- What's IMI's impact on patient involvement in research? Sign up for our impact event and find out
- Results roundup: 13 years of diabetes breakthroughs
- UNITE4TB project aims to boost trials of new TB treatment regimens
- New project Inno4Vac targets faster vaccine development
- PROTECT-trial project to study the use of proton therapy in oesophageal cancer
- Results build trust: how to create a pan-EU health data space
- To quarantine or not to quarantine? Predictive models can guide doctors’ judgement
- Identification of patient subgroups could pave way for personalised Sjögren’s syndrome treatments
- Wearable can predict risk of fatal epilepsy complication
- Clinical trials without the clinic. What have we learned so far?
- PREFER probes patients’ preferences for gene therapy in haemophilia
- Blockchain could help put people at ease about sharing their data
- A new way of studying an old question – which medicines can be taken safely while breastfeeding?
- First direct evidence of the influence of food on skin bacteria
- Clinical trials for infectious disease research, on demand
- New non-profit organisation to help usher in EU’s networked and harmonised health data space
What's IMI's impact on patient involvement in research? Sign up for our impact event and find out
Registration is now open for an online event on IMI's impact on patient involvement in research on Thursday 7 October at 14:00 CEST (Central European Summer Time / Brussels time).
Today, it is widely recognised that patients can and should be much more closely involved in all aspects of research. At IMI, we seek to encourage patient involvement in all our activities, and many projects already have patients on board. We also involve patients as speakers and panellists in our events and encourage their participation in consultations.
This event is part of a series of live sessions that IMI is organising on the impact of IMI in key areas. This session will showcase the impact of IMI in the field of patient involvement and will also explore the different challenges and benefits of collaborating with patients and carers by using concrete examples from IMI projects.
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- Register to attend the webinar
- Find out more about IMI's impact on patient involvement in research
Results roundup: 13 years of diabetes breakthroughs
IMI has launched 13 projects and spent almost EUR 450 million on diabetes research. Now an analysis by a trio of scientists from the University of Lisbon has illuminated just how big the impact of this effort has been when taken all together.
Writing in the journal Frontiers, the team examines how IMI projeect results fit with IMI and Europe’s strategic research goals, namely new targets and biomarkers, better clinical trials, new and better medicines, and patient-tailored adherence programmes.
Among other things, IMI projects have shown that there are distinct subgroups of type 2 diabetes; identified signs of looming blood sugar problems; and worked on tools to predict how well a person will respond to certain drugs. In other developments, the first ever human pancreatic beta-cell line that can be studied in the lab is now being used by the scientific community. Another team built the infrastructure for clinical trials of diabetes drugs, including more efficient 'adaptive' trials.
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UNITE4TB project aims to boost trials of new TB treatment regimens
Tuberculosis (TB) kills around 1.5 million people annually, making it one of the leading causes of death worldwide. Treatment consists of a combination of drugs taken for at least six months, and drug resistance is on the rise. Identifying new treatments and treatment combinations that could shorten the treatment time and tackle drug resistance is difficult and time-consuming.
Now IMI has launched a new project, UNITE4TB, which aims to accelerate and improve clinical trials of combinations of existing and new drugs, with the goal of developing new and highly active treatment regimens for TB, including drug-resistant TB.
Between them, the partners have access to the majority of the most innovative anti-TB drugs that are at an advanced stage of development. The project will focus on phase 2 clinical trials, in which drugs are tested in patients with a view to gathering data on the drugs’ safety and efficacy as well as the best dosage and delivery method (e.g. tablet or injection).
UNITE4TB will run for 7 years and has a total budget of EUR 185 million. The project is part of IMI’s AMR Accelerator programme.
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New project Inno4Vac targets faster vaccine development
Vaccines are a huge public health achievement, saving an estimated 2.5 million lives every year and protecting millions more from illness and disability. However, developing new vaccines is extremely time consuming, costly and risky.
New IMI project Inno4Vac aims to harness advances in fields such as immunology, big data and artificial intelligence, and incorporate them into the vaccine industry. The 6 year project brings together experts in clinical research, immunology, microbiology, systems biology, mathematical models, and regulatory issues.
This diverse team will focus on developing both in silico (i.e. computer-based) and lab-based tools. Throughout the project, the partners will develop strategies and roadmaps to ensure that their models meet the needs of medicines regulators and integrate them into vaccine development processes. Ultimately, the models developed by the project should help to make vaccine development both faster and more efficient.
Inno4Vac has a total budget of EUR 38.5 million.
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PROTECT-trial project to study the use of proton therapy in oesophageal cancer
Radiotherapy plays a key role in the treatment of many cancers. However, it does have some drawbacks. Proton therapy is an innovative form of radiotherapy. As the treatment is more focused on the tumour itself, a higher dose can be delivered while limiting damage to other, healthy organs, leading to shorter treatment for patients, and hopefully, better outcomes.
The aim of the new IMI project PROTECT-trial is to compare the results of proton therapy and radiotherapy for people with cancer of the oesophagus whose treatment also includes chemotherapy and surgery. The team will do this by carrying out a clinical trial involving 400 patients in 9 countries. If the results of the trial come out in favour of proton therapy, it could become a standard treatment option for patients with cancer of the oesophagus.
The hope is that with proton therapy, patients will recover faster and experience fewer side effects, dramatically improving their quality of life. Although PROTECT-trial focuses on cancer of the oesophagus, the results will have implications for many other cancers.
The partnership behind the PROTECT-trial project engages 12 proton therapy centres, 17 academic partners, two leading industry partners and more than 30 clinical trial sites from eight countries, with a total funding pot of EUR 4 763 734.
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Results build trust: how to create a pan-EU health data space
Experts from IMI’s Big Data for Better Outcomes (BD4BO) programme have some recommendations on how to make the European Health Data Space really work for patients, doctors and researchers.
The BD4BO programme was set up to explore new, improved and ethical ways for researchers to unleash the collective power of healthcare datasets, with the ultimate aim of improving real-life outcomes for patients.
In response to the European Commissions’ announcement of their intention to put in place a European Health Data Space (EHDS), experts from BD4BO have offered up the following recommendations based on their extensive experience working out the right tools and rules for harnessing and exploiting big data via a multi-themed portfolio of research projects.
- Showing results can build trust
- Use what already exists
- Getting everyone on board will require big investments
- Ensure an interoperable and flexible architecture
- Meaningful codes of conduct will strengthen citizens’ rights
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- Read the article in full
- Read the recommendations
To quarantine or not to quarantine? Predictive models can guide doctors’ judgement
Around the world, doctors are using artificial intelligence to help them make decisions about patient care during the COVID crisis. Feeding on clinical, laboratory, genetic, and radiological datasets, machine learning models are able to churn out predictions that can be used to identify, for example, who ought to self-quarantine, and who ought to make their way to the hospital.
With more and more of these models popping up around the globe, the DRAGON project set out to create an online platform that would serve as an open source repository for a curated subset, with a simple interface that allows users to make online calculations. The website can be used by doctors to supplement their judgment with patient-specific predictions from externally validated models in a user-friendly format.
DRAGON sought out publicly available, validated, peer reviewed or open-source models and published them alongside supporting documentation and links to associated articles. The platform is dynamic and growing; it currently features nine models, and will continue to be populated with others as they become available. It is hoped that the platform will help speed up the adoption of predictive models, moving them from the research world into clinical practice.
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Identification of patient subgroups could pave way for personalised Sjögren’s syndrome treatments
There is currently no treatment for primary Sjögren’s syndrome (pSS), an autoimmune disease that can affect a range of organs and tissues. New findings from IMI’s PRECISESADS project could help to change that.
In recent years, scientists have run clinical trials of a number of treatments for pSS, but none of these proved successful, and to date there is no approved treatment for pSS. One reason for the clinical trial failures could be the diversity of pSS patients; some treatments may work for certain sub-groups of patients – the challenge is to identify these subgroups and match them up with appropriate treatments.
Now, a new paper in Nature Communications suggests that there could be four sub-groups of pSS patients. The team arrived at this conclusion after drawing up detailed molecular profiles from blood samples from over 300 pSS patients and comparing these with profiles from 330 healthy volunteers. The team also offer suggestions as to which kinds of treatments could work best for the different subgroups, effectively paving the way for more personalised treatments for pSS.
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Wearable can predict risk of fatal epilepsy complication
Scientists from IMI’s RADAR-CNS project have been awarded the Harald Frey prize for their work on the use of wearables to gauge the likelihood of sudden unexpected death in epilepsy (SUDEP). The prize recognises the best scientific research on causes of SUDEP, as well as prevention methods and coping strategies.
Wearable sensors can be used to detect seizures in people with epilepsy. The RADAR-CNS team suspected that they could also be used to detect not only the seizure itself, but also to measure post-ictal immobility, or the absence of motion following a seizure, a warning sign that the person is at increased risk of a complication that can cause SUDEP.
The researchers fitted accelerometers, which measure sudden motion, on people presenting with convulsive seizures at a hospital epilepsy monitoring unit. Of 22 seizures, 20 were followed by post-ictal immobility while two were followed by agitation. The results from the wearable’s algorithm matched that of experts who watched video recordings of the patients. The study, published in Epilepsia, showed that wearables could offer hope as a continuous, non-invasive, long-term way to identify risk factors associated with seizures, with potentially great clinical importance.
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Clinical trials without the clinic. What have we learned so far?
New technology – and COVID – have caused an uptick in the use of remote decentralised clinical trials (RDCTs), in which digital and other innovations shift activities that usually take place at a hospital or clinic to a participant's home or other more local setting. IMI project Trials@home interviewed 48 people involved in RDCTs, to find out what works, and what doesn’t.
The general conclusion is that some things, like recruitment, are made easier by remote trials. One woman participating in a fully remote trial explained how she appreciated how easy it was to fit into her routine. Gathering data from multiple sources can also contribute to data completeness. However, many interviewees on the trial management side mentioned that it can be a challenge to keep participants engaged in trial activities. Other concerns raised include the question of whether RDCTs may transfer the work onto participants and remote staff, while technology does not always function as anticipated.
‘RDCTs will continue to face challenges in implementing novel technologies,’ the authors conclude. ‘However, maximising patient and partner involvement, reducing participant and staff burden, and simplifying how participants and staff interact with the RDCT may facilitate their implementation.’
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PREFER probes patients’ preferences for gene therapy in haemophilia
For innovative treatments and treatments for rare diseases, finding a way to include the patient perspective in decision-making can be crucial. With answers from 117 people with haemophilia, PREFER researchers present their results from their clinical case study about haemophilia patients’ preferences for gene therapy. They found that patient preferences vary greatly. And that informing patients about gene therapy can facilitate acceptance.
The results from this clinical case study showed the importance of patient education on gene therapy, as the researchers included an educational tool on gene therapy at the start of their survey and the time that patients spent on this tool was found to have an impact on the results. The patients who took more time to take in the educational materials offered, tended to be more accepting of gene therapies. For innovative treatments, educational tools may be especially useful to collect the informed views of patients. This to make sure they have the information they need to make informed trade-offs between the different benefits and risks of current treatment options and gene therapy.
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Blockchain could help put people at ease about sharing their data
Throughout the pandemic, COVID19 contract tracing apps have popped up all over the world. In a recent article, ROMSOFT, a partner in the Pharmaledger project that creates custom R&D software, used the project’s personal health data use case as a good example of how privacy concerns related to systems like tracing apps might be overcome, alongside artificial intelligence and machine learning.
PharmaLedger proposes a protocol called Open DSU, or open data sharing unit. This is a unit of data that is located off the chain, encrypted and only then directly anchored in the blockchains. This means that patients are in control of their confidential data via a digital wallet on their smartphones. Instead of managing your money, you manage the keys to your private data.
‘With a platform like PharmaLedger, any consumer app that will be built on top of it will follow the governance rules of the PharmaLedger platform, including the way data privacy is enforced,’ the article reads. ‘Enabling this type of ownership and providing information that is relevant, correct and easy to understand is essential in managing fear and increasing trust in data sharing.’
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A new way of studying an old question – which medicines can be taken safely while breastfeeding?
Studies of medicines safety and breastfeeding often involve animals. Now IMI’s CONCEPTION project has a plan that could deliver better results while also using fewer animals.
One of the aims of the CONCEPTION project is to deliver knowledge, tools and resources so that breastfeeding women and their doctors can take an informed decision about whether or not it is safe to breastfeed while taking a given medication. As part of this effort, the project is collecting samples of milk from breastfeeding women. However, on its own, this is not enough, and so the project is investigating other ways of studying which medicines are likely to make it into breast milk.
Currently, three types of models are used to help answer this question. In vitro models consist of cells in a dish or test tube, while in silico models are computer based. CONCEPTION is working to improve in vitro and in silico models. Finally, there are animal (in vivo) models, which are useful for analysing the mechanics of how a medicine makes it into the breast milk. CONCEPTION researchers recently published an extensive review of the pros and cons of different animals as models for research on breastfeeding.
Ultimately, the CONCEPTION team believes that the best way of studying which medicines get into breast milk is to combine in vivo, in vitro and in silico models.
How would combining approaches work in practice? ‘The approaches used are directly connected through a continuous flow of information,’ explains Alberto Elmi of the University of Bologna. ‘Moreover, both in vitro and in vivo data feed the mathematical approaches of the in silico platform, and this will further strengthen the other models. In addition, use of the human lactation data collected elsewhere in the project will allow us to validate the in silico, in vivo and in vitro platforms.’
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First direct evidence of the influence of food on skin bacteria
A study by IMI project BIOMAP showed that the type - and amount - of food you eat influences the bacteria that live on your skin, as do smoking, education and even time spent outside.
BIOMAP is working to understand the underlying mechanisms of the skin diseases atopic dermatitis and psoriasis. Human skin is teeming with bacteria, an essential element for skin health but also linked to disease when imbalanced. The BIOMAP team set out to investigate any potential links between a person’s physical traits, lifestyle and their environment, with their skin bacteria. To do so, they gathered skin samples from 647 people and profiled their skin bacteria by DNA sequencing. They were able to confirm established links between the skin microbiota and skin microenvironment, age, body mass index and sex. More intriguingly, they found that dietary macronutrients and total dietary energy were associated with several specific bacterium types, as were smoking, alcohol consumption, skin pH, skin type, trans-epidermal water loss, education and certain environmental conditions and lifestyle factors, such as hours spent outdoors.
This expands our current understanding of what influences skin bacterial community and its makeup. The researchers hypothesise that the skin microenvironment, coupled with host physiology, shapes skin bacteria to a greater extent than with a single skin physiological feature, lifestyle and environmental exposure. In other words, no single environmental or behavioural aspect appears to have a major impact. Future clinical research involving skin microbiota, they say, should acknowledge these associations.
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Clinical trials for infectious disease research, on demand
IMI's COMBACTE projects are the foundation of ECRAID, a network to support the full range of clinical research into new antimicrobial agents.
As it currently stands, clinical studies of new antimicrobial drugs have to be set up from scratch, leading to wasted time and resources. Now a new entity called ECRAID has been set up to be able to quickly and efficiently launch and carry out clinical trials of potential new antibiotics. The new entity will provide the full breadth of clinical studies on infectious diseases, from observational and interventional studies to prevention, treatment, diagnostics, screening, epidemiological, quality of life, and health economics research. It will also support phase one to phase four clinical trials.
ECRAID is an outgrowth of IMI's COMBACTE projects and the EU-funded PREPARE programme. COMBACTE is part of the IMI-funded programme ND4BB (New Drugs for Bad Bugs) progreamme and focuses on improving the clinical development of antibiotics. COMBACTE has been building a high-quality clinical and laboratory research network for new options to treat or prevent bacterial infections in the EU and affiliated countries.
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New non-profit organisation to help usher in EU’s networked and harmonised health data space
The EHDEN project has announced the creation of a new organisation that will support research carried out by partners in the EHDEN network and the wider research community beyond the lifetime of the IMI-funded project.
The EHDEN project has a vision of the future wherein real-world data gathered during routine patient care can be used by the healthcare community to quickly generate high-quality insights that can improve care. Through a network of 98 data partners, the project has harmonised more than 400 million health records, transforming data from disparate databases to a ‘common data model’. This valuable resource has already been used to generate evidence on COVID19 vaccines and potential treatments, diabetes, and other indications.
The new organisation is being launched as a not-for-profit incorporated in the Netherlands, transitioning the project into a long-term sustainable operation from 2024. It will support studies into more diseases and new treatments through study-a-thons and research programmes, continue work on methodological and technical developments of the data and analytics infrastructure, ensure new data partners can join, and further grow the ‘EHDEN Academy’ training programme.
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