- Focus on IMI’s AMR projects
- Can real world data replicate a clinical trial? EHDEN study suggests yes
- How can we make clinical trials more kid-friendly?
- For small companies, IMI projects can help tap into new markets
- Trial of second Ebola vaccine starts in Democratic Republic of the Congo
- Meet IMI’s big data projects at BioDataWorld 2019
Harnessing the power of partnerships to develop life-saving vaccines
Vaccination is one of the most effective lifesaving public health interventions the world has as its disposal. Vaccines have already allowed us to wipe out two mammalian diseases (smallpox and rinderpest), and control many more, including diphtheria, tetanus, polio, some forms of meningitis, otitis, whooping cough, pneumonia, hepatitis A&B, measles, rubella, mumps, chicken pox, and influenza. Yet despite these successes, challenges remain in the development and uptake of vaccines.
In an article for European Files, IMI Executive Director Pierre Meulien explains why public-private partnerships (PPPs) like IMI are a good place to address these challenges. ‘Vaccine research lends itself well to the PPP model because there are many areas where there is a need for collaboration between industry, academic researchers and others to create multi-stakeholder groups that have the expertise, data and resources to address major gaps and solve challenges in vaccine research and development,’ he writes. ‘Only by working together in this way can we hope to accelerate the time from the research bench to clinical assessment in humans.’
Meet IMI’s newest projects
IMI’s project portfolio is constantly growing! The newest members of the IMI family are:
- 3TR - The aim of 3TR is to shed new light on the factors that determine whether or not patients with certain diseases are likely to respond to a given treatment. 3TR will focus on seven diseases: systemic lupus erythematosus (SLE), rheumatoid arthritis, multiple sclerosis, ulcerative colitis, Crohn’s disease, asthma, and chronic obstructive pulmonary disease (COPD).
- Immune-Image - Immune-Image aims to pioneer the use of non-invasive imaging technologies to track the activity of immune cells in the body. Ultimately, this will make it easier to predict how patients will respond to immunotherapies and monitor their progress during treatment.
- Trials@Home – Trials@Home will study how digital technologies and wearable devices could make clinical trials easier for patients, by cutting the number of times they need to visit the clinic.
The ‘projects and results’ section of the IMI website offers a wealth of information on our projects. In addition to a factsheet on every project, we also feature success stories and a catalogue of tools produced by our projects that are accessible to the wider scientific community. Finally, an interactive map allows visitors to explore where IMI has project partners and how much funding they receive.
Focus on IMI’s AMR projects
Antimicrobial resistance (AMR) is becoming one of the defining problems of our time. As bacteria become resistant to the drugs that are supposed to kill them, scientists, policy makers and the pharma industry are looking at different ways to fix the problem before it’s too late. IMI has invested heavily in AMR research. To date, we have invested almost €800 million on 14 projects. Throughout November, we turned the spotlight on some of IMI’s projects in this area and explored the different angles from which they’re tackling the problem.
Read the articles
- Focus on AMR
- New antibiotics won't stop AMR. Luckily, there are other things we can try. – editorial by Pierre Meulien, IMI Executive Director
- Why it's so hard to make new antibiotics
- A very promising antibiotic just started clinical trials
- Technology, not instinct, should guide antibiotic prescribing
Can real world data replicate a clinical trial? EHDEN study suggests yes
IMI’s EHDEN project 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. The findings, which focus on the pros and cons of different types of knee replacement surgery, are published in the journal Lancet Rheumatology. They show that it is possible to harness clinical data (such as electronic health records) from different sources and use it to generate information that could help patients and doctors to make better decisions about their care.
‘Randomised controlled trials remain the gold standard for establishing efficacy,’ the EHDEN team concludes in the paper. ‘However, we feel that this study shows the value of real world evidence for complementing the evidence produced from randomised trials.’
‘This is particularly relevant for less common outcomes including safety and adverse reactions,’ adds one of the lead authors of the paper, Daniel Prieto-Alhambra of the University of Oxford, noting that the EHDEN team is keen to build on this experience. ‘Future study-a-thon’s are planned during the duration of EHDEN. Watch this space!’
- IMI’s news story
- The Lancet Rheumatology paper
- Watch a video on the EHDEN project and the study-a-thon (the presentation on the study-a-thon starts at 15:20)
- EHDEN website
How can we make clinical trials more kid-friendly?
IMI’s c4c project is inviting children and young people to help decide how clinical trials with child participants should be run. Children taking part in a clinical trial, depending on their maturity and understanding, have to sign an assent form declaring that they understand the purpose of the study and its benefits and risks, and that they agree to participate. However, these forms are not always child friendly. In an interview with the IMI Programme Office, Joana Claverol of the Hospital San Joan de Déu in Barcelona explains how she and her colleagues are setting up a European network of advisory groups made up of children and young people with different diseases to get their help to improve the different research projects developed at the hospital.
‘We want these children to participate not only as participants in the trial, but to act as advisors on trial design, to review protocols, to assess patient documentation, and to talk about paediatric and medical needs,’ she says. The network will contribute to the project’s goal of building a network of hospitals in multiple countries that can undertake high-quality clinical trials for children, across all paediatric age groups and diseases in children.
For small companies, IMI projects can help tap into new markets
Swedish SME Truly Labs specialises in preclinical research and is a partner in IMI’s TRISTAN project, which is investigating how imaging techniques could be used to improve medicines safety. In an interview with the IMI Programme Office, CEO Karin von Wachenfeldt PhD sets out the benefits of IMI for SMEs. ‘We’ve definitely found it to be a positive experience in terms of networking and meeting new contacts,’ she says. Looking to the future, she explains that TRISTAN will help them offer even more specialised services. ‘The imaging biomarkers are a very niche product and we will be one of the very few centres in the world that can do that,’ she says. ‘That may attract companies that want to study drugs with a certain type of profile.’ More broadly, she concludes that IMI ‘enables work that cannot be performed outside a bigger team effort’.
Trial of second Ebola vaccine starts in Democratic Republic of the Congo
An international consortium has started a large-scale clinical trial of an Ebola vaccine regimen in the Democratic Republic of the Congo (DRC), which is currently experiencing the second worst Ebola epidemic in history. The new trial has been designed to prevent the spread of the epidemic beyond the areas that are currently affected, and if possible to gather crucial information about the effectiveness of the vaccine to be better prepared to fight Ebola in the future. The vaccine regimen, which is manufactured by the Janssen Pharmaceutical Companies of Johnson & Johnson, is being offered to adults and children aged a year or older in communities near the outbreak who are considered at risk.
A number of organisations have contributed to the development of the vaccine regimen, including IMI through the Ebola+ programme. Specifically, the projects EBOVAC1, EBOVAC2 and EBOVAC3 supported earlier clinical trials of the vaccine regimen, while EBOMAN supported its manufacture. Finally, the EBODAC project successfully facilitated the engagement of local communities, something it is also poised to do in this latest trial in the DRC.
Find out more
Meet IMI’s big data projects at BioDataWorld 2019
IMI’s big data projects will promote their activities at the BioDataWorld Congress 2019 in Basel, Switzerland, on 4-5 December 2019. The projects will share their approach to improving health outcomes in the following sessions:
- The pro’s and con’s of the different IMI projects approaches. IT and high-tech aspects (Roundtable 27, 4 December at 11:40)
- The need for data communities in Europe, and why should you care? (Roundtable 25, 5 December at 11:40)
- It is now or never! Connecting data communities with clinical research communities (Lunchtime panel, 5 December at 12:30)
- Connecting the dots to benefit patients: This is how we do it, but we need you too! (IMI Showcase, 5 December at 15:10)
The projects participating in these sessions are: HARMONY (big data and blood cancers), EHDEN (health data and evidence network), BigData@Heart (big data and heart disease), PIONEER (big data and prostate cancer), and ROADMAP (big data and Alzheimer’s disease). All projects are part of IMI’s Big Data for Better Outcomes programme.