Background

On 23 February 2021, Alzheimer Europe published a report, "Data sharing in dementia research - the EU landscape", exploring the challenges of the data sharing in the field of dementia research.

Dementia currently affects almost 8 million people in Europe and is a leading cause of disability and dependency in old age. With the share of people aged 65 and over projected to rise to 29% of the European population by 2070, dementia is an increasingly critical public health issue. As such, research into the causes, diagnosis, prevention and care of dementia is of enormous importance – particularly as there are no disease-modifying treatments currently available.

In December 2013, at the G8 Dementia Summit, ministers agreed to share information and data from dementia research studies, to get the best return on investment in research. While numerous initiatives have been launched to make this promise a reality, data from many dementia research studies still remains siloed, stored behind the firewalls of research institutions, drug companies and medical centers. Since 2013, the European policy landscape has evolved substantially; the Horizon 2020 Framework Programme for Research and Innovation, initiated in 2014, is drawing to a close, and digital technologies and personalised medicine are now firmly on the EU agenda. The legal landscape has also been reshaped; for clinical research data to travel between institutions and across borders, researchers must now show compliance with the General Data Protection Regulation (GDPR).  

In this report, we outline the policy and legal landscapes that dementia researchers have had to navigate since the launch of Horizon 2020, identifying the key barriers and enablers for data sharing. We have also mapped the portfolio of projects on dementia funded by Horizon 2020, assessing the scale of EU investment in dementia research and the proportion of projects that involve the use of clinical research data. Finally, we reviewed recent surveys of researchers, research participants and patients, evaluating their perceptions, motivations and concerns regarding data sharing.

Key findings and recommendations

The key findings of the report include:

  • To date, EUR570 million has been invested by Horizon 2020 in 222 research projects on dementia and/or Alzheimer’s Disease. Of this, over EUR403 million was allocated to 65 multi-partner, multi-country consortium projects, 75% of which involve the use of clinical data - underlining the importance of systems that support secure data sharing between partners and across borders
  • EU Open Science policies have helped drive the development of data repositories, also embedding Open Access principles for publicly-funded research. However,concerns around intellectual property rights have prevented broad uptake of Open Science practices by the private sector; the implementation of FAIR practices also varies between member states
  • The GDPR has not yet fully delivered on its aim of facilitating safe data flows for research datasets.There are many unresolved issues that impede data sharing between partners and across borders, caused in part by a perceived lack of clarity and in part by the regulatory divergence that has been built into the GDPR
  • For patients and research participants,the benefit of data sharing comes with a privacy trade-off;loss of privacy is the most widely-reported concern for this group, which reduces their willingness to consent to data sharing
  • For researchers, the high value placed on publications and grants by academic reward systems means that many perceive a“reputation cost” to data sharing. This, along with the financial and time cost, as well as data protection concerns, decreases their motivation to share data.

The key recommendations of the report include:

  • To fully embed Open Science principles in practice, policymakers and other research stakeholders should work on co-creating a “shared research knowledge” system, with clearer policies and intellectual property frameworks as well as greater transparency and reciprocity between actors
  • To mitigate negative impacts of the GDPR on research data sharing, policymakers and legislators should develop pathways for faster, secure sharing of research data between sectors and across borders, including GDPR Codes of Conduct and tailored standard contract clauses for transfers beyond the EU
  • To address the perceived “reputation cost” of data sharing, policymakers, funders and research institutions should promote academic reward systems that place a greater value on data sharing, transparency and openness, incentivising the sharing of data by adopting measures that ensure data generators are credited when their data are reused 
  • To ensure datasets and platforms can continue to be used and shared, funders and research institutions should provide support to maintain and sustain these valuable resources when their research funding period ends
  • To increase awareness and trust in data use, reuse and sharing, policymakers at EU and member state level should take concerted actions to increase data and digital literacy, ensuring that older adults and vulnerable groups are not left behind
  • To help ensure that decisions on research data sharing are relevant, transparent and ethically sound, researchers should involve people with dementia in the design and conduct of research, and in data governance; this is also a valuable step towards increasing trust.

Beyond these and other measures to facilitate data sharing, there is a need for increased investment in dementia research. People with dementia have also been disproportionately affected by the COVID-19 pandemic; as well as being at higher risk of mortality and morbidity, many have experienced a worsening of symptoms due to social isolation and lack of access to care. Despite this, due to the tightening of EU research budgets, there is a significant risk of dementia research being deprioritised, threatening its future viability and long-term sustainability. The EU and its member state governments must ensure that there is continued investment in dementia research, so that the gains from research – and data sharing - are not lost.

The full report can be downloaded below.