Abstract 917P
Background
OPTIMA (Optimal Treatment for Patients with Solid Tumours in Europe Through Artificial intelligence) is an Innovative Medicines Initiative (IMI) 2 funded public-private research programme that seeks to use artificial intelligence (AI) to improve patients’ care with prostate, breast, and lung cancer. OPTIMA’s goal is to design, develop and deliver the first interoperable, GDPR-compliant real-world data (RWD) and guideline-driven evidence-generation platform in Europe.
Methods
OPTIMA’s multidisciplinary consortium is focused on: 1. Establishing a secure, large-scale evidence, GDPR-compliant data platform that includes RWD from >200 million people. The interoperable platform will host datasets, data analysis tools, federated learning tools and AI algorithms; 2. Developing clinical decision support toolsets based on national and international treatment guidelines underpinned by evidence from advanced AI models to better support medical decision making; and 3. Using big RWD to drive knowledge generation, especially where current existing evidence underpinning clinical guidelines is weak or not covered.
Results
Our multidisciplinary pan-European consortium consists of 36 partners from across 13 countries in the clinical, academic, patient, regulatory, data sciences, legal, ethical, and pharmaceutical fields. It has been granted €21.3 million in IMI funding, an effective project management model, Scientific Governance Board and 3 independent advisory boards are in place: Multistakeholder; Ethical/Legal; and Public/Private, to provide timely, unbiased, expert advice. OPTIMA has secured access to EHR and registries covering several million data sets across Europe, with a strategy to further expand. The consortium will also develop both a central and federated data sharing model for data contributors.
Conclusions
OPTIMA is a unique multidisciplinary public-private partnership to develop guideline-driven healthcare evidence-generation practices for the incorporation of RWD into clinical practice. The tools and models developed strive to process high-dimensional data to identify factors that support individualised care decisions for oncologic patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Pfizer Pharma GmbH.
Funding
OPTIMA is funded through the IMI2 Joint Undertaking and is listed under grant agreement No. 101034347. IMI2 receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA). IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe.
Disclosure
A. Cannon: Financial Interests, Personal and Institutional, Full or part-time Employment: Genentech, Inc., F. Hoffmann - La Roche Ltd. S. Auweter: Financial Interests, Personal and Institutional, Full or part-time Employment: Smart Reporting GmbH. M. Thomas: Financial Interests, Personal and Institutional, Full or part-time Employment: F. Hoffmann - La Roche Ltd. A. Kremer: Financial Interests, Personal and Institutional, Full or part-time Employment: ITTM. D. Dellamonica: Financial Interests, Personal and Institutional, Full or part-time Employment: AstraZeneca AG. D.P. Alhambra: Financial Interests, Institutional, Funding: European Medicines Agency, Innovative Medicines Initiative, Amgen, Chiesi, UCB Biopharma; Financial Interests, Personal and Institutional, Invited Speaker: Astellas, Amgen, AstraZeneca, UCB Biopharma. A. Asiimwe: Financial Interests, Personal and Institutional, Full or part-time Employment: Bayer AG. X. Ji: Financial Interests, Personal and Institutional, Full or part-time Employment: Pfizer Inc. P. Torremante: Financial Interests, Personal and Institutional, Full or part-time Employment: ARTTIC Innovation GmbH. S. Keller: Financial Interests, Institutional, Full or part-time Employment: Pfizer. F. Kube: Financial Interests, Personal and Institutional, Full or part-time Employment: Pfizer Pharma GmbH. H. Krueger: Financial Interests, Personal and Institutional, Full or part-time Employment: Pfizer Pharma GmbH. All other authors have declared no conflicts of interest.