Prostate Cancer (PCa) is the second leading cause of cancer, among men in Europe. There are currently major unmet needs in this field, such as insufficient knowledge on risk factors that contribute to PCa and on patient characteristics (including genetic profiles) that could facilitate patient stratification. Finally, there is lack of meaningful engagement of all key stakeholders, while the knowledge currently gained from clinical practice and real life data is not being fed back into PCa patients’ care pathways. There is thus a need for better definition of PCa across all stages, improved patient’s stratification at diagnosis, and standardisation of PCa-related outcomes based on real life data. PIONEER’s unique dual approach is to first identify critical evidence gaps in PCa by respected Key Opinion Leaders, and then embark on a research priority setting exercise that reflects the needs of all key stakeholders in PCa management. To achieve this, PIONEER has brought together comprehensive datasets that consists of the most relevant prostate clinical trials and registries, large epidemiological cohorts, electronic heath records, and real-life data from different European (and non-European) patient populations. These unique data sets will be integrated, standardised, harmonised and analysed using approaches that are built on our experience of similar previous IMI projects i.e EMIF, and eTRIKS, and analysed using a unique set of methodologies and advanced analytics methods (OMOP, eHS). PIONEER has already performed a first PCa research priority setting survey, where major stakeholders were asked to identify the current unmet needs in PCa. The five most important open questions will be used as pilot studies to verify PIONEER’s research framework. As such, PIONEER’s deliverables will be outcome-driven, value-based and patient-centric, and relevant to all key stakeholders, as they would have been meaningfully involved from the inception of the project.

OPTIMA is a multi-stakeholder-led consortium with the vision that each and every patient should have access to the most up-to-date individualised treatments and to innovative therapies. In that perspective, we will design, develop and deliver the first interoperable and GDPR compliant European real-world oncology data and evidence generation platform, along with decision support toolsets for prostate, lung and breast cancer. By designing this platform from the onset based on the needs of the clinicians and patients in an inclusive and sustainable way, OPTIMA aims to strengthen shared decision-making based on innovative data and AI-driven technology and tools. To achieve our vision, we have united the key partners from other data-driven European wide oncology initiatives (PIONEER, EHDEN, HARMONY) in our project along with Europes leading clinicians in the fields of breast, prostate and lung cancer that all have leading roles in medical societies such as ERS, ESMO, and EAU. At the core of the OPTIMA project are the major guideline offices of the three indications, whilst the project is further strengthened by patient advocacy groups, well-known academic partners and 6 SMEs as partners covering the needed expertise to implement OPTIMA successfully. The platform will build on existing open source solutions such as the OMOP-CDM, tranSMART and OHDSI ATLAS whilst developing novel AI models based on federated learning to facilitate knowledge discovery. At the start of the project, we will already have access to datasets covering over 200M people in Europe, along with data from high quality patient cohorts for AI model building. Moreover, the platform will be hosted in-kind on existing infrastructure provided by Helmholtz Institute in Germany. Finally, OPTIMA envisions sustainability of its platform through a value-based approach with various business models for commercial users.