The healthcare crisis triggered by the Covid-19 pandemic highlighted the importance and commitment of the pharmaceutical industry to the research and development of new medicines. In fact, in the field of clinical trials, it meant an acceleration in the digital transformation of R&D&I for new medicines, taking advantage of available technology and healthcare data to bring clinical trials closer to the patient’s home in a context of increasing decentralisation of clinical research.
“Bringing clinical trials closer to the patient’s home allows for better recruitment and inclusion of a more diverse population, resulting in better scientific quality of study data. In addition, this type of study not only saves travel for patients and monitors, but also provides greater flexibility for all those involved in the research process, as well as better follow-up of study participants”. This was reflected by Farmaindustria’s Associate Director of Clinical and Translational Research, Amelia Martín Uranga, at the conference The home is the new hospital, recently organised by IESE Healthcare in Barcelona, which focused on key new trends in technology and how to reshape the healthcare of the future.
Several of these measures, he stressed, were already adopted during the Covid pandemic and now regulators are working to ensure that they can be sustained over time, in line with the recommendations document published under the ACT EU initiative, a project led by the European Commission, the European Medicines Agency and the Network of Heads of Medicines Agencies. “This initiative is an important first step towards clarifying the use of decentralised clinical trials in the European Union by the European medicines regulatory network. The document addresses the roles and responsibilities of both sponsor and investigator in terms of electronic informed consent (eConsent), delivery of investigational medicines to the patient’s home, remote monitoring and other elements that aim to bring the trial closer to the patient’s home, while ensuring the rights and welfare of patients, as well as the integrity and reliability of the data collected,” he said.
Farmaindustria is also working in this area, he said, which has an ad hoc group that has been working on different decentralised elements in order to advance the development of a national guide on the application of decentralised elements in clinical trials with medicines. This group is also working with an autonomous community that is interested in establishing standardised working procedures for networked clinical trials by its centres, said the Farmaindustria spokeswoman.
This digital transformation of clinical trials is taking place at a time when the Proposal for a regulation on the European Health Data Space is being discussed. The pharmaceutical industry sees this regulation as a great opportunity to improve healthcare for European citizens by ensuring the continuity of treatments and the widespread availability of their clinical information in secure environments. “To this end, it is essential to enhance public-private collaboration. Bringing clinical trials closer to the patient’s home is a challenge in which the public and private sectors must work hand in hand. As the pandemic has already shown, cooperation between industry, research centres and healthcare professionals is the best formula for accelerating and promoting the arrival of new innovative medicines to society,” he concluded.