Clinical studies, decentralization and technology: a necessary evolution and at the same time a challenge that requires courage!
A few days have passed since the workshop ‘Decentralised clinical trials: practical challenges for the integration of digital technologies, medical devices and telemedicine’, organised by AICROplus – Associazione Italiana delle CRO e dei Service Provider per la Ricerca Clinica e SIT – Società Italiana di Telemedicina..
Decentralisation is not only a technological advance, but also a cultural change that requires vision, collaboration and courage on the part of all those involved in clinical research.
Many tools are already available: centralised laboratories and readings, electronic diaries, IWRS platforms, digital medical records, mobile devices and the growing attention of regulators.
In recent years, there has been much talk about Decentralised Clinical Trials (DCTs). However, it may not be entirely correct to consider them a separate category of studies. More realistically, clinical research is undergoing a process of progressive integration of digital technologies, which is making studies increasingly flexible, inclusive and patient-centred.
This evolution brings with it significant challenges:
✔ Validation of methods
✔ Patient training
✔ Coordination of suppliers
✔ Privacy management
✔ Dialogue with Ethics Committees and Competent Authorities