What is your role in the REDDIE team at your institution?

As a postdoc in the REDDIE team, my role is multifaceted, aimed overall at contributing to the achievement of the objectives outlined in Work Package 4 (WP4). My responsibilities include drafting analysis plans for the emulation studies we aim to conduct within WP4, managing data by combining relevant datasets from the Danish registries, and conducting detailed analyses in collaboration with the statistical team. Additionally, I contribute to the authorship of scientific papers, encapsulating our findings and methodologies for the academic community.

What are you currently working on within the scope of REDDIE and what are your main goals and objectives in the project?

Currently, I am focused on finalizing the analysis plan for our study comparing GLP-1 and DPP-4 inhibitors. We aim to utilize the Longitudinal Targeted Maximum Likelihood Estimation (LTMLE) method to derive preliminary results very soon. Furthermore, I am supporting data management efforts across other projects in line with the objectives of WP4.

What are some of the most interesting findings or insights that you have gained or are expecting to gain from your research in REDDIE?

One of the most enriching aspects of working on WP4 within REDDIE has been the opportunity for international collaboration. This bi-country initiative has facilitated a cross-pollination of ideas and approaches which is something I find both fascinating and invaluable.

What makes working on the REDDIE project special for you personally?

The Danish WP4 group is an interdisciplinary team and with backgrounds in mathematics, biostatistics, endocrinology, cardiology, and epidemiology, we are able to complement each other's expertise, fostering a learning and working environment that I very much enjoy.

How do you see using real-world data to impact diabetes care in the future?

While randomized trials remain the gold standard for clinical research, I am optimistic about the growing role of Real-World Data (RWD) in uncovering treatment heterogeneity among patients. The advancement of refined analytical methods allows us to leverage RWD more effectively, providing insights that could potentially lead to personalized and improved diabetes care.

Could you share with us what are you currently reading?

I'm currently reading the book Invisible Women: Exposing Data Bias in a World Designed for Men. It's an important book, shedding light on how societal norms and structures often overlook women, treating men as the standard. The book elegantly points out the pervasive bias at all societal levels, from public policy decisions like snow-clearing to emergency management during natural disasters – I highly recommend.

What is your role in the REDDIE team?

I am an alliance manager and working with research and innovation strategies and initiatives at Novo Nordisk, e.g. as a representative in various industry groups at EFPIA and MedTech Europe.

What are you currently working on within the scope of REDDIE and what are your main goals and objectives in the project?

As part of the coordination team and managing board, I participate in the overall project leadership with a special focus on the industry and pharma perspective. The main goal is to bring the relevant stakeholders together to jointly discuss and test how to apply real-world evidence to the various decision-making processes in healthcare provision. This is a common goal believed to improve healthcare for the benefit of patients and society.

What are some of the most interesting findings or insights that you have gained or are expecting to gain from your research in REDDIE?

It is interesting to see how many different approaches to bringing real-world evidence to the table are being considered and tested in different environments, whether locally in some countries, driven by EMA or the EC, or by academia and industry groups. My hope is that we can join forces and work together on aligned solutions, which supplement each other.

What makes working on the REDDIE project special for you personally?

The REDDIE consortium brings together a fantastic team of experts and leaders to tackle one of the key topics in healthcare. It is great to work with such a dedicated and experienced group of people bringing in the broad and diverse perspectives making this a true joint effort.

How do you see using real-world data to impact diabetes care in the future?

Real-world data will be an integrated part of the development and treatment processes in the future, providing more targeted and efficient treatments to patients.

What is your favourite thing when not doing research?

One of my favourite things to do when not doing research is playing music. I play the clarinet in two different orchestras spanning from classical music to popular music of the last 100 years. This is great fun, both challenging and rewarding, when we see people enjoying our concerts.

What is your role in the REDDIE team at your institution?

I am the project coordinator.

What are you currently working on within the scope of REDDIE, and what are your main goals and objectives in the project?

Currently, I am working on the publication guidelines. My main goal is to prove that real-world data are a relevant adjunct to data obtained from randomized controlled trials and that we can develop standards on data type and quality so that real-world data sets can be evaluated for their validity and usefulness to be used as relevant data sources.

What are some of the most interesting findings or insights that you have gained or are expecting to gain from your research in REDDIE?

Currently, we are still in the development phase. Findings will be available in the coming years. However, I have already gained insight into the regulatory aspects of the use of RWD (real-world data).

What makes working on the REDDIE project special for you personally?

It is my great honour and pleasure to work with world leaders in the field of real-world evidence and diabetes care. I am so happy to work with a consortium that is smart and with whom you can also spend a good time during social events.

How do you see using real-world data to impact diabetes care in the future?

RWD will help us to faster adopt findings from RCTs (Randomised Controlled Trials) into clinical care and include special populations (e.g. elderly) into the indications as we can model data for special populations that are normally not represented in clinical trials.

What is one thing you cannot live without?

One thing I cannot live without would be good company, delicious food, and tasteful wine – sorry, these are three, but always go together.

What is your role in the REDDIE team?

I am the principal investigator at Ulm University.

What are you currently working on within the scope of REDDIE and what are your main goals and objectives in the project?

Our research group is currently working on a trial-inspired analysis investigating the efficacy of liraglutide versus placebo on metabolic control in people with diabetes. The main objectives are to compare results between studies using real-world data (RWD) and randomised controlled trials (RCT), to present RWD as an important complement to RCT and further to improve the use of RWD in order to advance research related to diabetes.

What are some of the most interesting findings or insights that you have gained or are expecting to gain from your research in REDDIE?

I am expecting that within REDDIE we will present important and interesting differences, similarities and new aspects when comparing RCT and RWD studies.

What makes working on the REDDIE project special for you personally?

For me exchanging expertise with people from different disciplines on an international level is special and helps to advance my own expertise in diabetes research.

How do you see using real-world data to impact diabetes care in the future?

The use of RWD as a complement to RCT will potentially enhance our understanding of diabetes, guide treatment decisions and improve outcomes for people with diabetes.

What is your favourite thing when not doing research?

One of my favourite things to do when not doing research is running. I love being physically active outside in nature.

What is your role in the REDDIE team at your institution?

I am a junior data analyst in the REDDIE team at University of Padova.

What are you currently working on within the scope of REDDIE and what are your main goals and objectives in the project?

Currently, I am doing a literature review, identifying the strengths and limitations of current methodologies to perform retrospective observational studies and of data-driven simulation models that predict outcomes related to diabetes. Our team aims to propose a new framework to perform retrospective observational studies in an automatic way, and to advance the state of the art on simulation-model building.

What are some of the most interesting findings or insights that you have gained or are expecting to gain from your research in REDDIE?

In these months, I have truly understood the difficulties of analysing real-world data and their lack of standardisation. I expect to learn more about algorithms that can be used to analyse this kind of data and real-world data-driven simulations models that can be applied to the diabetes field to improve the care and quality of life of patients with diabetes.

What makes working on the REDDIE project special for you personally?

To me, the REDDIE project is special and important since it is the focus of my PhD project. Most of my research time is centred on REDDIE and I do hope to give a significant contribution to the project and the diabetes research field.

How do you see using real-world data to impact diabetes care in the future?

In my opinion, one of the most significant impacts of using real-world data to improve patient care for people with diabetes is the development of simulation models, which will provide a new, complementary way of evaluating the efficacy of a new drug or treatment based on real-world evidence. Moreover, the analysis of real-world data will give us the opportunity to study the effectiveness of drugs and/or treatments in patients with diabetes in the real world, which is more complex than the world represented by clinical trials.

What is one thing from your bucket list?

One thing on my bucket list is traveling to Iceland.

What is your role in the REDDIE team at your institution?

I serve as a research assistant within the REDDIE team at the Leicester Diabetes Centre.

What are you currently working on within the scope of REDDIE and what are your main goals and objectives in the project?

Currently, as part of the REDDIE project, my attention is directed towards WP4, focusing on the statistical analysis of the UK National Diabetes Audit (NDA) databases, encompassing descriptive analysis and LTMLE.

Our primary objectives in this project align with the overarching goals of the REDDIE project. These include identifying innovative methodologies for utilizing real-world data (RWD) to inform regulatory decision-making and health technology assessment. Additionally, we aim to investigate the synergies between real-world data (RWD) and randomized controlled trials (RCTs) to enhance the effectiveness, safety, and cost-effectiveness of interventions aimed at diabetes prevention and treatment.

What are some of the most interesting findings or insights that you have gained or are expecting to gain from your research in REDDIE?

The significance of research findings in influencing policymaking based on real-world evidence data cannot be overstated. Additionally, there exists a vast reservoir of RWD that remains largely untapped in research endeavours.

What makes working on the REDDIE project special for you personally?

What makes working on the REDDIE project special for me personally is the rich diversity it encompasses. With researchers and collaborators from various countries and backgrounds involved, the project offers a unique opportunity to engage with a wide range of perspectives, expertise, and cultural insights. This diversity not only enriches our research discussions and methodologies but also fosters a vibrant and inclusive working environment where everyone's contributions are valued and respected.

How do you see using real-world data to impact diabetes care in the future?

Using real-world data to impact diabetes care in the future holds significant promise for improving patient outcomes, advancing research, and informing healthcare policies. Here are several avenues through which real-world data can play a pivotal role in improving diabetes care:

• Personalized Treatment Approaches.
• Early Detection and Prevention.
• Continuous Monitoring and Management.
• Research and Development.
• Healthcare System Optimization.
• Patient Empowerment and Engagement.

What is some thing you like to do when not doing research?

One of my favourite pastimes outside of research is delving into literature on leadership, talent management and identification and mentoring. Given my profound interest in these topics, I find it difficult to go to bed without at least reading a brief abstract.

What is your role in the REDDIE team at your institution?

I am the technical lead for the activities related to the simulation of virtual individuals with diabetes.

What are you currently working on within the scope of REDDIE and what are your main goals and objectives in the project?

My work primarily focuses on applying advanced computational techniques, such as machine learning and data mining, to healthcare-related problems. In REDDIE, I will contribute to developing innovative algorithms for patient simulation using real-world data. Our aim is to advance the field of virtual trials in diabetes research by creating tools capable of simulating the progression of diabetes in virtual patients. This includes predicting long-term diabetes-related complications, enabling us to evaluate interventions (e.g., lifestyle change, or change of medication use) and their impact on outcomes through in silico testing.

What are some of the most interesting findings or insights that you have gained or are expecting to gain from your research in REDDIE?

I expect to be able to hone my understanding of how to best optimise virtual patient simulation for the field of diabetes research, in a way that maximises the potential of real world data to synthetically test the effect of interventions or new medications.

What makes working on the REDDIE project special for you personally?

REDDIE marks my first foray into the realm of diabetes research. I view my participation as an excellent chance to make meaningful contributions to this field, leveraging and expanding my expertise while collaborating with a consortium of high-skill and enthusiastic professionals.

How do you see RWD impacting diabetes care in the future?

Testing interventions via virtual patients will allow to anticipate the effect of new treatments on the general population in a safe way as part of the clinical trials. Real-world data are crucial in this process, allowing simulation tools to be robust and effectively representing the population of interest.

What do you do when you're not working?

One of my favourite things to do when not doing research is yoga.

What is your role in the REDDIE team at your institution?

I am the principal investigator at Radboud University Medical Centre.

What are you currently working on within the scope of REDDIE and what are your main goals and objectives in the project?

My involvement mainly concerns providing input from a clinical perspective and the consolidated Hypo-RESOLVE database on hypoglycaemia in people with insulin-treated diabetes.

What are some of the most interesting findings or insights that you have gained or are expecting to gain from your research in REDDIE?

I hope that REDDIE will provide the necessary link between RCT (randomised controlled trials) data and RWE (real-world evidence).

What makes working on the REDDIE project special for you personally?

It is great to collaborate with such a motivated group of experts, many of whom I know from a previous collaboration (ie Hypo-RESOLVE).

How do you see RWD impacting diabetes care in the future?

I believe that this is becoming more important, once regulators and other stakeholders start to accept its value for research and providing evidence for use in clinical practice.

What do you do when you're not working?

One of my favourite things to do when not doing research is taking my mountain bike into the hills surrounding the Maastricht area (okay, we don’t have mountains…)

What is your role in the REDDIE team at your institution?

I am leading on work package 2 and work package 4 from the University of Leicester. This includes the identification and evaluation of diabetes-related databases from around the world to create a comprehensive summary of the data they contain. This list will be used to establish a set of criteria for assessing data quality and to develop a set of rules that scientists can follow when using and developing real-world datasets.

What are you currently working on within the scope of REDDIE and what are your main goals and objectives in the project?

My work includes conducting a review to identify real-world databases in diabetes. This review will be used to inform guidance for assessing the suitability of real-world data to answer specific research questions. I am also coordinating analysis on the National Diabetes Audit collected in England to answer the aim of work package 4, which is to compare results from randomised controlled trials and results from real-world data sources on glucose-lowering therapies in diabetes. My goal is to identify real-world databases in diabetes and make this information as findable as possible for other researchers to benefit the wider research community. The RWD databases overview can be found here https://www.reddie-diabetes.eu/research/rwd-dashboard.

What are some of the most interesting findings or insights that you have gained or are expecting to gain from your research in REDDIE?

I hope as part of the REDDIE project we can help to show the utility of real-world data to complement the findings of RCTs. Particularly, I hope to provide insight into minority groups which are currently underrepresented within traditional RCTs.

What makes working on the REDDIE project special for you personally?

The ability to utilise novel analytic techniques, whilst collaborating with researchers from across Europe, to explore how real-world data can bring novel insight for individuals living with diabetes is what first attracted me to the REDDIE project.

How do you see RWD impacting diabetes care in the future?

I hope real-world data can be used in conjunction with RCT findings to improve the speed and efficiency of regulatory and prescribing decision-making for individuals living with diabetes.

What do you do when you are not working on your research?

One of my favourite things to do when not doing research is go for walks in the countryside with my partner and our dog.

What is your role in the REDDIE team at your institution?

We coordinate the work package which addresses the challenges treatment for diabetes poses to regulators and payers.

What are you currently working on within the scope of REDDIE and what are your main goals and objectives in the project?

We are aware that data from other than randomised controlled trials provide important information, but frequently, these data are not easily accessible. Part of our work looks at so-called ‘synthetic data’ which we hope will help ease that problem. We are also working to identify how real-world data can help the challenges that are more common in treatments for diabetes than in other disease areas.

What are some of the most interesting findings or insights that you have gained or expect to gain from your research in REDDIE?

We believe that ‘synthetic data’ has the potential to help people understand how well new and, indeed, existing treatments work for people living with diabetes.

What makes working on the REDDIE project special for you personally?

Research is, by definition, collaborative; the REDDIE project brings together people with fantastic skill sets across many countries and, by introducing them to each other, helps not only current, but future research.

How do you see RWD impacting diabetes care in the future?

Real-world data will continue to complement data on effectiveness and cost-effectiveness from randomised trials and has a continuing and important role in describing the characteristics of the people most likely to receive treatments. Policymakers value ‘good’ real-world data.

What do you do when you're not working?

One of my favourite things to do when not doing research is to jump out of a swimming pool and head to the opera.

What is your role in the REDDIE team at your institution?

As a project manager, I am helping our REDDIE partners to make a successful project within deadlines, set objectives and with good teamwork and communication.

What are you currently working on within the scope of REDDIE and what are your main goals and objectives in the project?

Currently, I am working on the organization of the second Multistakeholder meeting that will happen in January next year. All the cluster projects are going to participate and share progress and insights into their results with regulators, notified bodies, HTA agencies and other stakeholders.

My main goal is always that we all do the best we can by the due date and that this does not distract us from our main scientific goals. All WPs are important to make a full circle of activities.

What makes working on the REDDIE project special for you personally?

In my family, I have a history of people living with diabetes and to be able to make an impact in this field gives a rewarding feeling. Throughout the project, I continuously learn about the subject and the industry which makes me appreciate the work that is already done.

How do you see using real-world data to impact diabetes care in the future?

Having better insights into how people living with diabetes spend their daily lives and feel about their treatment is truly important to make as much of an impact as possible. This can not be done without data. If we can make guidelines at least for the territory of the EU so we could actually compare better what is happening in different countries, even better.

Could you share with us what are you currently reading?

Right now, I’m reading about social interactions within organizations and a couple of science fiction books.