New methods for the effective use of real-world data and/or synthetic data in regulatory decision-making and/or in health technology assessment

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Proposals should address all of the following areas:

  • Develop a set of evidentiary standards to be pre-specified and used in the analysis of real-word evidence and/or synthetic data applied to different types of regulatory advice and/or health technology assessment and decisions on the safety and efficacy/effectiveness of medicines and digital health innovations ( in complement to clinical trial data in an authorisation application, or for extension of indications, post marketing surveillance, amendment of product information or regulatory actions on the marketing authorisation due to safety concerns). This includes validating the use of advanced analytical methods for regulatory decision-making and/or health technology assessment.
  • Address aspects that would enable moving towards a standard data quality framework reproducible across different types of RWD and/or synthetic data sources for regulatory decision-making and/or health technology assessment, with a characterisation of the data collection, management and reporting and an empirical data quality validation. In this regard, it will be important that successful proposals liaise with and closely monitor the work carried out in the context of the European Health Data Space.
  • Enhance the performance and efficiency of large randomised clinical trials and new models of clinical trials by developing standardised processes and methods to access RWD and/or synthetic data (, facilitating the detection of various types of health outcomes during the treatment period of a double-blinded trial by linkage to appropriate electronic health care record databases, etc.), for regulatory decision-making and/or health technology assessment.
  • Define methodological standards for the regulatory acceptability of RWD, and/or synthetic data in the context of clinical trials augmented with RWD, and/or synthetic data, for regulatory decision making and/or health technology assessment.
  • Test the ability of machine learning methods to help identify relevant RWD, and/or synthetic data to match with and to interpret clinical trials, for regulatory decision‑making and/or health technology assessment.
  • Assess and validate how machine learning methods can be systematically harnessed to screen a large amount of data, including unstructured data, in many electronic databases to identify factors affecting efficacy and safety of treatments and/or digital health innovations, for regulatory decision-making and/or health technology assessment. The cross-border interoperability dimension should be taken into account.

 Soins de santé
 Développement et coopération
 Agenda numérique pour l'Europe
 Innovation & Recherche
 Horizon Europe
 Essais cliniques
 Intelligence artificielle

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