What challenge is ROADMAP facing?
In the context of demographic change, Europe is facing an acute healthcare challenge. In no area is this more apparent than in Alzheimer’s disease (AD) and dementia. AD and related dementias affect nearly 50 million individuals worldwide with prevalence projected to double over the next twenty years. So far there is no cure for AD and challenges in the evaluation of early disease interventions within the current assessment systems have not changed. Consequently, the precision medicine approach to health funding requires new models that encompass all the available evidence for the identification of best suited treatments for different groups within the AD continuum.   Read more about the state of precision medicine in AD
What is dementia?
“Dementia” is a syndrome (i.e. a pattern of symptoms) and typically involves loss of memory, mood changes and problems with thinking, orientation, comprehension, calculation, learning capacity, language and judgement. It is the umbrella term used to describe the symptoms that occur when the brain is damaged as a result of one or more diseases or conditions, resulting in memory and intellectual impairments which are sufficiently severe as to interfere with daily life. Read more about the prevalence of dementia in Europe
What is Alzheimer's disease (AD)?
AD (the most common cause of dementia) is a progressive disease characterised by loss of function and death of nerve cells in several areas of the brain. The neurodegeneration leads to loss of cognitive functions such as memory and learning. The new Alzheimer’s Diagnostic Guidelines refer to the spectrum of AD in three stages; (1) preclinical AD, (2) mild cognitive impairment (MCI) due to AD, and (3) dementia due to AD.

Read more about the changing definition of AD
What is real-world evidence (RWE)?
Real-world evidence (RWE) is derived out of real-world data (RWD) by the analysation of this kind of data. RWD is a broad concept, which depends on differing conceptualisations across its research paradigm. In the realm of ROADMAP, we have a definition of data which are coming from structured data sources, and are organised in a pyramid of evidence. These include large broad population-based databases, for example from Nordic countries, the Netherlands and UK. These are national registries and health care registries, together with available electronic medical records, data from general practitioners (GP’s) covering what is documented during daily care of patients when they are visiting the GP’s. We also have dedicated cohort data which are rich in disease-specific information, these are coming from research on patients that have dementia or AD. Last but not least, there are also data from clinical trials which one might not see as RWE, but are complementing as evidence.

  Read more:

What Is Real-World Data? A Review of Definitions Based on Literature and Stakeholder Interviews

Practical Implications of Using Real-World Evidence in Comparative Effectiveness Research
What is an Outcome?

An outcome means any result that a treatment can have. An outcome can be an improvement in a person’s health, but non-health outcomes also exist. For example, care giver burden, the ability to perform work or daily activities, or hospital episodes are all possible outcomes. We also consider costs as relevant outcomes, and consider healthcare costs (which are costs of treatment, drugs, etc) and non-healthcare costs (for example, not being able to work due to an illness).

What is data pooling?
Data pooling is a process where data sets coming from different sources are combined. This can mean two things. First, that multiple datasets containing information on many patients from different countries or from different institutions is merged into one data file. Second, that data on one patient, coming from multiple sources such as e.g. primary care, specialist clinics and insurance company are combined together. In both cases pooling results in a fuller and more useful data set for scientific research. Are you interested in European neurodegeneration research? Visit our support and coordination action:
Big Data for Better Outcomes

    Healthcare systems in Europe are facing a number of challenges that need to address how to:
  • Demonstrate more evidence-based value in an increasingly price-constrained environment.

  • Improve a health data collection landscape marked by a group of systems that is often duplicative, uncoordinated and inefficient.

  • Engage patients to become more active data owners and contributors – whilst ensuring privacy.

Enter ‘Big Data’, which has the potential to contribute significantly to meeting all these challenges and which also gave rise to the Big Data For Better Outcomes Programme (BD4BO).  Its mission is to improve health outcomes and healthcare systems in Europe by maximising the potential of Big Data.

ROADMAP is a partner in this ambitious project, which is part of the Innovative Medicines Initiative (IMI) 2 – the world’s largest public-private partnership in the life sciences.  The scope of BD4BO currently consists of four disease-specific projects that are focusing on Alzheimer’s disease; Haematologic malignancies; Cardiovascular diseases; and Prostate cancer. There are also two co-coordinating projects – one that serves all BD4BO projects, and the European Health Data Network (EHDN) – an infrastructure project whose objective is to establish a federated network of relevant and high-quality data sources across Europe.

Big Data has the potential to be truly transformational. There is a collective understanding amongst all the key stakeholders that we need to collaborate better to harness the power of Real-World Data. The benefits to society span a broad spectrum of sectors including healthcare systems, disease treatment, trial/product design and use, and most importantly, patient use of our medicines.

For more information, go to the BD4BO website.

Harnessing the power of Big Data has the potential to transform healthcare systems and patient outcomes