Clinical research and clinical trials are making unprecedented progress, driven by cutting-edge technologies, such as Artificial Intelligence (AI), which allows for large amounts of data to be collected. Óscar Salamanca predicts that, in less than a decade, a ‘major change’ will have occurred in how clinical trials are managed or in the aspects needed to approve a drug.
This was a compelling reason for the new European regulation on clinical trials, which promotes multi-centre and multinational research at European level through a single approval, that is centralised in the Clinical Trials Information System (CTIS).
This modification of the clinical research environment allows a drug to be approved with a phase II study, overlapping research phases II and III, new types of design, such as basket or umbrella-type trials, or the use of Real World Data.
The expediency during the start-up process of clinical studies makes Spain a powerful country worldwide, highlights Óscar Salamanca. Further reasons are that there is a sufficient population of patients, there is a public hospital network that is acutely aware of the need to conduct clinical research and there are many Spanish investigators who are highly renowned worldwide. Hospitals have, in most cases, been able to prepare for this demand, and Salamanca welcomes the fact that infrastructures have been put into place to accommodate this research, which has advanced Spain compared to the other neighbouring countries. All this means that patients participating in clinical trials in Spain have access to the latest therapeutic innovations.
However, not all aspects are positive in Spain, where each autonomous region deploys a specific model for collecting information, which means there are different models, unlike in other countries, which makes it difficult for the understanding of the situation of the diseases at country level. Other areas for improvement relate to access to medicines, once they are authorised, both at country and autonomous regions level.
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