RWE – From real world data to real world evidence

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

Medaffcon has conducted RWE studies from 2013 onwards; we thus hold a wide-ranging experience in the analytics and utilisation of real world data. We are intensively involved in supporting the development of biobanks, and our cooperation networks with biobanks and other register holders are strong.

In Medaffcon’s RWE studies, we have gathered new knowledge in different therapeutic areas, including:

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

 

Real World Evidence tailored to your needs!

Our process for conducting studies is clear and has been proven effective. Our scientific experts and bioinformaticians ensure that the right research methods and data sources are utilised to answer your question.

The entire process is conducted with solid RWE knowledge and expertise.

Comprehensive information on diverse information sources

 

 

Examples of clinical data used in RWE study

 

 

RWD linked to a social security number

 

 

Examples of Finnish hospital Biobanks

 

 

 

Examples of completed studies with Auria biobank:

2017

A biobank and health register analysis of burden of disease in severe asthma or COPD patients

GSK Finland

This study surveys the status and characteristics of patients with severe asthma or COPD, diagnosed in the hospital district of Southwest Finland during 2004-2015. Information regarding treatment, health care resource use and associated costs, as well as mortality will be explored.

Clinical characteristics of the Multiple Myeloma patient cohort diagnosed in Southwest Finland during 2004-2017

Amgen AB Finland

Multiple myeloma (MM) is the second most common hematological cancer representing 10-15% of all hematological malignancies. MM results from the clonal expansion of monoclonal plasma cells in the bone marrow, leading to increased secretion of abnormal immunoglobulin into urine and / or peripheral blood. Overproduction of the immunoglobulin fragment causes several deleterious systemic effects, leading to symptoms typically affecting bones and renal function. While MM still remains mostly incurable, the overall survival of MM patients has improved significantly due to the development of more effective therapies.

2016

Eosinophilic asthma

AstraZeneca

Asthma is a heterogeneous disease, often characterised by chronic inflammation of breathing organs. New treatment options have been created for the treatment of serious asthma, however, further information is needed on the biological markers that could be used in the diagnosis and follow-up of patients as well as in the evaluation of the prognosis of different phenotypes and endotypes. The aim of this non-interventional retrospective register study is to examine the significance of eosinophil levels in difficult asthma by assessing the characteristics of these patients and their use of healthcare resources.

The special characteristics of chronic lymphocytic leukaemia in the Hospital District of Southwest Finland in 2004–2013

Abbvie

Chronic lymphocytic leukaemia (CLL) is the most common haematological cancer in Western countries. It is typically found as a coincidental finding in connection with other examinations. While asymptomatic CLL typically is not treated, commonly used treatment options in the most difficult forms of the disease include chemoimmunotherapy and other new cancer-specific drugs. The treatment of CLL has developed immensely during the past ten years and therefore the prognosis has improved in all variants of the disease. This study determines the current situation of CLL, e.g. characteristics of the patient population, used treatment regiments and associated outcomes. With the information obtained, it will be possible to evaluate treatments needed in the future and how much resources they require from the healthcare.

2015

Examining the epidemiology, treatment, comorbidites and prognosis of rare immunological haematological diseases in the Hospital District of Southwest Finland in 2003–2014

Novartis Finland Oy

Chronic immunological thrombocytopenic purpura (ITP) and aplastic anaemia (AA) are rare autoimmune-based blood disorders. The exact causes of these diseases are not fully known. The prognosis of aplastic anaemia, in particular, was very poor 40 years ago as estimated survival of a patient with serious AA was only 1–2 years from the diagnosis. This study examines the prevalence, prognosis and complications of ITP and AA, related costs and treatments used. The study provides also valuable information of the impact of the treatments on prognosis of the patients.

Study on the epidemiological prevalence of melanoma, treatment effectiveness and the use of healthcare resources in the Hospital District of Southwest Finland

Novartis Finland Oy

Metastatic melanoma is a rapidly progressing disease with poor prognosis. Only in recent years, with the introduction of new effective therapies, improvements in the overall survival have been achieved. In particular, BRAF inhibitors and immunotherapy provide new treatment options for a subset of patients. Further information is, however, warranted to clarify the value of different biomarkers indicating the likely responders that would benefit from these different therapies. This study provides information on the use of different treatment options for patients with melanoma, effectiveness of the treatments used, observed comorbidities as well as utilization of healthcare resources.

Study on the epidemiological prevalence of polycythemia vera

Novartis Finland Oy

Polycythemia vera (PV) is a slowly progressing disease which can further develop into myelofibrosis or acute leukaemia in a subset of PV patients. This study examines how PV patients are divided into groups of low and high risks, and which risk factors influence the progression of polycythemia vera into either myelofibrosis or acute leukaemia. This study increases knowledge on the epidemiology of polycythemia vera and the potential factors impacting its prognosis.

2014

Study on the epidemiological prevalence and postoperative treatment of acromegaly in the Hospital District of Southwest Finland

Novartis Finland Oy

Acromegaly is a rare disease resulting from excess growth hormone. In most cases, the disease is caused by a pituitary tumour. This study provides information on the proportion of acromegaly patients whose growth hormone levels do not normalize after the removal of the pituitary tumour and proportion of patients that need somatostatin analogue treatment in order to obtain clinical response. In addition, the comorbidities between patients with instable growth hormone levels and those with recovered hormone levels will be compared. This study provides information for more optimized targeting of treatments for patients with acromegaly.

Study on the epidemiological prevalence of myelofibrosis, polycythemia vera and essential thrombocythemia and the overall survival of patients with myelofibrosis in the Hospital District of Southwest Finland

Novartis Finland Oy

Myelofibrosis (MF) is a slowly progressing disease with poor prognosis. While improvements in overall survival of patients with MF have been achieved, a proportion of MF patients develop subsequently acute leukaemia. This study assesses the proportion of MF patients whose disease transforms to leukaemia and the putative significance of JAK2V617F gene mutation in this process. This study increases knowledge on the epidemiology of myelofibrosis and the potential prognostic factors of the disease.

”As a biostatistician, I know the statistical methods and how they can be utilized in data analysis. I know different data sources, their potential and limitations. My job is to process and analyze raw data, and provide statistical evidence for the customer to response the burning questions, to support decision-making, and to fill the data gaps.”
Iiro Toppila
Biostatistician & Data Analysis Lead, Medaffcon Oy

We are more than happy to tell you more!

Mariann Lassenius
Sr. Scientific Advisor
RWE Lead

Contact us

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 get a broad insight into working with different stakeholder within the healthcare field. The vast proportion of her days goes to interacting with clients, planning and performing RWE studies, and supporting Medaffcon’s RWE team. Things that keep her work interesting are the vast variability of customers and projects, problem-solving, and interacting with people.

“RWE studies have increased since stakeholders within healthcare have an increasing demand for knowledge-based decision making that needs to be fulfilled. The future therefore has an ever-increasing emphasis on RWE.”


Jaana Ahlamaa
Medical Director

Jaana Ahlamaa

Medical Director
MD (Specialist in Surgery), PhD

+358 50 576 7325 LinkedIn

Jaana established Medaffcon in 2009. Prior to that, she worked in expert and management positions in the pharmaceutical industry for almost ten years. Jaana has also worked as a hospital doctor and is a specialist in surgery. In 1999, she defended her doctoral thesis on health policy related to customer payments in healthcare.

Jaana’s most essential contribution to Medaffcon’s team is her wide-ranging experience and expertise. Jaana is particularly interested in the future development of the Finnish healthcare sector. Especially the use of knowledge in decision-making and the new opportunities brought by digitalization fascinates Jaana. “I am especially looking forward to how we can improve personalized treatment options in healthcare and systematically evaluate the effectiveness and cost-effectiveness of treatments”.


Päivikki Hemmilä
Scientific Advisor

Päivikki Hemmilä

Scientific Advisor
PhD

+358 45 120 0632 LinkedIn

Päivikki joined Medaffcon’s team in September 2017. She has a PhD in cancer biology. Päivikki has worked for the first 10 years of her career as a cancer researcher. After the research career, Päivikki has worked in different specialist positions in sales, research, quality and registration fields in pharmaceutical, medical device and CRO companies. Before joining Medaffcon, Päivikki worked in the Finnish Clinical Biobank Tampere, where she was responsible for the construction and development of the biobank’s quality system and operational processes.

Päivikki works as a scientific advisor in Medaffcon, where her extensive experience as a project leader, combined with strong scientific expertise, can be utilized in various client projects. Päivikki is fascinated by the continuous development of the healthcare industry as a result of cooperation between different actors. “It’s really interesting to see how the utilization of real-world data is evolving due to the possibility to access new data sources and due to the changes in legislation.”


Tanja Nieminen
Health Economist

Tanja Nieminen

Health Economist
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 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.” 


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 Tatu 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 optimal allocation of resources.”


Milla Summanen
Scientific Advisor

Milla Summanen

Scientific Advisor
PhD

+358 45 238 0122 LinkedIn

Milla started at Medaffcon in February 2019. Milla obtained her PhD in cell biology from Utrecht University in the Netherlands. From 2014 until 2019 she worked as a postdoctoral researcher at the Laboratory of Neurobiology at the University of Helsinki.

Milla’s strengths include a solid scientific background, excellent organizational skills, and a diverse and international educational background. Milla is especially interested in working with clinically relevant scientific data, in the possibilities of precision medicine, and in collaborating with the different stakeholders of the health care sector. “I believe that the importance of real-world evidence studies will increase, and the research results can be used to improve individual treatment paths in the future.”


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 on working with sensitive patient data, and strong interdisciplinary communication skills with experts from various fields. In the field, Iiro is particularly interested in the large data amounts opened with the revolution of technology and how the information received from the 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.”


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 in Statistics at the University of Helsinki specializing in bioinformatics in September 2018. Before joining Medaffcon, Samuli has 2 years’ worth of experience in research as a research assistant at the University of Helsinki, where he contributed to unravelling 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.”


Werneri Tuompo
Jr. Scientific Project Manager

Werneri Tuompo

Jr. Scientific Project Manager

+358 44 041 7670 LinkedIn

Werneri joined Medaffcon’s Medical team as a trainee in November 2017. He has a Bachelor of Science degree in Biomedicine. In addition to his work, Werneri is currently undertaking two different master’s degrees: Biomedicine and Wellness Technology. As a young employee, Werneri brings fresh perspectives from the university and applies them to practical work. In the field, he is interested in constantly changing circumstances, multi-professional working environment, and the possibilities digitalization offers when improving health.


Elisa Tyynysniemi
Scientific Project Manager

Elisa Tyynysniemi

Scientific Project Manager
M.Sc. (Pharmaceutical Science)

+358 40 839 4369 LinkedIn

Elisa started at Medaffcon in January 2015 as a Scientific Project Manager. Previously, Elisa has worked in drug safety unit at Novo Nordisk A/S in Copenhagen as well as sales permit related tasks in the Finnish Medicines Agency Fimea. Working at the Department of Pathology of the University of Turku, Elisa has also gained several years of experience in medical research and in working in a hospital environment.

Elisa has completed a Master’s degree in a programme for international drug development at the University of Copenhagen. She completed her Master’s thesis at Novo Nordisk A/S headquarters in Copenhagen. Elisa also holds a Bachelor of Science degree at the University of Turku in Biomedicine. Therefore, she has completed studies in Medicine, Natural Sciences, Pharmacy and Economics.

Due to her strong theoretical background and work experience, Elisa has wide understanding of the objectives of drug development both from the industrial and authority perspectives. Elisa is particularly interested in developing new medicinal treatment and improving therapeutic value. She is also excited about working with multifunctional teams and constructing seamless cooperation between different interest groups.