HPV-FASTER-Implement aims to improve cervical cancer (CC) prevention. Although human papillomavirus (HPV) vaccination and CC screening programmes have significantly reduced mortality, they have reached a plateau because they remain largely inaccessible and underused by vulnerable populations, creating inequalities in the European healthcare system. This adds to the difficulties already faced by vulnerable populations in their efforts to maintain their mental and physical health. HPV-FASTER-Implement will create a Europe-wide knowledge framework on vulnerabilities and the health challenges they pose, as well as the tools to monitor their evolution. HPV-FASTER-Implement will work with stakeholder representatives, primarily from vulnerable populations, to identify context-specific strategies to deliver combined HPV vaccines and HPV-based CC screening to eligible vulnerable populations, thereby reducing the burden of CC in Europe. HPV-FASTER-Implement will develop health education interventions, communication activities and other services to meet the need of vulnerable population with high risk of CC and inadequate access to health services. Through stakeholder engagement, health literacy promotion, mathematical modelling, implementation research, and vulnerability mapping, we will collect, analyse and share knowledge on gaps and opportunities to improve CC prevention in Europe, and progress FASTER towards CC elimination. We will work to ensure that the data we produce are translated into policy recommendations aimed at strengthening national prevention programmes with interventions tailored to vulnerable populations. In this way, we can leverage limited resources to rapidly reduce CC mortality. We aim to reduce health inequalities by offering an innovative prevention intervention to women at risk, with the hope that 50% of those offered the intervention will take it. HPV-FASTER-Implement will make the necessary improvements to European CC prevention policies.

Polycystic Ovary Syndrome (PCOS) is the most prevalent, chronic endocrine-metabolic disorder of adolescents and young women (AYAs), affecting 5-10% of AYAs worldwide. It is the most frequent cause of anovulatory subfertility. There is no approved therapy for PCOS. Standard off-label treatment with oral contraceptives reverts neither the underlying pathophysiology nor the associated co-morbidities Pilot studies have generated new insights into the pathophysiology of PCOS, and have thus led to the development of a new approach wherein the PCOS phenotype is reverted without side effects. The novel medication is a fixed, low-dose combination of two insulin sensitisers [Pioglitazone (Pio), Metformin (Met)] and one mixed anti-androgen and anti-mineralocorticoid (Spironolactone (Spi)] within a single tablet: SPIOMET SPIOMET4HEALTH will test, in a multicentre Phase II trial, the additive effects of each SPIOMET component, on top of lifestyle measures in AYAs with PCOS. SPIOMET aims at normalising the ovulation rate and endocrine-metabolic status via the reduction of hepato-visceral fat excess, in an early phase of the disorder. This approach is expected to reduce the risk of morbidity (including subsequent anovulatory subfertility), to improve the quality of life, and to lower the economic burden on European healthcare systems. The consortium clusters the experts from key research groups working on PCOS in AYAs, across Europe. The design of SPIOMET4HEALTH foresees that the patients themselves will be engaged over the entire timespan of the project, and will also contribute to the ultimate study evaluation. The update and validation of PCOS-specific Patient Reported Outcome Measures (PROM) will provide the first large-scale evidence on the psychosocial benefits of the tested treatments. The collective evidence from SPIOMET4HEALTH, once completed with economic modelling, will lead to conclusions that inform sound decision-making about PCOS across European healthcare systems.

Real-world evidence derived from real-world data (RWD) has a promising role to inform regulatory decision-making. Based on highly relevant use cases from regulatory practice and across the product lifecycle Real4Reg develops AI-based data-driven methods and tools for the assessment of medicinal products. Findings will inform training activities on good practice examples and will be implemented in existing and emerging guidelines for both health regulatory authorities and health technology assessment (HTA) bodies across Europe. There is urgent need to enable the use and establish the value of the application of RWD across the spectrum of regulatory use cases. The use of RWD is established in regulatory processes such as safety monitoring, but evidentiary value for further use cases, especially in the pre-authorisation and evaluation phase of medicinal products, is rudimentary. The use of RWD in post-authorisation steps is constrained by data variability and by challenges in analysing data from different settings and sources. Thus, the development of new and optimised methods for RWD analyses is essential. Real4Reg addresses the challenges and opportunities of RWD analyses across different health care systems by involving multiple stakeholders to work together in a collaborative approach, also outreaching to already established European initiatives. Our consortium assembles partners with outstanding excellence in the field of RWD analyses, including experts from regulatory agencies/ HTA (BfArM, DKMA, Infarmed), academia (Fraunhofer, UEF, CSC, AU, DZNE) and patient organisations (EUpALS, EIWH). In an advisory board stakeholders provide input and guidance to the project, including patients, industry, payers, HTA bodies and healthcare professionals. The structure and approach of our project facilitates the successful implementation of the effective use of RWD in regulatory decision-making and HTA, and ultimately supports the application of better medicines for patients.

Cervical cancer is the third most prevalent gynaecological cancer, after uterine body and ovarian cancers. Occurring in young women, with a peak of incidence around age 40 and death at 55 years, this cancer is one of the most marked by social inequalities. The women of the most disadvantaged social categories are those who combine both the most risk factors and poorer adherence to preventive measures that rely on vaccination against human papilloma viruses (HPV) and screening for early stage cervical lesions, starting at the age of 25 years. As almost every case of cervical cancer could be prevented by cervical screening and HPV vaccination. The different European countries have implemented cervical cancer screening practices, more or less systematic, and more or less effective, with rates of regular screening widely varying. Even in countries where this rate is high, such as Finland or Sweden, some women who are truly refractory to screening. This is a major health issue because these women are often at high-risk with a 5-year survival closely correlated with the stage of disease when discovered. The costs also increase exponentially depending on the cancer stage. Numerous randomized trials conducted around the world have attempted to improve the response rate in underscreened women. But unfortunately the response rate barely reaches 20% of these women. Many factors can explain the difficulties in obtaining a satisfactory screening rate, whether geographic distance, economic constraints, disengagement of general practitioners, education level or socioeconomic status. It is therefore a European public health problem for which we assembled a network of experts from 10 European countries (Belgium, Bulgaria, France, Germany, Ireland, Italy, Portugal, Romania, Spain, and Sweden), three research groups, the International Agency for Research on Cancer (IARC), the European Cervical Cancer Association (ECCA) and the Poverty Action Laboratory (J-PAL), and a representative association of patients, The European Institute of Women's Health (EIWH). These experts, clinicians and researchers, have expertise in screening for cancer, especially cervical cancers, in conducting large randomized clinical trials, in qualitative and quantitative analysis of social and cultural determinants, in analysis of social disparities and discrimination for access to care, or in modelling health policies. If all group members do not all have worked together in the past, numerous collaborations already took place within the group. The goal of our network is to file a research project for the H2020 SC1-PM-10-2017 call for proposal entitled “Comparing the effectiveness of existing healthcare interventions in the adult population.” This project aims to test, in partner countries, interventions to increase adherence to screening in underscreened women, with special attention, but not exclusively, to women of low socio-economic status; to evaluate the quality, and assess its drivers, of downstream management of abnormal screening findings; model interventions in different countries; to analyse the cost-effectiveness of the intervention; and finally to develop an implementation research to define the best strategy through European countries of different socioeconomic structures and disease prevalence levels. The project will be managed by a French coordinator and a steering committee of clinical researchers, and will be promoted and coordinated by the INSERM. The MRSEI funding will be used to strengthen interactions within the group, validate pillars of the program (work packages) and within these pillars refine more specifically questions deserving to be assessed.