Source: www.farmaindustria.es
The Covid-19 crisis has highlighted the importance of the digital transformation of healthcare, both in healthcare and in research. On this last point, our country has placed itself at the forefront of Europe in terms of the number of clinical trials launched in hospitals to test the efficacy of drugs against the virus. “We have been a reference in the clinical trials of the Covid-19 and now we have to take advantage of this position of advantage to get more investment to Spain in the field of clinical research.” This was stated by Amelia Martín Uranga, head of Farmaindustria’s Platform for Innovative Medicines, at the online Forum Covid-19. Strategies for health research, organized by the Microsoft-University of Valencia Chair of Privacy and Digital Transformation, with the collaboration of the Spanish Professional Privacy Association, which was held this Friday.
“This crisis has allowed us to break some barriers, such as monitoring clinical trials remotely, without having to be in person, and it has also forced us to accelerate digital processes that we were already implementing. Many of the changes that Farmaindustria has worked during the pandemic together with the Spanish Agency for Medicines and Health Products (Aemps) and the Spanish Agency for Data Protection in the field of digitization of clinical trials have come to stay, “he assured. Martín Uranga.
Thus, among these changes introduced, the implementation of informed consent by telematic means stands out, and especially, remote monitoring with verification of source data. “Until now, these novelties were for trials related to Covid, but now, as we had requested from Farmaindustria and it was a request from many of the researchers and patients, since June 29 the Aemps has gone one step further and allows This monitoring of remote trials is allowed for Phase I clinical trials of first administration in humans and for all trials investigating treatments for serious diseases without therapeutic alternatives, provided that the guarantees adopted by the Spanish Agency for the Protection of Data”. These changes represent a great advance, according to Martín Uranga, “and place Spain in a better position of competitiveness with other countries when it comes to attracting new clinical trials to our country.”
However, the head of the Innovative Medicines Platform of Farmaindustria has highlighted that currently there are few hospital centers in Spain that are prepared to offer this type of remote monitoring. “A fundamental part of this initiative depends on the centers being able to comply with the technical security protocol,” he explained. For this reason, from Farmaindustria we are going to coordinate a working group in the autumn with the centers so that they can show their needs and that the most advanced hospitals in this field can share their best practices in this field with others. ”
She has also highlighted the steps that are being taken in the country in favor of digitization in health. In this sense, she stressed that the Digital Agenda 2025, the Government’s roadmap for the coming years, will incorporate as its own the macroprojects in key sectors such as health, in which Farmaindustria will participate along with other employers in the health and ICT sector,. will pursue a true digital transformation of the health sector aimed at improving access, efficiency, effectiveness and quality of biomedical research and healthcare processes, with a key role for the patient in managing their health
Lastly, the representative of Farmaindustria has defended that the promotion of biomedical research must take place in parallel with an adequate data protection system for citizens, always seeking a balance between the two. In this sense, she recalled the value of codes of conduct, as an element of self-regulation for the sector in an area such as clinical research and pharmacovigilance in which the Association works. Adherence and effective respect for a code of conduct are a guarantee of responsibility and regulatory compliance with protection and, in turn, greater protection for subjects. The adhered entities will ensure a higher level of compliance and, on the other hand, will project a corporate security image, as happened with the previous Type Code.
The health crisis has fueled the digital transformation of healthcare. In this as in the rest of the sectors we have had to adapt to the new times. Distefar supports this transformation and becomes part of it.