To examine the European landscape of clinical trials and the regulatory framework for Digital Therapeutics (DTx), focusing on the current situation in Italy, as part of a narrative review.
Approach:
Key Findings:
13 DTx-related clinical trials were identified in Italy, including 11 interventional and 2 observational studies.
All interventional studies were randomized controlled trials with varying control arm strategies, including standard of care and digital placebo conditions.
The European Medical Device Regulation now recognizes stand-alone software as a medical device, emphasizing regulatory compliance.
Interpretation:
The integration of DTx into healthcare systems will depend on clinical evidence, regulatory adaptation, and user engagement.
Limitations:
The regulatory framework for DTx in Italy is less clearly defined compared to other European countries, such as Germany and France.
Market entry challenges exist due to national-level evaluation and approval processes.
Patients with preoperative vitamin D deficiency had higher postoperative pain scores and opioid use after mastectomy, including more than triple the odds of moderate to severe pain within 24 hours of surgery.
A prespecified exploratory analysis of the FIND-CKD clinical trial examined kidney function, albuminuria, and kidney failure outcomes in 903 patients with glomerular diseases.
