Clinical research: who are the 'champions' of new drugs, but competition is fierce

Attracting clinical trials to Italy - that is, the testing of a new therapy in a group of patients - certainly has a great economic weight, which so far for Italy is worth around 700 million a year. "But the other enormous value is that we ensure many of our patients who may not have any chance at all drugs that will be available in as little as 10 years' time," warns Antonio Gasbarrini, dean of the Faculty of Medicine at the Catholic University and scientific director of the Gemelli Hospital in Rome, who turned the spotlight on clinical research on the date of the International Clinical Trials Day. In fact, on 20 May 1747, the first trial in history, the one conducted by James Lind on the sailors of a British Crown ship, was launched to find a therapy against scurvy.

After more than 250 years and so many drugs that have changed the lives of so many patients and the course of so many pathologies, the world of trials of new treatments is experiencing an incredible acceleration: 'Thanks to trials,' Gasbarrini explains, 'drugs with a deflagrating scope such as immunotherapeutics and Car-Ts have been tested, which have made neoplasms for which there were previously only a few months to live chronically curable. New classes of drugs have changed the course of diseases such as diabetes, while antivirals have eradicated hepatitis C, reducing the need for liver transplants'. In short, a revolution on which Italy - which has a great tradition in clinical research - cannot afford to lag behind, and to do so it not only 'must be quick in setting up studies, cutting red tape, but must also make sure it has innovative professional figures to assist the principal investigator doctors who coordinate the trials,' Gasbarrini warns. These figures have now become key figures able to work alongside doctors, to conduct studies according to the increasingly complex standards and requirements of the new EU rules that Italy only transposed with great delay in 2023: they range from new research nurses to study coordinators.

"By now, pharmaceutical companies that want to carry out trials when they make their visits to the centres where the trials are carried out among the first things they check their presence. If you don't have them, there is a high risk of not being selected,' warns the doctor, who in his life has followed 'hundreds' of studies with Gemelli, which is among the main hubs in Italy for clinical research. "We have invested a lot in order to have the infrastructural requirements of a centre that can also host trials from Phase 1, which are done very little in Italy and which are those that have to demonstrate the safety of therapies, studies that can be crucial to host the other more advanced phases of trials," adds Gasbarrini, who now calls for the activation of structured training courses (not just master's degrees) for these new professionals. 'The rules of the game are increasingly complex and it is not enough to have a good doctor. In order to guarantee fast, ethical and quality clinical research,' explains Vincenzina Mora, coordinator of the Clinical Trials Day organised today and tomorrow and head of the Gemelli Clinical Trial Office, 'crucial figures are needed, such as the study coordinators, who are in charge of the all-round coordination of all the activities envisaged in the research protocol, and the study nurse, a nurse capable of administering and managing an experimental drug. Now the aim is to include these paths in undergraduate and postgraduate courses, also in order to guarantee adequate professional training activities, which are indispensable for entering the world of work immediately'.

"From 2022 to date, the period of full implementation of the new European rules on clinical trials, there are more than 2650 clinical trials authorised in Italy according to the data reported by Ema," emphasises Marcello Cattani, President of Farmindustria. "With investments by pharmaceutical companies of around EUR 800 million every year. A value for citizens, who can access innovative therapies, for the National Health Service, which registers an overall benefit of 3 euros for every euro invested by companies. And for doctors and researchers, who have at their disposal state-of-the-art tools for the constant updating of skills'. According to the President of Farmindustria, Italy can therefore do its part with the many excellences it has: "Companies, human resources, universities, research centres, hospitals, the NHS, health workers. And thanks to the reforms carried out by the government to strengthen life sciences, we can really be even more of a protagonist on the international scene, not least by speeding up the procedures for activating clinical trials. Today, competition is fierce at European and global level, with countries adopting targeted policies to attract more and more investment in health. Europe,' Cattani concludes, 'has lagged behind over the last 20 years in terms of investment in R& D, with its share falling from 41% to 31% of the total of the major economies. In the same period, the share of the United States has risen from 44% to 52% and that of China from 1% to 8%. It must therefore catch up, with a more attractive environment for investment and by strengthening intellectual property, as the other major world ecosystems are doing'.

The fact that there is no time to lose is clear from the increasingly fierce competition between countries. According to the online platform of the European Medicines Agency (EMA), there are now just over 8,600 clinical trials underway in Europe, followed by Germany with 1,632 coordinated trials, France with 913, and then Italy with 645 clinical trials. But close behind is Spain, which is growing steadily with 619, so much so that it may soon overtake us: 'They are quick to start up, thanks in part to legislation that has had several revisions made precisely to be more attractive to pharmaceutical companies. This is also why, together with the Ministry of Health, we are working on a single text on pharmaceuticals that will bring order to the mountain of regulations in the sector and at the same time make Italy more attractive for trials,' warns microbiologist Guido Rasi, pharmaceuticals consultant to the minister Orazio Schillaci.