eClinicalMedicine, Volume 58, April 2023
Authors: E.A. Voss, et al - incl. Clinerion's Barış Erdoğan
https://doi.org/10.1016/j.eclinm.2023.101932

Since coronavirus disease 2019 (COVID-19) was first reported until July 2022, over 554 million cases and 6.3 million deaths have been reported worldwide. COVID-19 vaccines have demonstrated to reduce COVID-19 hospitalisations and deaths, both in randomised controlled trials and in real-world observational studies. As of 30th May 2022, more than 5 billion people (approximately 67% of the global population) have received at least one dose of a COVID-19 vaccine. At least 39 vaccines have been authorised or approved for use by at least one country, of which 11 have been granted emergency use by the World Health Organization (WHO). Although vaccine safety has been rigorously monitored in clinical trials, rare adverse events can go undetected during vaccine development due to limited number of trial participants, a relatively short follow-up duration, and insufficient generalisability to the broader population ...

Link to the paper in eClinicalMedicine >

January, 2023

Accessing and understanding data quality, as well as the extent and depth of coverage, is critical to understanding and finding data which is “fit for purpose,” and therefore able to address the questions of interest in research. 

Our new white paper outlines the capabilities of Clinerion’s Patient Network Explorer platform as a RWD resource, important to understanding disease incidence, medication use, standards of patient care and HEOR metrics. The paper analyses oncology metrics from the RWD in the platform’s global, federated EHR network and compares them to WHO-reported statistics through the Global Cancer Observatory. Patient cohort analytics can also be developed using Patient Network Explorer to illustrate most-common co-morbidities, medications, treatments and procedures for a target disease population.

The white paper illustrates how Patient Network Explorer’s RWD matches global disease incidence statistics, allowing study of specific patient cohorts to understand contributing diseases, standards of care, drug regiments and outcomes based research across sites in Clinerion’s network.

Access the White Paper >

November, 2022

By M. Alexander, H. Matthews, D. Drake, S. Beecroft

In association with OPEN Health.

Over the past decade, there has been a substantial increase in the acceptance of real-world evidence, further amplified with the COVID-19 pandemic. This has led to an increase in observational multi-country studies, allowing for the generalisability of real-world findings beyond specific geographic borders.

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November, 2022

In association with Roche.

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In this study, it was aimed to identify patients of Gaucher disease by modeling the phenotypes specific to the disease among the patients diagnosed with the ICD10 code "E75.2" in the electronic health records (EHR) of Istanbul Faculty of Medicine Hospital.

This poster was originally presented at SSIEM 2022.

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Fabry disease, which may begin in early childhood with sign of a medical problem and symptoms, and can cause renal, cardiac and cerebrovascular complications and organ failure is a progessive, multisystemic, inherited lysosomal storage disorder (LDH). It is observed in approximately 1 in 6,000 live births.

The disease spectrum is heterogeneous, progressive, and clinical phenotypes are wide. Fabry disease may cause premature death in adulthood. Diagnostic delays of approximately 15 years have been reported. Early symptoms and diagnosis at a potentially reversible stage of the disease are important.  In patients with Fabry disease, life expectancy is reduced by about 15 to 20 years in men and about 6 to 10 years in women.

In this study, it is aimed to detect Fabry patients by using electronic health record (EHR) data in the Hospital of the Faculty of Medicine of Istanbul University.

Download the report >

It is predicted that the number of individuals with diabetes in the world will increase 55% to reach 592 million in 2035 while this number is 382 million as of 2013.

Atherosclerotic cardiovascular disease (ASCVD) is one of the most important occurrences of morbidity and mortality in patients with diabetes.

In this study, which has been designed with a single-center, retrospective research design, using electronic health record (EHR) data; it is aimed to detect the co-occurrence rates of T2DM and risk factors with real-life data.

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Pompe disease is a lysosomal storage disorder that progresses with the accumulation of glycogen in the lysosome. 

In this study, it is aimed to detect Pompe patients by using electronic health records (EHR) data.

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A Top 20 pharma company had initiated a trial for a new medication for Crohn’s Disease in 2016, with the goal to complete recruitment by mid-2021 in the USA. However, the trial had not met recruitment goals for the combined phase 3, double-blind, randomized, placebo-controlled study by May 2020.

Our Case Study outlines how Clinerion was able to support them in completing their recruitment goals.

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June, 2022

TTR-FAP disease is an adult-onset severe autosomal dominant hereditary neuropathy. This study was planned to understand the epidemiology of TTR-FAP among patients who applied to Konya Selçuk University, and to determine the geographical distribution of this disease at local level data of province in RWE concept.

With this research, it was aimed to increase the awareness of clinicians in Turkey about TTR-FAP disease and to obtain epidemiological data of TTR-FAP patients in Turkey.

This RWE study was designed as a retrospective, single-center, longitudinal descriptive study; and aims to assess geographical distribution of probable TTR-FAP cases, where country-level epidemiological data is limited. Real-world data obtained from routine clinical practices at Selçuk University Hospital, between the years 2009 and 2018, in Konya province in Turkey were analyzed. The data was collected from HIMS in accordance with the Clinerion data structure.

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June, 2022

Preliminary findings of a project on identifying undiagnosed Fabry patients using a disease-specific phenotypes model which we developed together with project partners from academia and the pharmaceutical industry.

Project by Sinan Fındık with Istanbul University Medical Faculty & Sanofi, presented at the 20th Çukurova Pediatrics Congress, Adana, Türkiye, in June, 2022 (in Turkish)

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June, 2022

Preliminary findings of a project on identifying undiagnosed Pompe patients using a disease-specific phenotypes model which we developed together with project partners from academia and the pharmaceutical industry.

Project by Sinan Fındık with Istanbul University Medical Faculty & Sanofi, presented at the XVI. International Metabolic Disorders and Nutrition Congress, Hatay, Türkiye, in May, 2022 (in Turkish).

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May, 2022

Evaluation of the distribution of patients with atherosclerotic cardiovascular diseas​e (ASKVD) and ASKVD risk factors among individuals with type 2 diabetes (T2DM) using electronic health record (EHR) data: A single-center retrospective real-life data (RWD) in Türkiye

Project by Sinan Fındık, with İnönü University & AstraZeneca, presented at the 43rd Endocrinology and Metabolic Diseases Congress, Antalya, Türkiye.

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April, 2022

Alleviating the suffering of rare disease patients caused by incorrect diagnosis through use of Clinerion’s Patient Network Explorer, global patient data network and AI/ML technologies.

Rare diseases, by nature of being rare, often go undiagnosed or are misdiagnosed, and for these reasons, rare disease patients may not receive the right treatment. For many rare diseases – and there are currently more than 6,000 – there is strong evidence that at least 50% of patients are never correctly diagnosed due to heterogeneous presentation, lack of medical expertise in recognizing symptoms and limited access to the specific diagnostic tests required. Rare diseases often present with different symptoms, which can cause a significant delay in diagnosis; this situation affects not only the patient, but also the family, health care providers and social support structure.

This white paper presents Clinerion's work on identifying undiagnosed rare disease patients by modelling disease-specific phenotypes through use of Clinerion’s Patient Network Explorer, global patient EHR network and AI/ML technologies.

Access the White Paper >

February, 2022

Did you know that Clinerion has significant coverage in Poland? We recently contributed to the report "Industry Clinical Trials in Poland."

"Industry Clinical Trials in Poland. Possibilities to increase number and scope of trials in Poland." is a report sponsored by the Polish Association of Innovative Pharmaceutical Companies (INFARMA) and the Polish Association for Employers of Contract Research Organizations (POLCRO). Clinerion was invited to contribute a chapter on "Harnessing the Power of Electronic Health Records to Increase Speed and Precision of Clinical Trials."

Download the report here (page is in Polish, but an English language report is available) >

February, 2022

Everything you need to know about clinical research & healthcare digitalization in the Middle East & Turkey: read our chapter, by Barış Erdoğan and Le Vin Chin, in the new book on the challenges & solutions of Clinical Research at MENA, by Fatih Özdener!

"The meaning of Clinical Trials for humans has recently changed significantly, “evolved”, so to speak. In today’s environment, where ethical validity is much more strictly controlled, this meaning is far beyond “human drug testing” and much closer to the “therapeutic goal”. The number of clinical trials in western countries that have perceived this change has increased rapidly and continues to increase. Although the number of clinical studies in the MENA region is increasing day by day, it is still far from its potential. Among the reasons for this are legal, technological, ethical, epidemiological, educational and economic factors. This book presents both the difficulties encountered in conducting clinical trials in MENA and
suggestions for solving these difficulties."

Fatih Özdener has broad pharmaceutical industry experience at different local and regional medical functions including clinical operations, clinical quality and medical management in Turkey, Middle East and Africa. He has more than twenty publications in the fields of molecular and clinical pharmacology. Currently, he is a faculty member and a member of management board at Bahcesehir University School of Medicine and the program coordinator of Pharmaceutical Medicine master’s degree program at the same university.

More details and ordering >

October, 2021

Enabling a full digital patient profile from EHR to enhance physician access, clinical research, and patient care.

As the volume of both clinical trial and real-world data continues to grow exponentially, the pharma industry is struggling to deal with data interoperability issues and generate actionable insights. There is a critical need to address concerns around data standardization, data security, data ownership and to build robust data governance models to enable data integration.

This white paper presents Clinerion's vision for the future of technology for real-world data insights, addressing these topics and also touching upon evolving models such as data fabrics, federated learning platforms and digital ecosystems.

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July, 2021

Clinerion’s Patient Network Explorer offers indication-agnostic access to live, real-world, anonymized, aggregate EHR data of its partner hospitals.

More details and example reports on Multiple Myeloma in Turkey & Asthma, FeNO ≥20 ppb in the UAE >

June, 2021

Our work with our partner Datametrix uncovers how use of statistical analytics methodologies on electronic health records can build synthetic control arms to supplement clinical trial data for better clinical and regulatory decisions.

Find out more and access the poster >

April, 2021

Strategies Toward Identifying Undiagnosed Rare Disease Patients

In this poster, produced together with Volv Global and originally presented at the Frontiers in Pediatric Genomic Medicine Conference (April, 2021), we explore how EHR-based real world data enables the ability to find potential patients that have been diagnosed as well as those that have not been correctly diagnosed.

The poster explains how EHR systems can be used to identify existing diagnosed patients, to identify undiagnosed patients through related symptoms, and to model more heterogenous disease response using an AI/ ML approach to find patients yet undiagnosed.

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September, 2020

The poster explains how Clinerion’s ecosystem allows the interrogation of retrospective data, as well as the generation of new prospective data for RWE studies, surveillance, sentinel and cross-sectional studies, feasibility studies, screening for risk management or health-care system evaluation, among other traditional or innovative study designs.

Download the poster >