Madrid, 17 May 2024. Over recent years, Spain has become a benchmark for clinical trials of new medicines. In fact, as we approach the end of the first year of the new mandatory European Clinical Trials Regulations, the annual figures published by the European Medicines Agency (EMA) show that Spanish centres participated in 845 of the 1,944 clinical trials authorized in the European Union. This represents 43% of the total recorded on the new centralized CTIS registries.
As part of the celebration of International Clinical Trials Day on the 20 May, Dr. Fabio Franco, medical oncologist at MD Anderson Cancer Center Madrid and one of the leaders of the Phase I Clinical Trials Unit at the MD Anderson Cancer Center Spain Foundation reiterated that clinical trials are fundamental to the advancement of medicine. In addition, they enable the development of new therapies with beneficial results for people’s health and wellbeing.
"Clinical trials open the way to using drugs that are otherwise unavailable, but are adapted to a specific patient situation. It is a therapeutic opportunity that can help control the disease and improve the patient's quality of life", explains the specialist.
Dr. Franco goes on to argue that the clinical trial is "always a scientific alternative that allows the patient to receive a treatment that is most likely not commercially available".
New lines of research in patients with more specific molecular alterations
The results obtained in clinical trials are fundamental and essential to develop new methods to fight cancer and MD Anderson Madrid uses them to find better ways to prevent, diagnose and treat the disease.
Since its launch in 2021, the center’s Clinical Trials Unit has recruited 1,064 patients and conducted 373 trials. Currently there are 68 studies in progress at the Unit, of which 27 are Phase I, the most complex but with a key role in testing potentially effective molecules.
In addition, the Unit is also involved in advanced Phase II and III trials focused on various types of tumours and drugs. These include chemotherapy agents, immunotherapy techniques and targeted treatments, such as oral or receptor-specific therapies.
In terms of the current lines of oncology research, as Dr. Franco reports: "lung cancer, head and neck cancer and melanoma are among the most prominent within the Unit at the moment". However, he clarifies that studies of other tumours such as those of digestive and gynaecological origin are also underway.
"Clinical trials are becoming more specific and are aimed at particular populations of patients with defined molecular alterations. For example, we are working on the development of new molecules directed against EGFR problems, patients with lung cancer and those with digestive cancer, mainly colorectal cancer”, says the MD Anderson Madrid specialist.
Artificial intelligence (AI) algorithms in the DIPCAN study
The DIPCAN study (Digitalization and Management of Personalized Medicine in Oncology), one of the most promising of the Unit’s initiatives, was launched with the aim of improving clinical practice in the area of Oncology. The idea was to focus on the development of Personalized Medicine through the integration of clinical, genomic and radiological imaging data. Still in the process of recruitment, it already has the participation of 956 patients, and expects to attract 2,000 by the end of the year, which was the goal when the project began.
"The objective of DIPCAN is to implement artificial intelligence (AI) algorithms to identify patients who can be treated in a more disease-orientated way”, explains Dr. Franco.
Artificial intelligence (AI) can detect patients with potential risks, such as thrombosis or lung toxicities. In addition, there are other patient assistance algorithms, including applications capable of interacting verbally with the patient and possibly enabling the discovery of possible side effects of treatments that the patient could miss or that would be unidentifiable on their own, although, he stresses, "These technologies are still in the development phase".