On June 8, 2017, the 2nd national meeting of study nurses and clinical trial coordinators took place on the premises of the Medical Faculty of Masaryk University in Brno. The one-day conference was organized by the Masaryk Institute of Oncology with the support of the Medical Faculty of Masaryk University, the CZECRIN research infrastructure and the PharmAround endowment fund.
The conference was attended by 110 study nurses and coordinators from more than 20 leading workplaces from all over the Czech Republic, especially teaching hospitals, but also other medical facilities that conduct clinical trials of drugs, whether in oncology, neurology, rheumatology, diabetology or cardiovascular disease. The event met with a great response and was positively received. For many participants, this was the first opportunity of a joint professional meeting, which, however, has the ambition to become traditional.
The main topic of the meeting was the discussion on the position and agenda of this non-medical job position. The discussion revealed the need for its legal anchoring, precise definitions, increasing prestige and the related support for further education. The calls will be taken up by a working group composed of representatives of more than 10 medical facilities where clinical trials of new drugs are being conducted. They will promote the importance and responsibility of this profession not only to legislators, but also to hospital management, doctors, patients and the public. At the same time, faculty medical facilities launch up to a hundred new clinical trials a year.
Study nurses or study coordinators are an integral part of the clinical trial team. Their involvement facilitates the work of physicians and increases the quality of the study performed. Satisfied are also patients who are looking for not only information but also psychological support from the study nurse - coordinator during the entire course of the research. Nevertheless, this profession is often underestimated by medical facilities.
Prerequisites for the work of a study nurse as a clinical trial coordinator are, in addition to medical education, organizational skills, independence, knowledge of Good Clinical Practice (international rules for conducting clinical research), willingness to further education and knowledge of English in which most documentation is kept.
In Czech medical facilities, study nurses or coordinators work either within separate departments of clinical trials or directly at individual clinics and departments. Their role is to bring together representatives of the sponsor, doctors and patients. They help to find patients who can be offered to participate in the study, explain the course of the study, organize examinations and procedures according to the study protocol, can apply study treatment, provide biological material to central laboratories, collect and enter clinical data (patient course information), can participate in the evaluation of adverse events, sometimes they are in contact with ethics commissions and the State Institute for Drug Control, prepare the center for audits and inspections and, last but not least, provide all administrative activities.
Contact: Mgr. Michaela Hanáková, Department of Clinical Trials, Ministry of Interior, tel .: 54313 6226, 774 626 208
Ing. Andrea Křístková, coordinator of the PharmAround endowment fund, tel: +420 608 407 900
Mgr. Petra Srstková, marketing & media specialist, tel: +420 730 177 010
Clinical trial / clinical study: 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 Cancer 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 launches at least 20 new clinical trials each year. Each year, they enroll around 250 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 fact that it is the only representative of the Czech Republic in the Organization of European Cancer Institutes (OECI - Organization of European Cancer Insitutes) also testifies to the exceptional position of the institute.
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 15 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, and 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.