For patients with chronic diseases such as neurodegenerative disorders (NDD) and immune-mediated inflammatory diseases (IMID), a key attribute for any successful therapeutic intervention is its ability to improve the patients’ activities of daily living (ADL) and health-related quality of life (HRQoL). Current evaluations of ADL and HRQoL rely mainly on subjective reports, typically using standardized questionnaires provided by patients every few months. The approach is often prone to recall bias, reliability issues and poor sensitivity to change. IDEA-FAST wants to change this!

The goal is to identify, profile and validate digital solutions based on mobile or residential technology for remote assessment of fatigue and sleep disturbances that could effectively be used as digital endpoints in assessments for RA, SLE, PSS, IBD, PD, HD and beyond. Identifying digital endpoints for fatigue and sleep disturbances that can be used in patients’ usual living environment will also enable the meaningful evaluation of impacts of these symptoms on ADL/HRQoL. The ecological validity of these digital endpoints will be tested using a large longitudinal cohort of four IMID and two NDD.

Patient groups

KEY CHALLENGES
OBJECTIVES
VISION
CONTEXT
MISSION
UNICOM ACTION LINES
ESTABLISHING A SEAMLESS IDMP DATA VALUE CHAIN
KEY CHALLENGES
Most resource-rich countries maintain at least basic national (electronic) repositories and data bases of medicinal products which have gone through the stipulated regulatory national process to be marketed in that national healthcare system. Unfortunately, these uncoordinated national regulatory procedures have resulted in a host of unintended results and impacts endangering patient safety and hindering better healthcare service delivery, particularly in international contexts:
OBJECTIVES

UNICOM supports

  • regulatory processes of National Medicinal Products Authorities (NCAs) & the European Medicines Agency (EMA)
  • global pharmacovigilance
  • advancing cross-border digital health, particularly ePrescription, services
  • better healthcare, public health, medical research (e.g. Big Data analytics, AI applications)

Core objectives focus on:

  • Adaptation and implementation of IDMP at EU and NCA level
  • Adaptation of Member States cross-border digital health services (ePrescription; Patient Summary…) to IDMP
  • Exploration and implementation of IDMP for pharmacovigilance reporting, Medicinal Product Dictionaries (MPDs), digital healthcare support services, patient empowerment
VISION

UNICOM is dedicated to

  • improving patient safety globally
  • facilitating better healthcare for all
CONTEXT
The univocal identification of medicinal products is a global challenge. By going it alone, countries hinder the free flow of detailed, interoperable medicine information in the European Union, across the Atlantic, and globally. The UNICOM project joins forces with other stakeholders in our health systems to spearhead solving this challenge. It will accelerate the further diffusion of ISO IDMP standards (Identification of Medicinal and pharmaceutical Products).
MISSION

UNICOM supports and enables the univocal identification of medicinal and pharmaceutical products by facilitating and accelerating the

  •  further development,
  •  implementation, and
  •  diffusion of ISO IDMP standards (IDentification of Medicinal and pharmaceutical Products)

across European health systems.

UNICOM ACTION LINES

To achieve the objectives envisaged and reach the outcomes foreseen, UNICOM is organised along three closely interrelated vertical action lines:

  • Implementation of IDMP  at EU /National MPs data base level
  • Adaptation of cross-border digital health services
  • Exploration for pharmacovigilance services, Medicinal Product Dictionaries [MPDs], healthcare services, patient empowerment, Big Data etc.

These three action lines are supported by two horizontal activity clusters:

  • Further development of IDMP standards and implementation support
  • Socio-economic impact assessment and sustainability strategies, scientific coordination, project management, awareness raising and dissemination.
ESTABLISHING A SEAMLESS IDMP DATA VALUE CHAIN
UNICOM will help to break down barriers hindering the free flow of detailed, semantically coded interoperable drug information across the globe.

Goals

  • Identify and select a set of digital endpoints and corresponding digital devices/technologies
  • Build a digital management platform
  • Establish a large and well-characterised longitudinal cohort of  patients
  • Run a (1) feasibility and (2) clinical validation study
  • Receive scientific advice from EMA for the future use of digital endpoints in clinical trials

Impact

  • Novel clinically validated digital endpoints for fatigue, sleep disturbances and other ADL/HRQoL
  • More valid and complete assessment of the impact of diseases and treatments
  • Reduced patient burden, improved patient centred and personalised care
  • Better clinical management
  • Deeper insight into disease impact and afflictions
  • Larger and more inclusive clinical trials, faster clinical development of new therapies
  • Lasting impact through high quality data set on fatigue and sleep disturbances
  • The development and clinical validation of IDEA-FAST digital endpoints, together with the associated integrated digital and clinical data set, will put Europe at the forefront of this field and enable the growth of a significant new worldwide market sector