Real World Evidence – RWE

Real World Evidence (RWE) and Real World Data (RWD) can be defined as health-related data / evidence obtained from multiple sources outside of traditional clinical research trials. Accordingly, RWE is typically valued based on its’ potential in complementing and validating clinical trial data.

According to the FDA

  • RWD is “the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources”
  • RWE is “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD” 

RWE can be used, for example, to demonstrate the value of a certain treatment or technology for patients, healthcare service providers and society. Due to comprehensive healthcare, data in digital format, a personal ID, and progressive research legislation, Finland is a true model country for Real World Evidence studies. 

Medaffcon has the most extensive experience in analyzing and utilizing RWE in Finland. We have been conducting RWE studies since 2013 when the Biobank Act came into effect and allowed for more extensive use of the data when conducting research. Our RWE studies are closely related to health economic perspectives on cost-effectiveness of interventions. We are closely involved in supporting and developing the unique data sources in Finland. 

We provide individually tailored RWE research services to different healthcare actors. Our scientific experts and bioinformaticians ensure that the correct research methods and data sources are used to answer your questions. 

Medaffcon’s RWE studies have concentrated on, for example:

  • Disease burden of different patient groups
  • Use of healthcare resources
  • Diagnostics of rare diseases
  • Treatment lines and outcomes
  • Mortality
  • Characteristics of patient subgroups
  • Outlining regional treatment practices
  • Cost-effectiveness

 

More information

Check out our publications

Read about how the U.S. Food and Drug Administration – FDA defines RWE: Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.

Read more about the RWE possibilities in Finland. What is Real World Data and Real World Evidence? What does it look like and how can it be utilized? What makes Finland’s real world data so special?

 

 

”As a biostatistician, I know the statistical methods and how they can be utilized in data analysis. I’m familiar with the different data sources, their potential and limitations. My job is to process and analyze raw data, and to provide statistical evidence for the customer in response to burning questions, to support decision-making, and to fill in data gaps”
Iiro Toppila
Biostatistician & Data Analysis Lead, Medaffcon Oy
”The number of RWE studies has increased since stakeholders within the healthcare industry have an increasing demand for knowledge-based decision making tools that needs to be fulfilled. The future; therefore, has an ever-increasing emphasis on RWE.”
Mariann Lassenius
Sr. Scientific Advisor & RWE Lead, Medaffcon Oy
”RWE complements our understanding of the effectiveness of interventions and resource use in the Finnish population, thereby reducing uncertainty in health-economic modeling.”
Tatu Sainio
Sr. Health Economist & Access & HE Lead, Medaffcon Oy

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Mariann Lassenius
Sr. Scientific Advisor
RWE Lead

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Our Real World Evidence Experts:

Mariann Lassenius
Sr. Scientific Advisor
RWE Lead

Mariann Lassenius

Sr. Scientific Advisor
RWE Lead
PhD

+358 50 345 2393 LinkedIn

Mariann joined Medaffcon’s team in 2016 after finishing her PhD. The transition to real world evidence (RWE) research was a natural continuum to her previous research career. Through RWE studies, she has had the privilege to gain a broad insight into working with different stakeholders within the healthcare field. The vast proportion of her days goes towards interacting with clients, planning and performing RWE studies, and supporting Medaffcon’s RWE team. Subjects that keep her work interesting are the vast variability of customers and projects, problem-solving, and interacting with people.

“The number of RWE studies has increased since stakeholders within the healthcare industry have an increasing demand for knowledge-based decision making tools that need to be fulfilled. The future, therefore, has an ever-increasing emphasis on RWE”.


Iiro Toppila
Biostatistician
Data Analysis Lead

Iiro Toppila

Biostatistician
Data Analysis Lead
M.Sc. (Tech.)

+358 44 314 1597 LinkedIn

Iiro joined Medaffcon in March 2017 as a Biostatistician. For the preceding four years, he has worked as a research assistant in an academic study group, analyzing clinical and genetic patient data. Iiro holds a Master of Science degree in Technology in Bioinformation Technology.

Iiro’s strengths include his strong expertise in statistics and data-analysis, hands-on experience in working with sensitive patient data, and strong interdisciplinary communication skills with experts from various fields. In the field, he is particularly interested in the large data amounts made available with the revolution of technology and how the information received such data can potentially be utilized to draw concrete conclusions, both in order to understand the nature of diseases and to advance the goals of the pharmaceutical industry and patient treatment.

“Machine learning and AI-based solutions will have a major impact on the healthcare sector now and in the future. However, effectively utilizing the already collected and available health-data will have a higher importance in order to improve health-care”.


Tatu Sainio
Sr. Health Economist
Access & HE Lead

Tatu Sainio

Sr. Health Economist
Access & HE Lead
M.Sc. (Economics & Health Economics)

+358 44 530 5525 LinkedIn

Tatu joined Medaffcon in the fall of 2016. Tatu holds two master’s degrees, majoring in Marketing and Health Economics. Before joining Medaffcon, he worked in the pharmaceutical industry at Boehringer Ingelheim as an Account Manager. At Medaffcon, Tatu works mainly with health technology assessments and is the access & health economics team lead. Through his educational and professional background, Tatu has a wide range of expertise in the pharmaceutical industry and understands the needs of each function.

Tatu’s strength is his comprehensive understanding of the pharmaceutical industry and healthcare environment. Tatu is particularly interested in the possibility to turn data into understandable information to support healthcare decision-making.

“I love the hype around the utilization of real-world effectiveness and cost-effectiveness data. Now we need steps to include the data as a systematic part of the decision-making process, which allows the optimal allocation of resources”.


Liisa-Medaffcon-RWE
Liisa Ukkola-Vuoti
Scientific Advisor
Liisa-Medaffcon-RWE

Liisa Ukkola-Vuoti

Scientific Advisor
PhD

+358 400 565 536 LinkedIn

Liisa joined Medaffcon in January 2020. She has over ten years of experience of working as a scientific advisor and research scientist for private and public sector organizations. Liisa holds a PhD in medical genetics, and she mentions that especially the therapeutic areas related neurology and psychiatry appeal to her.

Liisa’s strengths include strong expertise on medical sciences and research, as well as on creating evidence-based content, because she also has experience of being a science book author. Establishing cross-scientific collaboration, scientific exchange, and creating networks are one of her key work philosophies.

One of her main professional interests is the secondary use of health-related data to create real-world-evidence in order to improve and develop treatment practices. ”Due to the unique registries and data lakes available in Finland, in principle all the required data is already available or accumulating all the time, which makes it important to utilize this real-world-data to improve patient care and general well-being.”


Sanna Honkala
Scientific Advisor

Sanna Honkala

Scientific Advisor
PhD

+358 50 327 3440 LinkedIn

Sanna joined Medaffcon’s team in November 2019. In her PhD, she studied the potential of high-intensity interval training (HIIT) in the prevention and management of type 2 diabetes. After defending her PhD in 2018, she worked as a post-doctoral researcher at the University of Turku. In addition, Sanna has experience working as an entrepreneur in the field of work-wellbeing. As a base-education, she has two master’s degrees (Biomedicine and Exercise Physiology).

Sanna’s strengths include strong expertise in science, diverse educational background, excellent management skills and above all, her positive nature. She is fascinated by the dynamics and endless innovative opportunities in the healthcare industry. “It is extremely interesting to see how individual treatment paths can be tailored in the future for example based on the genome or different biomarkers. In addition, new digital solutions in the prevention and management of different diseases will surely improve health and the daily lives of many individuals”.


Kristiina Uusi-Rauva
Scientific Advisor

Kristiina Uusi-Rauva

Scientific Advisor
PhD

+358 40 047 3314 LinkedIn

Kristiina joined Medaffcon’s RWE team in the fall of 2019. She holds a PhD and her doctoral dissertation concentrated on cell biology of a rare neurological disease. After defending her PhD, Kristiina worked on projects using iPS cell technology in several different research groups for rare diseases. In addition, she has experience in the most common diseases, as she has worked with diabetic research, for example.

“In this work, we can see from the field how know-how is effectively acquired and for what purposes it is used in healthcare. I look forward to seeing the full potential of biobank sample collections for future use in RWE research, including rare diseases”.


Jenni Hällfors scientific advisor Medaffcon RWE
Jenni Hällfors
Scientific Advisor
Jenni Hällfors scientific advisor Medaffcon RWE

Jenni Hällfors

Scientific Advisor
PhD

+358 40 776 0883 LinkedIn

Jenni joined Medaffcon in September 2020. She has over a decade of experience working as a scientific researcher. Before joining Medaffcon, Jenni has worked as a scientific consultant and project manager in a young and growing biotechnology company. Jenni has a PhD in medical genetics, and her studies have focused on the genetic epidemiology of non-communicable diseases.

Jenni has strong expertise in science from different chronic disease areas and excellent project management skills. Her strengths include effortless communication with versatile stakeholders and enthusiasm towards scientific collaboration. “Numerous national registers and data lakes in Finland are like treasure chests. They contain a wealth of real-world data from all therapy areas that can quickly transform into real-world evidence. The best thing about my job as a scientific advisor is to be able to unlock the knowledge and help our customers to utilize it in a way that innovates new, personalized treatment options and improves the level of patient care.”


Bettina Mannerström, Scientific Advisor, Medaffcon RWE team
Bettina Mannerström
Scientific Advisor
Bettina Mannerström, Scientific Advisor, Medaffcon RWE team

Bettina Mannerström

Scientific Advisor
PhD

+358 40 574 7127 LinkedIn

Bettina joined Medaffcon in February 2021. She has more than 15 years of experience of scientific work, in which the clinical applicability has always been in focus. Before joining Medaffcon, Bettina held the position of senior researcher at University of Helsinki. Bettina received her MSc degree from Åbo Akademi University during which she spent a year at University of Victoria, Canada. She received her PhD in tissue engineering from University of Tampere. As a result of a long career in science, Bettina also has a title of docent in Cell Biology.

Bettina has a strong background in cross disciplinary projects, working in multicultural teams and a solid interest in collaboration with health care professionals. Multidisciplinary projects where the knowledge of various experts is utilized for improved patient care are close to heart. In Medaffcon, Bettina is fueled by working with, sharing and applying scientific knowledge for advancing healthcare.


Riikka Mattila, Scientific Advisor, Medaffcon RWE
Riikka Mattila
Scientific Advisor
Riikka Mattila, Scientific Advisor, Medaffcon RWE

Riikka Mattila

Scientific Advisor
PhD

+358 50 545 9108 LinkedIn

Riikka joined Medaffcon in February 2021. She has a wide-ranging experience from different therapy areas from atherosclerosis and birth asphyxia to neurodegeneration. She has more than 15 years of experience in research, three of which in Max Planck Institute in Germany. Her PhD thesis from 2011 focused on cholesterol metabolism.

Riikka’s strenghts include broad know-how and interest in diverse therapy areas, as well as enthusiasm and experience in both written and verbal scientific communication. At Medaffcon she enjoys varied projects and effectiveness of research.

Real world evidence fascinates Riikka because there is so much data, and more accumulating all the time, and most of this data is unused. There is potential for findings to support clinicians and the pharmaceutical industry, as well as alleviate the lives of patients. She is also happy that decisions in health care are increasingly evidence based.


Tanja Nieminen
Health Economist & Scientific Project Manager

Tanja Nieminen

Health Economist & Scientific Project Manager
M.Sc. (Health Economics & Economics)

+358 50 328 6651 LinkedIn

Tanja joined Medaffcon’s team in November 2016. Before that, she worked as a researcher at the National Institute for Health and Welfare. Tanja has also worked in an international research group, as a course instructor as well as in financial administration and customer service. She holds MSc degrees in both Health Economics and in the field of Economics and Business Administration.  

Tanja’s strengths include her educational and occupational background in health economics from Finland and abroad. Tanja has a special interest in utilizing real-world evidence data to be used in evaluations. “By utilizing data resources to support decision-making we become more aware of how scarce resources should be allocated”. 


Samuli Tuominen
Data Scientist

Samuli Tuominen

Data Scientist
M.Sc. (Statistics)

+358 40 520 8158 LinkedIn

Samuli joined Medaffcon in November 2018. He acquired a master’s degree in Statistics at the University of Helsinki, specializing in Bioinformatics in September 2018. Before joining Medaffcon, Samuli had two years’ worth of experience in research as a research assistant at the University of Helsinki, where he contributed to unraveling the genetic and epigenetic background of psychological characteristics (Depsy-group).

Samuli is especially interested in producing influential research data based on information on real-world patients. He is also interested in applying varying statistical and machine learning methods. Samuli has a broad theoretical and methodological understanding, as well as experience in working with big data. He is a problem solver and has an analytical take on work.

“I see that the health sector is being transformed by digitalization. I am excited to further develop the new opportunities made possible by the automated collection of patient data”.


Johanna Vikkula - Medaffcon - Data Analysis
Johanna Vikkula
Data Scientist
Johanna Vikkula - Medaffcon - Data Analysis

Johanna Vikkula

Data Scientist
M.Sc. (Tech.)

+358 45 670 8893 LinkedIn

Johanna joined Medaffcon on February 2020 just after finishing her masters’ degree at Aalto University with major in bioinformatics and digital health. Previously, Johanna has been working as a research assistant both in brain imagining and in computational systems biology while reinforcing her knowledge in signal processing, analyses of genetic data, artificial neural networks, and development of new methods and tools to analyse genetic data. Johanna possesses strong knowledge in analysing genetic data thanks to broad know-how in life sciences but also in data and computational sciences. Johanna is a solution-oriented team worker, who does not fear to set goals high.

Johanna is interested in enhancing healthcare through bioinformatics and data sciences by combining both the medical and the computational know-how to cure diseases, improve healthcare and take step towards more personalised healthcare.

“I eagerly wait how the genome sequencing and gene testing revolutionise the medical field and boost more personalised treatments. Also, I believe that one day, we will have artificial intelligence as a standard tool for aiding doctors to diagnose and treat patients.”

 


Juhani Aakko Data Scientist Medaffcon
Juhani Aakko
Data Scientist
Juhani Aakko Data Scientist Medaffcon

Juhani Aakko

Data Scientist
D.Sc. (Tech.)

+358 400 488 424 LinkedIn

Juhani joined Medaffcon in October 2020 as a data scientist. At Medaffcon Juhani conducts projects for the social and healthcare sector developing data driven decision-making in the field. Prior to joining Medaffcon, Juhani has worked as a data scientist in a global IT company as well as a scientist at the University of Turku in the Medical Bioinformatics Centre (MBC) and Functional Foods Forum (FFF). Juhani holds a Doctor of Science in Technology degree (2017) and the topic of his thesis was the development of human gut microbiota in early infancy.

Juhani has experience from applying statistical and machine learning methods in medicine and due to his multidisciplinary background, he can easily communicate with people with varied expertise ranging from clinicians to IT-professionals. “Knowledge management and business intelligence have become hot topics also in the social and healthcare sectors. It is very interesting to be involved in harnessing the vast amounts of data available in the systems to actual usable information to support decision making. Both traditional statistics as well as advanced analytics and artificial intelligence will be in a key role in this job.”