Adnkronos Rome, October 10 (Adnkronos Salute) – "Research has completely changed compared to the past. It used to be something artisanal, and the people who conducted research weren't exactly professionals. Now, having to comply with strict rules of 'good clinical practice,' new research professions actually exist. The problem is: who trains these new figures? To date, there are no specialized degree courses, and the few master's degrees that exist lack the professionalizing phase.
The first challenge for modern research therefore concerns the training of new professional coordination figures, study coordinators, and research nurses. "Without these figures, research cannot be conducted," said Antonio Gasbarrini, scientific director of the Fondazione Policlinico Università A. Gemelli IRCCS in Rome, speaking at the Investigator's Meeting held in Rome on various areas of clinical research conducted by AstraZeneca in Italy.
In clinical research, "the relationship with companies," explains Gasbarrini, "must be a strategic alliance where everyone must do their part: the doctor, the research organization, is in some way the patient's guarantor" that "the particular drug" developed by a company "is truly innovative compared to the standard and, above all, must guarantee its safety. Institutions, companies, and hospitals that work together with the goal of improving patients' health must be allies," he specifies, "not competitors. The strategic alliance between doctors, patients, and companies" acts for the good "of the patient and society." In this regard, to understand the real needs of patients and transfer knowledge to research, "we should return to the medicine of the past. We don't treat organs, but we treat patients," Gasbarrini emphasizes. "This is also true in the design of clinical trials. Regulatory agencies are now helping us" because "they believe that the patient's well-being, the treatment as a whole, must be guaranteed. The patient's overall well-being must be put first. However, this is done with different indicators than in the past."
In this context, "comprehensive patient care must be the primary endpoint," the clinician emphasizes, "and digitalization is a huge asset. When patients enter hospitals, all their data is now digital. Any large facility right now could, on paper, immediately identify patients for a study by simply inserting inclusion and exclusion criteria into our patient records." It should be considered that, for some very common conditions like heart failure, diabetes, and insulin resistance, "we have patients who go to many different units" with vast amounts of data and opportunities for enrollment and research. "This," Gasbarrini concludes, "would give us a huge advantage within the Italian system."