: Compassionate drug use (CDU) provides early access to not yet authorised medicines and is funded by pharmaceutical companies. The observational retrospective study Compass-O monitored the CDU of onco-haematological drugs, managed by seven Italian units for cytotoxic drug preparations (Unità Farmaci Antiblastici [UFA]), between 1 January, 2016 and 31 December, 2021.

Objective: We aimed to evaluate the CDU of onco-haematological drugs managed by seven Italian UFA, between 2016 and 2021.

Project R. Evolution for improving clinical research in Italy: challenges and strategies.

Objective: The R.Evolution project aimed to reach a consensus on the main challenges of conducting clinical research in Italy and possible strategies and approaches to address them and optimize clinical research management.

Methods: A scientific board of experts initially discussed potentially critical areas in clinical research conduct and further explored them through an online national survey.