Digital clinical trials

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Maria De Pizzol, Head of Global Clinical Operations Dompé farmaceutici, talks about how we ensured the continuity of our clinical trials during Covid-19.

In the last two years, the health emergency has contributed to the acceleration of digital health. Digitalization has created the possibility to conduct digital clinical trials to verify the efficacy and safety of new medicines.

Back in March 2020, Milan, where we have our headquarters, was the Italian epicenter of the pandemic. The emergency was unprecedented: as a company, we had to deal with several critical issues in carrying out clinical trials, including the deaths of patients and staff involved in trials, and not least the suffering that everyone felt at such a difficult time. Despite these difficulties, Dompé has always tried to achieve a fundamental objective: to guarantee patients' health. Therefore, we promptly put in place a risk management plan to avoid interrupting ongoing clinical trials. In addition, we started a new clinical trial to evaluate the efficacy of a molecule - registered and already used, on prescription, for osteoporosis in post-menopausal women - to treat mild and paucisymptomatic Covid-19 patients.

"Considering the quarantine regimen patients were forced to follow, we identified and adopted fully digital solutions - explains Maria De Pizzol, Head of Global Clinical Operations - launching a new protocol."

The study allowed real-time monitoring of the patient's clinical situation by using a kit consisting of digital medical devices to monitor blood pressure, heart rate, transcutaneous oximetry, and body temperature. In addition, there were weekly home visits by dedicated health staff. Finally, patients could communicate quickly with the doctor through a tablet provided at the time of enrolment. Data collection and monitoring activities were carried out in close connection with the reference hospitals: Spallanzani (Rome), Le Molinette (Turin), San Salvatore Hospital (L'Aquila), Monaldi (Naples), and Humanitas (Milan and Bergamo).

The pandemic has inevitably led to rethinking how clinical trials are conducted, allowing us to enhance the use of digital in clinical research. "I believe that this completely digital and much more agile approach has become the new normality for Dompé," explains Maria De Pizzol. "I am sure that soon we will enhance everything that the pandemic has allowed us to learn and experiment with."

Dompé farmaceutici S.p.A. Single shareholder company / Share capital € 50.000.000,00
REA MI 289519 - A registered company in Milan, Italy / Tax code and VAT number IT00791570153