What's the problem?
Medical researchers and healthcare systems generate vast amounts of data every single day. If linked up and harnessed, it could revolutionise medicines development and healthcare. However, most of this ‘big data’ remains in silos, inaccessible to most researchers, its potential untapped. Meanwhile digital technologies and wearable devices offer new and more efficient ways of gathering data, but question marks remain about how to address issues like patient privacy and how these devices fit in with patients’ lives.
What is IMI doing about it?
IMI has had ‘big data’ projects since its creation. Project outputs include the EHR4CR project’s platform that enables controlled access to hospitals’ data for the preparation of clinical trials. The platform has demonstrated its usefulness in speeding up the recruitment of patients, while ensuring that patient privacy is respected. The Open PHACTS Discovery Platform links up existing data sources and allows scientists to rapidly answer complex questions in drug development. And the EMIF project used existing data to generate new insights into Alzheimer’s disease. Today, IMI’s Big Data for Better Outcomes programme is addressing the technical, legal and ethical issues that currently prevent researchers from making full use of the data that is out there. What’s more, the projects are putting ‘big data’ principles into practice to advance research in the fields of cardiovascular disease, haematological malignancies (blood cancers), Alzheimer’s disease, and prostate cancer. IMI also boasts a number of projects working on health-related mobile and digital technologies.
IMI organised an event on IMI impact on data. You can view the recording and presentations here.
IMI projects moving the needle
Our research is...
...cutting down on the time it takes to carry out clinical trials
EHR4CR's software helps clinical trial managers make sure they can recruit enough patients for their studies, while Pharmaledger matches the right patients to the right trials. EU-PEARL is testing out trials that share a control group while testing multiple drugs from different companies at the same time, and Trials@Home is piloting trials that run remotely, making it easier on participants and generating more and better data.
|… showing how real-world electronic data records can be used to make quick, evidence-based decisions||
It can take months or even years to gather evidence needed to make decisions in healthcare. EMIF has created a data catalogue of electronic databases containing real-world data records about different diseases, and made it available to researchers. EHDEN has linked up a (growing) network of real-world data sources to help answer research questions quickly, while GetReal focuses on making it easier for decision-makers - like payers and policy makers - to use real-world data to make better choices about new innovations.
|...finding out what aspect of their condition patients care most about||
Clinical research needs to address the needs of patients. HARMONY are analysing anonymised patient data from different sources to find out about patients’ priority outcomes. PIONEER is carrying out the same big data analysis to make interventions more efficient and patient-centred in men diagnosed with prostate cancer, while BigData@Heart’s real-world data-driven research platform is providing insights that are helping usher in treatments tailored to individual patients.
|…using personal devices, apps and motion sensors to bring clinical trials home||
Smartphones and wearable devices like smart watches can help really understand how patients experience their conditions in their everyday lives. RADAR-CNS is studying whether they can be as an early warning of relapses of depression, MS and epilepsy, while RADAR-AD is using devices and apps to measure mobility in people with Alzheimer’s, and IDEA-FAST is focusing on sleep disturbances. Mobilise-D is building a system that can monitor and evaluate people’s gait in various diseases including Parkinson’s and congestive heart failure.
Accelerating clinical trials will ensure the latest innovations can reach the patients in a timely manner
The EHR4CR project successfully developed software to allow clinical trial sponsors to better plan their trials by ensuring the clinical trial designs will be able to recruit sufficient patients for their needs. The resulting platform has continuously expanded and is now part of a global network (TriNetX).
PharmaLedger aims to facilitate the easy matching of patients to suitable clinical trials, while maintaining patient privacy. It is also working on a trusted system to allow Internet of Things devices (wearables, home monitors etc…) to be easily used in clinical research.
EU-PEARL is developing a framework to run multi-company ‘platform’ trials that could test many potential medicines at once. By also using a single control group, the project should result in speedier access to more effective and personalised treatments.
Trials@Home’s objectives are to run clinical trials completely remotely. Instead of a patient having to regularly visit a centralised facility, the study would fit around the patients life, eg monitoring at home, work or wherever is most convenient, thereby facilitating more patient participation leading to more robust study outcomes.
While gathering sufficient evidence for healthcare decision making can take months, or even years, the COVID-19 pandemic has shown that immediate, reliable answers can be crucial.
EMIF laid the foundation for a number of subsequent IMI projects through facilitating access to Real World Data (RWD) at scale to answer research questions in Alzheimer’s Disease and Obesity.
A key output is the EMIF data catalogue which includes details of many datasets.
The EHDEN project has put in place a network of real-world data sources which can be mobilised in a short time-frame to provide rapid answers. This Europe-wide network is still growing, and has already produced important insights into the safety of potential COVID-19 treatments.
Get Real focusses on using Real World Data to address the needs of downstream health care decision-makers, in particular, health technology assessment agencies.
To ensure the results of clinical research address the needs of the patients, it is crucial to have defined ‘outcomes’ that matter to patients, and can be measured in clinical trials. A number of IMI projects are working defining outcomes, and gathering data so they can be measured.
The key outstanding questions in cancers that affect the blood and lymphatic system can only be answered by studying large numbers of patients. HARMONY has assembled the largest dataset in Europe and is applying big data technologies to improve the treatment of these cancers.
PIONEER is combining and analysing the patient records of men diagnosed with prostate cancer to provide more efficient outcome-driven patient-centred interventions.
BigData@Heart is developing a real world data-driven research platform of unparalleled scale to deliver clinically relevant disease insights driving drug development and personalised medicine through advanced analytics.
Novel technologies, such as smartphones and wearables, offer an exciting opportunity to really understand how patients experience their conditions in their everyday lives. Several IMI projects are working on harnessing the power of these devices to improve healthcare.
RADAR-CNS is studying whether data from smartphones, wearables and mobile apps can be used to give an early warning of relapses of depression, MS and epilepsy. Their RADAR-base data collection platform is also being used for many other studies.
RADAR-AD is exploring how mobile technologies – such as smart phones, wearables and home-based sensors – can be used to measure disability progression associated with Alzheimer’s Disease.
IDEA-FAST is using new technologies to identify novel digital measures for fatigue and sleep disturbances that will provide more objective, sensitive and reliable measures of the severity and impact of these symptoms in the person’s normal surrounding.
Mobilise-D is developing a comprehensive system to monitor and evaluate people’s gait based on digital technologies, including sensors worn on the body. The project focuses on conditions which often affect mobility, namely chronic obstructive pulmonary disease, Parkinson’s disease, multiple sclerosis, hip fracture recovery, and congestive heart failure.
Launched in 2016 by project partner, Custodix, InSite enables scientists to find suitable candidates for trials by searching millions of EHRs stored in hospitals and clinical data warehouses throughout Europe, while maintaining patient privacy.
EHDEN has dramatically demonstrated the power of using clinical data in research by replicating, during a five-day ‘study-a-thon’, the results of a systematic review covering 20 years of research, and a multi-year clinical trial.
Can real world data replicate a clinical trial? EHDEN study suggests yes
HARMONY uses big data to gather , integrate and analyse anonymous patient data from a number of high-quality sources in order to define clinical endpoints and outcomes for blood cancer patients.
Harmony Alliance provides novel insights into acute myeloid leukemia
Thanks to WEB-RADR, a smartphone app is being used internationally for reporting side effects of medicines.
MELLODDY have shown that ‘federated learning’ can be used to pool datasets from multiple pharma companies without revealing any valuable secrets.