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4CPS-389 Governance of clinical trials between health needs, access to care, innovation and sustainability in the COVID-19 pandemic era
  1. M De Fina1,
  2. M Zito1,
  3. MD Naturale2,
  4. S Esposito1,
  5. C Monopoli1,
  6. A De Francesco1
  1. 1Azienda Ospedaliera Universitaria ‘Mater Domini’, Hospital Pharmacy Unit, Catanzaro, Italy
  2. 2’Magna Graecia’ University, Hospital Pharmacy School Resident, Catanzaro, Italy


Background and importance In the constantly evolving new regulations for clinical trials, the hospital pharmacist is more and more involved in clinical trials.1 In the current context of a deep economic crisis, clinical trials represent an important aspect of healthcare, especially for access to the latest generation therapies.

Aim and objectives The aims of the study were to provide an overview of the governance of clinical trials and to estimate the cost savings generated by unused resources, attributable to the provision of drugs used in phase IV trials and for ‘compassionate use’.

Material and methods A retrospective study was conducted on clinical trials started between 1 July 2016 and 30 June 2020 in hospital settings. Characteristics analysed were phase and type of study, drug (according to anatomical chemical therapeutic classification (ATC)), method of storage and route of administration. The first arrival of supplies was considered as the index date. The savings were calculated by monetising supplies for phase IV and ‘compassionate use’. Costs estimated considered the ex-factory cost (excluding VAT), net of temporary legal reductions, where applicable.

Results During the study period, 129 clinical trials were evaluated (phase I (1.2%), phase II (16.7%) phase III (54.9%), phase IV (10.9%) and ‘compassionate use’ (16.3%)): 44.44% were international multicentre trials and 92.6% were randomised blinded trials (double blind=22.4%). 188 different drugs were involved (70.5% stored at 2–8°C); solid oral formulations (11.78%). Phase IV trials involved eight drugs (ATC: A10A; B01A; J05A; L01C; L01X; N02C; N07X); ‘compassionate use’ involved 12 drugs (ATC: L01XC=93%; L01XE=5%; other=2%). The overall savings was 1 046 341.79€ (compassionate use=85.61%). In the first semester of 2020, savings were 309 736.00€. In particular, savings were related to use of ATC:L01X (93.81%) and ATC:N02C (6.19%). In the first semester of 2020, with the pandemic in progress, 2.48% of trials in the digestive pathophysiology area (29/129) saw at least one referral to the patient‘s home.

Conclusion and relevance Clinical research generates not only economic value for the health system, but also clinical benefits related to the availability of innovative therapies. This study showed that the care system for clinical trials worked even during an unprecedented health emergency. Thanks to the collaboration of all the health professionals involved, no ‘lockdown effect’ resulted in detriment to the patients enrolled in clinical trials.

References and/or acknowledgements

  1. De Fina, et al. IJMSBR 2020;07:01–08.

Conflict of interest No conflict of interest

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