Italians have faith in scientific research, but express concern and fears about clinical studies – fundamental for innovation and scientific progress – also due to fake news and ‘false myths’. Promoting awareness among citizens of the value of research and overcoming the resistance that hinders patient participation in clinical trials are the objectives of the national awareness and information campaign on the value of research and clinical trials ‘We are research. All together, from science to cure’, promoted by the Eupati Aps Expert Patient Academy (AdPee) together with an authoritative and broad coalition of 47 patient associations, academies and healthcare companies, scientific societies and research centres, with the patronage of the Agostino Gemelli Irccs University Polyclinic Foundation – Catholic University of the Sacred Heart, of the related Clinical Trial Center and of the University Hospital of Alessandria. The initiative was presented today, in a meeting sponsored by the Higher Institute of Health and Farmindustria.
The Eupati Expert Patient Academy “has always believed it was important to address citizens’ concerns regarding clinical trials – declares Nicola Merlin, President of AdPee – we believe it is essential to combat fake news, highlight the value of participation in clinical trials (both for the advancement of science and for the potential benefit of the participants themselves), involving patients so that they can be active protagonists in decisions regarding their health and their treatments. This campaign intends to build a ‘bridge’ of trust between the scientific community and public opinion: ‘research is us’ is an important step towards greater collaboration and mutual alliance, key elements for the progress of science and public health” .
Clinical research – we read in a note - represents an opportunity for patients, as it allows access to the most advanced therapies and contributes to the development of better treatments for all. Italy has always had a leadership role in clinical research, above all due to the excellent quality of scientific production, recognized internationally. Unfortunately, funding is insufficient in our country. “In Italy, in 80% of cases, the studies are ‘profit’, i.e. supported by pharmaceutical companies and only 20% are ’non-profit’, i.e. so-called academic studies – states Giampaolo Tortora, Director of the Comprehensive Cancer Center, Fondazione Policlinico University ‘A. Gemelli’ Irccs of Rome – the lack of unsponsored studies is a serious damage, because the testing of new drugs brings advantages from a scientific and economic point of view. It has been shown, in fact, that for every euro invested in research, the profit for the National Health Service is equal to 3 euros and, in the case of clinical trials for oncology drugs, even 3.35 euros”.
Scientific research is not a distant or exclusive process. Its goals and successes are the consequence of a process shared by doctors, scientists, researchers and patients, united in the common goal of improving the health of the community. Pre-clinical testing is essential to ensure that investigational drugs have an acceptable safety profile and a good chance of being effective. Clinical studies on humans are the tools on which the actual development of a new drug is based. Their objective is to verify and evaluate the safety, absolute priority, and effectiveness of a new molecule through phases 1, 2, 3 and 4 (pharmacovigilance), before it becomes a drug available to patients.
“The process is very slow, gradual and can last up to ten years; healthy subjects or patients participating in a clinical study must always express their consent – explains Dominique Van Doorne, Treasurer and Scientific Director of AdPee – without good patient participation in clinical studies there would be no research. The idea of the ‘guinea pig’ patient is obsolete and outdated, today the patients involved in clinical trials are followed with great attention and rigor. The Ethics Committees are the bodies that control and guarantee that the research is carried out in compliance with the participants and the international rules dictated by the Declaration of Helsinki and the Good Clinical Practices, or Gcp”.
The expert and aware patient is a central figure in clinical research, because he knows the disease from personal experience and is capable of representing the patients’ interests with the skills he has acquired. The patient makes the difference because he makes his knowledge available to the scientific community and contributes to defining the most important clinical endpoints from the patient’s point of view and to evaluating the precious data on the quality of life with the disease. “Being an informed patient means understanding the value of the research and how safe it is, it also allows you to understand the importance of active participation and the need to remain in the study until its conclusion – underlines Paola Kruger, scientific director of Corso Eupati Italia and expert Eupati patient – therefore, correct information is the basis for being able to consciously participate in clinical research. Training, however, gives the patient the opportunity to be involved – from the beginning – in the design of the project, in the development of the clinical protocol and subsequently in the collection of data generated by the patients”.
Research is the human and economic capital of a State. To enhance clinical research in Italy it is essential to: attract economic capital and investments, train staff, retain and attract young talent. “According to the AIFA 2023 Report on clinical trials of medicines in Italy, from 2000 to 2022 over 15,400 clinical trials were authorized in the country – comments Onofrio Mastandrea, Farmindustria Council – in 2023 pharmaceutical companies allocated 2 billion euros to R&D, 7% of total investments in the country. However, critical issues remain: the reduction in clinical trials carried out in Europe, from 18% of the global total in 2013 to 9% in 2023, has led to 60,000 fewer patients accessing a trial and therefore innovative therapies. However, the collaboration between the Ministry of Health, Aifa and stakeholders in the sector has the aim of improving Italy’s attractiveness for clinical research. Investment in human capital is fundamental: the ability to train, retain and attract young talents who will constitute the future of scientific research, also in the pharmaceutical industry”.
Patient engagement in a clinical study follows a precise and very rigorous process which ends with the patient’s informed signature on the informed consent. Alessandro Barcherini of the MelaVivo association thus testifies to his experience within a clinical study: “With the help of the medical staff I took all the steps to get to the first day of treatment and with them I began this journey with trust and hope of participation in the clinical study, which continues to this day, 10 years later. The disease seemed easier to deal with, participating in the study gave me the opportunity to live with it with an excellent quality of life. To those who start a therapy within a clinical study, I would like to say to trust the researchers and doctors and ask them questions without problems, and then with confidence and hope in the future follow all the necessary steps to get to the end ”.
The national campaign “We are research. All together, from science to cure” makes use of various resources whose contents have been developed with the participation of Eupati patients. Through informative videos with scientific communicator Marco Cattaneo and testimonies from expert patients, the campaign helps to understand how clinical research works, how participants are protected and what role associations have. All information and resources for the campaign are available on the landing page. The campaign is created with the non-conditional sponsorship of Chiesi, Pfizer, Roche, Alfasigma, BeiGene, Daiichi Sankyo, AstraZeneca.
How does public perception influence patient participation in clinical trials?
Time.news Interview: Overcoming Challenges in Clinical Research in Italy
Time.news Editor: Welcome, everyone, to this special interview. Today, we have the privilege of speaking with Nicola Merlin, President of the Eupati Aps Expert Patient Academy. We’re here to discuss the recent national awareness campaign titled “We are research. All together, from science to cure,” which aims to bridge the gap between the scientific community and public perception regarding clinical trials. Nicola, thank you for joining us.
Nicola Merlin: Thank you for having me. It’s a pleasure to be here to discuss such an important topic.
Time.news Editor: To start, many Italians express faith in scientific research yet harbor concerns about clinical studies. What do you think are the primary reasons behind this skepticism?
Nicola Merlin: That’s a crucial question. Many concerns stem from misinformation, commonly propagated by fake news and persistent myths about clinical trials. It’s essential to combat these narratives with clear, reliable information to promote genuine understanding and engagement. This is where our campaign plays a pivotal role.
Time.news Editor: Can you elaborate on the objectives of the campaign? What specific actions are being taken to enhance awareness?
Nicola Merlin: Absolutely. Our main goals are to raise awareness about the importance of scientific research and to encourage patient participation in clinical trials. We aim to educate citizens about the direct benefits that come from participating in clinical studies—not just for scientific advancement but also for their potential personal health gains. Through seminars, informational materials, and partnerships with various organizations, we strive to foster a trusting relationship between patients and the scientific community.
Time.news Editor: You mentioned that participation is crucial for the advancement of science and public health. Giampaolo Tortora pointed out that the majority of clinical studies in Italy are supported by pharmaceutical companies, with only 20% being non-profit. What implications does this have?
Nicola Merlin: That’s a pressing issue. When 80% of our studies are profit-driven, it often limits the scope of research towards profitable outcomes rather than addressing pressing health needs universally. There is a clear need for more non-profit, academic studies to explore areas that might not have the same commercial appeal but are vital for patient care and scientific progress. Encouraging a balance will not only benefit patients but also contribute to the overall health system’s sustainability.
Time.news Editor: Creating that balance sounds essential. Dominique Van Doorne emphasized the role of ethics committees in clinical trials. Can you tell us more about the ethical considerations in modern clinical research?
Nicola Merlin: Certainly! Ethics committees are fundamental in ensuring that the rights and welfare of participants are upheld throughout the research process. They oversee the research to ensure compliance with the Declaration of Helsinki and Good Clinical Practices. Today’s clinical trials emphasize patient safety, informed consent, and rigorous monitoring, which collectively help to dispel the outdated notion of participants as mere ‘guinea pigs’.
Time.news Editor: It seems empowering patients is a significant aspect of this. Paola Kruger highlighted the informed patient’s role in research. How are you working to transform patients into active contributors to the research process?
Nicola Merlin: We recognize that informed patients are invaluable to clinical research. Our initiative includes training programs to educate patients about the research process, helping them understand their rights and the importance of their participation. We want them to engage not just as subjects but as collaborators in shaping research priorities and endpoints that matter most to them.
Time.news Editor: With training and empowering patients, how do you envision the future of clinical research in Italy?
Nicola Merlin: A future where collaboration between patients and researchers is the norm rather than the exception. We hope to enhance Italy’s reputation as a leader in clinical research, fostering an environment where ethical considerations lead the way, and patients are encouraged to participate actively and confidently. By attracting economic investments and nurturing young talent, we can ensure that Italy remains at the forefront of scientific innovation.
Time.news Editor: if you could share one message with the citizens regarding the importance of clinical trials and scientific research, what would it be?
Nicola Merlin: I would say this: Your participation matters. Clinical trials are not just about future therapies; they are about creating a healthier present for all of us. By getting involved, you are not only contributing to scientific advancements but also potentially accessing cutting-edge treatments that could improve your health and quality of life.
Time.news Editor: Thank you, Nicola, for sharing your insights today. It’s clear that enhancing patient participation and building trust is essential for the future of clinical research in Italy.
Nicola Merlin: Thank you for having me. Together, we can create a more informed and engaged community when it comes to scientific research.
Time.news Editor: And thank you to our viewers for joining us in this enlightening conversation. Stay tuned for more updates on health and science!