WHITEPAPER AND PRESS

The challenge of recruiting suitable patients into clinical trials has always been a significant obstacle to drug and medical device development programs. The difficulty of generating evidence delays the introduction of new medical interventions and entails high costs. In a new Covid-19 context, the pharmaceutical industry is facing unprecedented pressure.

Over the course of two years of the pandemic, heated debates have followed on the safety and efficacy of anti-Covid-19 vaccines. Even today, after over 7 billion doses administered, problems continue to emerge on the available clinical evidence (Il Tempo). The news often reported by the secular press creates concern and perplexity in the population.

Italy has recently instituted substantial changes in the national legislation on the supervision of medical devices in order to align our procedures with the European Regulations 2017/475 for medical devices and 2017/476 for in vitro diagnostics. 

Research and innovation are based on rigorous clinical trials involving patients firsthand. The main actor in clinical trials is the patient affected by the disease under examination. Including the patient’s perspective allows us to reduce barriers that otherwise limit your participation and to introduce tools and support that provide patients with the best possible experience. 

If well designed, observational studies and registries produce treatment effect data comparable in importance to those in randomized controlled trials, generating information missing in traditional interventional studies and real-world data to support marketing authorization.

After more than 20 years, new legislation, the “Medical Device Regulation” (EU-MDR 2017/745), has come into force in Europe. The triggers for the initiation and implementation of this European law, which is much stricter than previous directives, were scandals related to the safety of medical devices because they required a second surgery in a very large number of patients.

Research and innovation are based on rigorous clinical trials involving patients firsthand. The main actor in clinical trials is the patient affected by the disease under examination. Including the patient’s perspective allows us to reduce barriers that otherwise limit your participation and to introduce tools and support that provide patients with the best possible experience. 

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