HERE IS THE ABSTRACT OF THE PROJECT THE PATH OF HEALTH CONDUCTED BY IQVIA ITALIA.
Never as in the current historical period has it become necessary to provide the population with the basic tools and information to make informed choices and decisions about their health. “The Path to Health” is a project that aims to raise public awareness of the importance and ethicality of Clinical Trials, and has been implemented in collaboration with IQVIA, the largest multinational active as a Contract Research Organization (CRO). The ultimate goal was to devise a campaign to raise awareness of the little-known but very timely issue of Clinical Research.
As the name of the campaign suggests, Clinical Trials are in effect a pathway not without obstacles that leads to progress in the treatment of disease and therefore to the improvement of human life. The complexity of Clinical Trials, which require the testing of efficacy on humans, have always aroused a sort of mistrust in the population. This distrust turned into anger and fear during the Covid19 pandemic, when science was slow to provide a definitive solution to a disease that caused the loss of countless lives in a very short period of time. The absence of unequivocal authoritative opinions and misinformation then contributed to definitively cast a shadow of distrust and skepticism towards the scientific world. In this context, our campaign must be addressed to the general public, in order to promote an informed and conscious participation in research. It was therefore necessary to explore new ways of information and identify the best interlocutors.
Communication is a two-way street, it only works if you listen. For this reason, in the initial phase of our work, we collected different opinions of actors involved in the design and execution of Clinical Trials (representatives of important scientific bodies and associations) by conducting interviews, with the aim of learning about their experience, communicating the initiative and gathering their interest in participating and supporting it.
Dr. Maddalena Pelagalli, President of the RelaCare Foundation, gave us her opinion from the point of view of the world of patient associations, on what are the needs and difficulties faced in the involvement of the patient within the Clinical Trial. We became aware of the importance of associations as a point of reference for the patient in a trial, as a means of communication and direct and effective information for those who suffer from a particular disease and have the desire to improve their quality of life.
Dr. Dominique Van Doorne, president of EUPATI (European Patients’ Academy on Therapeutic Innovation), together with her team has set the goal of providing patients with certified training on Clinical Trials in order to inform them and make them active and aware protagonists. From his work was born the figure of the Expert Patient, who acts as a support for the inexperienced patient and is very important when he has doubts. His involvement in the design of a clinical trial is also fundamental.
The goal of the president, in sync with our intentions, is to bring the project in schools, the educational environment par excellence, up to the university, where the topic is often treated superficially.
Afterwards, in order to have a more direct vision also from the CROs, we had the pleasure to interview Dr. Fabrizio Forini, president of AICRO (Italian Association of Contract Research Organization), who agrees with our project of dissemination underlining its importance especially to counteract the bombardment of notions occurred during the pandemic, very often not accurate and cause of misinformation. AICRO also agreed with our dissemination project, adding that it is necessary to move away from “niche” interlocutors in order to widen as much as possible its audience.
Finally, we had the opportunity to interview the Head of the Research Area of Farmindustria, Dr. Giuseppe Caruso, who reiterated that the objective of dissemination is not to convince, but to give the opportunity to be informed in an informed and free way. Once again, the common intent of starting from schools with substantial information and less technicalities, and then arrive in the clinical and pharmaceutical field with appropriate insights, was manifested. With their initiative “Geni a Bordo” and their activity in the university field with a school of higher education, IANUA, they have an excellent dissemination experience that they continue to pursue. Dr. Caruso emphasized the importance of a structured collaboration with AIFA, the Ministry of Health, and the patients’ association EUPATI to arrive at a more transversal understanding and awareness of what the pharmaceutical sector is and the importance and necessity of Clinical Trials. The goal is to dispel false myths such as the one that people are unwittingly guinea pigs of big pharma or the alleged enrichment of pharmaceutical companies on diseases that would lead them to invent them. A topic that can be discussed with older children is certainly the inclusion of children in the Clinical Trial for PIP (pediatric investigation plan), as well as that on ethics committees and ethical and scientific approval. The meeting with Dr. Caruso has certainly been a valuable starting point for our dissemination project and the common goal of a national capillarity.
In order to gauge the current opinion on Clinical Trials by the population, so as to have a more realistic view of the current situation, we created a narrative tool in which the user can answer generic questions about themselves (age, gender, region of origin, educational qualification) and share their feelings about Clinical Trials, SARS-CoV-2 vaccination, what they wanted to know about Clinical Trials having the opportunity. This tool has been shared online on social channels (facebook, instagram) and through personal contacts via Whatsapp, with the request for maximum dissemination.
We were able to collect the considerations of 265 people, reaching a diverse population in terms of age, background and educational qualifications. For the collection of emotions of users, we have provided as a support and guideline the Plutchik Flower. When asked “What emotions do you feel when it comes to Clinical Trials?” we were pleasantly surprised to learn that one of the emotions most elicited was interest, as well as confidence. However, there was no lack of feelings of anger or dread, and even apprehension about something still unknown to the majority of the population. The majority of users have stated that they have a good opinion of the Clinical Trial, which is considered essential in order to achieve progress in science thus leading to an increase in human life expectancy. We managed to reach some people who expressed distrust or bad opinion. We have also noticed that some people are not clear about what this is all about, since they have asked about the involvement of animals in the studies.
The fact that Clinical Trials are funded for profit raises questions about their reliability, safety and veracity. There is curiosity about the regulatory and ethical aspects, and there is also concern for the patients who participate in the Studies.
We thought that the information and awareness campaign should target the young population, in particular primary and secondary school students and university students, certainly from the scientific faculties, which will constitute a natural reservoir of specific knowledge on the subject, but also other faculties, since reality has taught us that everyone wants to be aware of the process that ultimately affects them. In this phase we have also planned to participate in scientific festivals and events.
In order to reach the older population, the main channels of dissemination are pharmacies, general practitioners and hospitals, relying on the already known confidentiality and authority that the figures present exercise towards their customers and patients, giving the possibility of a direct comparison with a trusted and competent person for the clarification of doubts or concerns.
To reach physicians and principals, the various Regional Health Systems could be contacted, through which they could involve health personnel in a training and information program. With the aim of exercising the most uniform action possible for the involvement of pharmacies, we could contact the trade associations, such as Federfarma.
Finally, we propose a social campaign, for maximum dissemination and amplification. The common element of the campaign is the brochure “The Path to Health”, a real little guide to discovering Clinical Trials. We sketched it as a 10-12 pages booklet containing the main information about the conduct of a clinical trial, with a short but effective final glossary, which defines, in a few simple words, the meaning of the “big words” of science most used in clinical trials.
Citizens need to be informed in a comprehensive manner and by competent people. “The Path to Health” aims to reach them, not to convince them, but to give them the opportunity to reconsider clinical trials as a way to wellness and not to decline. Our project is certainly still in an embryonic definition phase, but the potential for success is very high, given the great demand for information and the scarcity of similar projects. We hope therefore to have contributed in our small way to an important cause, that of knowledge, which is essential and never to be taken for granted, and to have laid the foundations for the realization of one of the first major awareness projects in the field of Clinical Trials. Working on a campaign of this magnitude has certainly been an exciting challenge, in which we found ourselves combining the pragmatism necessary for planning with creativity in defining new ideas.