On June 6, 2019, the 4th nationwide meeting of study nurses and clinical trial coordinators will take place in the premises of the Medical Faculty of Masaryk University in Brno. The regular one-day conference is organized by the Masaryk Institute of Oncology with the support of the Faculty of Medicine of Masaryk University, CZECRIN research infrastructure, University Hospital at St. Anny - International Center for Clinical Research (ICRC) and PharmAround Endowment Fund.
Interest in this unique meeting is increasing every year. This year, almost 160 people from more than 30 workplaces from all over the Czech Republic registered at the conference, especially university hospitals, but also other medical workplaces that conduct clinical trials of drugs, whether in oncology, neurology, rheumatology, diabetology or cardiovascular diseases. Pharmaceutical companies, which are the main sponsors of clinical trials, are also represented among the participants. For the first time in the history of the conference, representatives of patients and patient organizations will also participate.
The conference program is divided into four blocks. The topic of the introductory part will be the profession of study nurse and coordinator. In the second block, the program will focus on the problem of increasing administration in clinical trials, which will be discussed in a panel discussion by representatives of clinical trial sponsors - pharmaceutical companies. The afternoon program is subtitled "Clinical Studies from the Other Side", where, among other things, two personal experiences of patients with clinical studies will be heard. At the end of the conference, the specifics of conducting clinical trials in private facilities are on the agenda, and representatives of the Alliance of Women with Breast Cancer patient organization will discuss the clarity of studies for patients.
Last but not least, the conference will, as always, be an opportunity to meet representatives of this young profession from all parts of the Czech Republic.
The conference partner is Novartis s.r.o.
Who is the study nurse - study coordinator?
The terms study or research nurse, or study coordinator, cover the work of a specialist in a clinical trial. The designation of the job position and the scope of work may vary from workplace to workplace, but in general it is most often a non-medical healthcare professional who provides a wide range of clinical trial activities, including patient education, organization of study participation, knowledge and procedures according to the study protocol. , collection of biological material and application of study treatment, collection and entry of data or all administrative support. Study nurses and coordinators significantly enable and facilitate the implementation of clinical trials and contribute to their quality. This is an interesting, albeit demanding and professional work in the development of a new drug, including a coordination and administrative agenda, as well as work with a patient enrolled in a clinical study.
The first independent department for the coordination of clinical trials was established at the Masaryk Cancer Institute in 2000 and today employs 14 qualified study nurses and coordinators. At present, they operate in various organizational variants in many medical facilities.
What are clinical trials? Clinical trials are an essential part of the life cycle of any drug before it is registered and placed on the market. Testing of a new drug is carried out in three basic phases (each lasting up to several years), especially its safety and efficacy. All clinical trials are approved by the State Institute for Drug Control and the relevant ethics committees. They take place in accordance with the legislation and principles of Good Clinical Practice. A patient / healthy volunteer can only be included in the study if all the criteria given in the protocol are met. He confirms his consent to participate in the clinical trial by signing the Informed Consent.
The tradition of conducting clinical studies at the Masaryk Oncology Institute dates back to the 1970s, when the institute was an important research partner of the pharmaceutical company Lachema in the field of the development of new cytostatics. However, in the last decade of the last century, the possibilities of clinical research have expanded significantly and the advent of the 21st century has brought a dramatic increase in the number of clinical trials. Currently, the MCI launchs approximately 20 new clinical trials each year. Each year, they enroll around 200 patients in clinical trials.
MCI belongs to the top and sought-after centers of clinical studies in the Czech Republic and the Central European region, where oncological clinical studies are performed at a high level.
Masaryk Cancer Institute The Masaryk Cancer Institute in Brno is a top specialized oncology center with supraregional scope, a unique medical facility in the Czech Republic. It concentrates all the necessary medical disciplines to provide comprehensive oncological care, which includes prevention, epidemiology, diagnostics, individual modalities of anticancer treatment, rehabilitation and education for the general public. It focuses on scientific research activities, including basic research. It is a workplace with pre - and postgraduate teaching of doctors and health professionals and with educational activities aimed at the general public. Every year, more than 10,000 patients are hospitalized in the institution and 163,000 people are treated in outpatient clinics.
The history of the Masaryk Cancer Institute dates back to the mid-1930s - it was ceremoniously opened in January 1935 - it is therefore the oldest oncology center in Central Europe.
At present, the MCI applies the latest procedures in internistic treatment, the most modern approaches are applied in the surgical treatment of cancer and in radiation - radiotherapy.
The exceptional position of the institute is also evidenced by the fact that it is the only representative of the Czech Republic in the Organization of European Oncology Institutes (OECI - Organization of European Cancer Insitutes).
CZECRIN is the Czech national research infrastructure supporting academic clinical trials, which connects teaching hospitals, universities and scientific centers in the field of biomedicine. It is the Czech national hub of the European Consortium of Clinical Research Infrastructures (ECRIN-ERIC). Their common goal is to support the development of academic clinical trials and to improve cooperation at the national and international levels. CZECRIN currently conducts more than 25 national and international academic clinical trials in many areas, including pediatrics and rare diseases.
The PharmAround Endowment Fund builds on the successful project of the Faculty of Medicine of Masaryk University. Its aim is to increase awareness and knowledge of drug life cycle issues through educational activities, especially in relation to clinical trials, pharmacovigilance or pharmacoeconomic aspects. The endowment fund organizes professional courses, workshops and conferences for doctors, teachers, researchers and students, supports independent projects in the field of biomedicine. It pays special attention to patient and public education and promotes an open independent exchange of views and experiences in the field of biomedicine.
Contact: Mgr. Michaela Hanáková Department of Clinical Trials, MCI michaela.hanakova@mou.cz phone: 54313 6226, 774 626 208
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