IN PARTNERSHIP


r ill  a inificant can in rarc and clinical


trial in l tan tn ar The expediency during the start-up process of clinical studies makes Europe a powerful continent worldwide. There are, however, obstacles yet to be overcome, such as regional disparity at infrastructure level and the ordeal for patients to get access to recently approved drugs.


C


linical research and clinical trials are making unprecedented progress, which has led Óscar Salamanca, APICES CEO,


to predict 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.


The critical driving force for this change lies with cutting-edge technologies, such as Artificial Intelligence AI, which already enables collecting vast amounts of data from different sites and which motivates new types of design, such as basket or umbrella-type trials, focused on collecting a lot of patient data in a very simple way to make them available as soon as possible to healthcare professionals and sponsors of clinical trials. This new paradigm is already seen in areas such as oncology, where personalised medicine is increasingly prevalent due to the unique characteristics of each patient, making it necessary to condct very specific trials, in which a large number of sites from several countries participate, which is necessary for these clinical trials. This was a compelling reason for the new European regulation on clinical trials implemented in January 2022. This regulation promotes multi-centre and


multinational research at European level through a single approval that is valid for all participating sites and countries. Everything is channeled through a reference country following interstate mtal recognition that conducts and coordinates the evaluation. The documentation until approval from the participating sites and countries is centralised


in the linical Trials Information ystem TI. This provides access to patients needed for a trial due to the individual nature of any condition that would otherwise take much longer. However, a single and consensual model is needed to improve the administrative part in starting the clinical trial, an aspect in which work has been in progress for years. In many cases, there is also the possibility of overlapping research phases II and III, as has already occurred in some drugs approved in phase II while awaiting reslts in phase III for which, due to their very good results in phase II, the health athorities decided to approve. There is no doubt technology makes medicine based on eal orld ata  possible, which is becoming a trning point It will ensure we have real patient data, and it will not just be a patient experiment extrapolated to a population through a statistical method but instead we’ll have increasing access to real data. Therefore, the quality of the information


rather than the quantity is gaining ground in the concerns of those involved in the clinical trials professionals, sponsors, and health athorities. It is not so mch a estion of increasing patient survival, but for the patient to have a good quality of life. Ultimately this means that, when drugs are approved, the health authorities increasingly consider including the patient experience and patient associations. This will become more significant.


pain id rlt pain is at the forefront in condcting clinical trials, and for several reasons. On the one hand, there is a sfficient poplation of patients,


Outsourcing In Clinical Trials | 15


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