Clinical research methodology process: what has changed with COVID-19?

Area of Science:

• * Epidemiology and Public Health
• * Clinical Research and Pharmacology
• * Health Informatics and Health Systems

Background:

• * The COVID-19 pandemic caused widespread disruption to ongoing clinical research.
• * Initial research efforts focused on numerous uncoordinated anti-COVID-19 protocols with limited significant outcomes.
• * Early findings identified anti-inflammatory and anticoagulant benefits, highlighting the systemic nature of the disease.

Purpose of the Study:

• * To analyze the impact of the COVID-19 pandemic on clinical research methodologies and outcomes.
• * To evaluate the evolution of therapeutic strategies for COVID-19, from early interventions to specific antiviral drugs.
• * To assess the significance of the new Italian Electronic Health Record (EHR-FSE2) for national health data management and research.

Main Methods:

• * Review of pandemic-related research protocols and publications.
• * Analysis of therapeutic developments, including anti-inflammatory, anticoagulant, monoclonal antibody, and antiviral treatments.
• * Examination of legislative changes concerning health data infrastructure, specifically the EHR-FSE2.

Main Results:

• * Significant interruption of non-COVID-19 clinical studies and a proliferation of low-yield COVID-19 research.
• * Emergence of specific antiviral therapies like Ritonavir-Boosted Nirmatrelvir (Paxlovid), though underutilization was noted.
• * Introduction of the new Italian Electronic Health Record (EHR-FSE2) to replace a non-functional predecessor.

Conclusions:

• * The pandemic underscored the need for coordinated clinical research and efficient data management.
• * While specific therapies have advanced, their uptake remains a challenge.
• * The EHR-FSE2 represents a fundamental shift towards systematic health data collection, with profound implications for public health, epidemiology, and clinical research.