The clinical trials department is a contact place for clinical trials area (both external and internal leading),ensures all communication between FNUSA-ICRC and clinical trials sponsors and provides comprehensive services in a clinical trial realisation and introduction.
The FNUSA-ICRC Clinical Department takes care of the administrative aspects of the implementation of commercial clinical trials for the manufacturers and distributors of pharmaceuticals and medical devices within the entire St. Anne’s University Hospital.
Every year, the Clinical Trials Department helps launch 60 to 80 new commercial clinical trials and clinical assessments, so at any moment there are 160–180 clinical trials running at St. Anne’s University Hospital.
Clinical trials play an indispensable role in the development of new pharmaceuticals. Prior to registration and marketing, each new medicinal product must undergo several stages of development. A clinical trial involves assessing not only the safety and efficacy of the test drug, but also the adverse effects and effectiveness of the new medicine as compared to standard therapy.
Clinical trials in humans (phases I – IV) are subject to very strict rules and are conducted according to a pre-established plan. Before being administered to humans, the medicine must undergo standard preclinical testing, i.e. certain types of tests on cell cultures and animals. The sponsor of the trial must then obtain approval from the State Institute for Drug Control (SÚKL) and (at least one) ethics committee who carry out their assessments independently and, last but not least, the consent of the patient (i.e. informed consent) to whom the test drug will be administered. Assessing the trial involves examining all data from the preclinical trial and, if applicable, the clinical trial to-date, as presented in the documentation submitted by the sponsor of the trial. The quality of the drug and the conditions under which it its manufactured are also carefully evaluated. Each department or facility in which the trial is conducted must comply with the standards of good clinical practice.
Since 2009, the Clinical Trials Department has been the primary contact point for clinical trials. It is responsible for all communication between FNUSA-ICRC and sponsors of clinical trials or entities authorised by such sponsors.
Since 2013, FNUSA-ICRC has been a preferred partner of IQVIA (formerly Quintiles), a multinational company and the world’s largest Clinic Research Organisation. We collaborate with many other intermediaries and manufacturers of pharmaceuticals and medical devices. In 2017, we joined forces with other hospitals in Brno to form the Moravian Alliance for Clinical Trials. Together, we are able not only to carry out clinical trials on a larger number of patients but also to implement them in virtually any area of medicine.
To carry out phase I trials, the FNUSA-ICRC uses the Clinical-Pharmacological Unit where new pharmaceuticals and medical devices can be first tested on human volunteers.
For the testing and clinical assessment of diagnostic devices, we offer unique laboratories located in Faraday cages that provide shielding from virtually any electromagnetic signals from the outside. They are used for working with devices that work with a very weak electromagnetic signal, such as high-frequency ECG.
We also conduct academic clinical trials initiated by researchers who have developed a new drug or medical device. Within the Czech Clinical Research Infrastructure Network (CZECRIN) that supports academic clinical trials, we help other university hospitals in the Czech Republic to implement academic clinical trials.
• Preparing and maintaining a ‘feasibility study’ database for the given trial at the hospital.
• The start-up phase – communication with the outside sponsor of a trial, the principal investigator, and other collaborating departments and facilities such as the hospital pharmacy, laboratories or imaging department. As part of this phase, the department is also responsible for reviewing clinical trial agreements in legal and economic terms.
• Responsibility for billing during the clinical trial.
• Obtaining laboratory certificates and reference limits.
• Support for reimbursing patients’ travel expenses.
• Providing qualified trial coordinators who can assist with the administrative aspects of the trial directly at the clinics.
• Organising GCP training.
• Cooperation agreements with third-party institutions and facilities within the Czech Republic.
Initial agreement – required documentation
• Draft clinical trial agreement.
• Payment schedule.
• Clinical trial protocol with a flowchart and, where relevant, a summary of the protocol in the Czech language.
Negotiations process – required documentation
To negotiate an agreement, the following documents need to be provided:
1. Approval by the State Institute for Drug Control.
2. Approval by the Multi-Centre Ethics Committee/Local Ethics Committee.
3. Clinical trial insurance.
4. Extract from the Commercial Register (sponsor and CRO).
5. Power of attorney (if applicable).
1. Confirmation of notification to the State Institute for Drug Control.
2. Extract from the Commercial Register (sponsor and CRO).
3. Power of attorney (if applicable).
4. Approval by the Local Ethics Committee (if necessary).
• A clear reference to the exact billing and mailing address of the payer (sponsor/CRO) must be provided in the agreement.
• When paying invoices, the variable symbol = invoice number must always be indicated.
• Patients’ travel and other expenses may be reimbursed:
– In the form of meal vouchers/tickets from the sponsor,
– Through billing by the hospital and subsequent cash payment to patients via the FNUSA cash desk.
• At FNUSA, only a tripartite agreement between the sponsor (CRO), the principal investigator and FNUSA can be entered into.
• FNUSA prefers to receive draft agreements from sponsors, which are subsequently consulted in legal and economic terms.