At Forum’s professional meeting on the importance of clinical registries, held on 27 November 2018 at premises of Slovene Academy of Sciences and Arts in Ljubljana, various stakeholders in healthcare pointed out that clinical registries are key to improving treatment outcomes, researching and accepting evidence-based healthcare decisions.  It was estimated that the role of clinical registries in the process of evaluating health technologies and ensuring the financial sustainability of public health systems is invaluable and, in this context, drew attention to yet un-exploited potential of clinical registries in Slovenia and abroad. Since the establishment and proper functioning of clinical registries is an undisputed interest of all stakeholders in health, participants at the expert meeting organized by the International Forum of Scientific Research Pharmaceutical Companies in Slovenia agreed that the systemic regulation and further development of the area of clinical registries is necessary.

Different roles of clinical registries

Prof. dr. Petra Došenović Bonča from the Faculty of Economics of the University of Ljubljana, through the production function, demonstrated the multifaceted benefits of clinical registries for various stakeholders in health care. Well-established and functioning clinical registers enable health professionals to understand the disease and its development, the different ways and outcomes of treatment, and the factors of their variability. 

The clinical register also enables monitoring and understanding of time lags in patient response, more individualized treatment, and identification of factors leading to adverse events. Using clinical registries, it is easier to connect with experts of the same or related professions, and clinical registries also allow faster development of new professional guidelines for patient treatment. 

The role of clinical registries is also extremely important from the regulator point of view, and especially the payer of health services, since clinical registries contribute, among other things, to the easier identification of actual practices, such as the use of medical devices, and medicines.
Also important is the role that they have in assessing not only the clinical effects of individual services but also the cost-effectiveness of these services. Data from clinical registries can serve as a good basis for strategic consultation with health service providers, public reporting, development of education, and agreements with pharmaceutical companies to include new drugs on the lists. Clinical registries enable patients to better understand the disease and its development, risk factors and outcomes of treatment, and to manufacturers of medical devices, medicines and health technologies to better define actual consumption, to understand the differences in treatment outcomes of different population groups, better insight into cost-effectiveness and for agreements with payers of health services on the inclusion of medicines on the reimbursement lists based on treatment outcomes.

Untapped potential

Despite proven benefits for all stakeholders in health care, the development of clinical registries in Slovenia is cumbersome and the potential of clinical registries remains poorly used. Data from existing clinical registers are used for a very narrow set of purposes, although based on these data, health services could be developed towards more personalized medicine, deciding on a basket of rights, and the like. 

Existing clinical registries do not allow health professionals to provide up-to-date feedback, which could serve to accommodate patients' treatment, do not follow the trend of digitization and, among other things, do not allow linkages between individual organizations and countries and poorly integrate patients into the design, development and operation of registers. 

Cancer registry

The Cancer registry of the Republic of Slovenia was established in 1950 as a special service for the collection and processing of data on the incidence of cancer and the survival of cancer patients in Slovenia. The purpose of the registry is, according to the head of the RS Cancer Registry, prof. dr. Vesna Zadnik, primarily monitoring, planning and evaluation of oncological care and the basis for epidemiological and clinical studies. 

Data sources for the register are all national screening programs, administrative registries, national health databases, hospital register of the Oncology Institute Ljubljana, clinical and population research and public health institutions. In the Cancer Register of the Republic of Slovenia, patient identification data are collected, data on diseases and treatment, histological cytological diagnosis and vital state of patients. The National Cancer Control Program 2017-2020 is committed to expand the data set or to establish clinical registries for individual types of cancer, which would enable the preparation of indicators for evaluating the quality of treatment of oncological patients. Now, the Melanoma clinical register is already being tested, and the National Cancer Control Program 2017-2020 wants to establish, at least in the first stage, clinical registries for lung, colon, rectal, breast and prostate cancer.

Guidelines for setting up and maintaining registries

Head of the NIJZ Health Data Center, Metka Zaletel, highlighted several challenges that they face in the establishment and development of an organized collection and analysis system for data on groups of patients, those challenges existing also at European level. Patient registries are not always comparable and consistent, so data from different sources is poorly interconnected and unusable for secondary purposes. From 2012 to 2015, the National Institute of Public Health (NIJZ) led a joint European Parity Program (Patient Registries Initiative) to provide EU Member States with support in developing comparable and consistent patient registries in key areas such as chronic diseases, medical technology. In this process, guidelines and methodological recommendations for the efficient and rational management of patient registries were created. The head of the NIJZ data center pointed to the need for a national agreement on clinical registries, linking public health and clinical registries, clear definitions of the purpose of individual registry, and relevant regulatory bases that will allow comparability of patient registries in the national and European context.

In Slovenia are also good practices

Despite numerous challenges and inconsistencies in the field of clinical registries, we can also set up in Slovenia with individual good practices of clinical registries, which are primarily the result of the enthusiasm of groups of health professionals. A clinical register was established a decade ago at the Clinical Department of Rheumatology UKC Ljubljana. It is a register of patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis treated with biological medicines. The register, in which data is entered by all Slovenian rheumatologists, enables the standardization of effective and safe treatment in everyday clinical practice and serves as a research tool. Head of the Clinical Department of Rheumatology UKC Ljubljana prof. dr. Matija Tomšič explained that while maintaining a registry, that they want to upgrade with other groups of patients who are treated with expensive biological medicines, they are faced with various legal issues in the field of personal data protection. Nevertheless, he is convinced that clinical registries are necessary because they provide data on the efficacy and safety of individual treatment protocols to rheumatologists and represent a good source for research work.
In the last few years, Clinical Department of Pediatric Surgery and Intensive Care UKC Ljubljana has moved from paper to fully electronic business, which also led to EMRAM 6 certificates. Digital transformation, according to the pediatrician mag. Gorazd Kalan, supports clinical decision-making, remote access, research and assessment of clinical efficacy, and provides staff, time and financial savings.

At the Clinical Department of Hematology, UKC Ljubljana, in 2012, the Slovenian Register of Hematological Neoplasms was established, in which data on some of the most common hematological neoplasms were collected. The data in the register, which is owned by the Association of Hematologists of Slovenia, are entered in general hospitals, as well as in UKC Maribor and UKC Ljubljana. The purpose of the data analysis is to assess the incidence and prevalence of more frequent blood diseases, which allows planning of treatment and staffing needs, reporting of adverse events, and assessment of the quality of clinical work and analysis of the course of treatment. The register is useful for a more detailed assessment of diagnostic criteria and criteria for starting treatment and assessment of disease prognosis for individual patients, explained the head of the Clinical Department of Hematology UKC Ljubljana prof. dr. Samo Zver. Since certain medicines require special approval from the Commission of the Clinical Department of Hematology UKC Ljubljana, the register is also useful as a platform for the transmission of the application and approval of treatment by the commission.

Doc. dr. Sabina Škrgat from the University Clinic for Pulmonary Diseases and Allergy Golnik presented the international connection that Klinika Golnik joined in order to treat patients with severe asthma as effective as possible. It is an international network established by several German clinical centers of German Asthma Net E. V. and is combining data on patients with severe asthma. Since the number of patients with this type of disease in small centers is small, from the point of view of optimizing the diagnostic evaluation and treatment of patients with severe asthma, the integration of data into the common database is very useful.  In addition to Slovenia, Austria, Czech Republic and Switzerland joined the German international association, which aims to establish a clinical registry for patients with severe asthma.