Preclinical & Clinical Trial Requirements
Preclinical and clinical trial requirements in Slovakian Pharma – a legal guide. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
No, clinical trials can also be conducted abroad. If the clinical trial is performed outside the EEA, the applicant for the marketing approval must submit a declaration that the clinical trial performed outside the EEA meets the ethical requirements as required by the Act on Medicinal Products.
2. How are clinical trials funded?
In the Slovak Republic, clinical trials are generally funded by sponsors from the pharmaceutical industry. According to the Act on Medicinal Products, the sponsor is an individual or a legal person who manages and finances the clinical trials. The sponsor can be represented in the matters connected with the clinical trial on the basis of a power of attorney by an individual or a legal person (the Representative, usually a contract research organization); nevertheless, the sponsor remains responsible for the performance of the clinical trial in line with the Act on Medicinal Products. The sponsor or its Representative must have a residency (in case of an individual) or its registered seat (in case of a legal person) in an EU member state.
The financing arrangements of the clinical trial are generally regulated in a separate agreement between the sponsor and the investigator.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
According to the Act on Medicinal Products, a clinical trial shall be conducted according to a trial protocol which contains the following:
- objectives and design of the clinical trial;
- criteria for inclusion of the participants in the clinical trial and their exclusion from the clinical trial;
- methodology of monitoring and managing the clinical trial;
- requirements for storage and handling of the investigational medicinal product;
- methodology of the statistical evaluation and manner of publishing the generated results;
- the approved protocol modifications; and
- the data about the investigator.
The trail protocol must be prepared in line with the requirements of the Guideline for good clinical practice (ICH) and the trail protocol itself must contain a declaration that the clinical trial will be conducted in line with this guideline.
The trail protocol (among other documents) must be submitted to and approved by the respective Ethics Committee and the State Institute for Drug Control. In order to obtain an approval of the State Institute for Drug Control, the respective Ethics Committee must issue a positive opinion to the clinical trial.
4. What are the requirements for consent by participants in clinical trials?
The participants in a clinical trial should be firstly thoroughly advised on the scope, nature, consequences and risks of the clinical trial. The advice must be given clearly and in suitable language and the participants must be given sufficient time in order to freely decide to give their consent. The informed consent must be in writing, dated and signed by the participant capable of giving his/her consent. If the participant is not capable of giving his/her consent, the informed consent must be signed by the legally designed representative of the participant. If the participant is capable of giving his/her consent, however, he/she is incapable of writing, he/she can give his/her consent orally into a deed in the presence of at least one witness who will sign this deed.
The information for the participants must contain, among other matters, the following:
- information on the clinical trial and its objectives;
- possible benefit of the clinical trial to the participant;
- possible risks and disadvantages of the clinical trial to the participant;
- advice on other treatment possibilities;
- provision for confidentiality of personal data;
- information on the rights of the participant;
- information on possibility of the participant to withdraw from the clinical trial at any moment and on manner and consequences of possible interruption of the clinical trial;
- information on compensation of the participant;
- measures for providing for an adequate compensation in case of damage to the health of the participant in connection with his/her participation in the clinical trial;
- sources of financing of the clinical trial;
- opinion of the Ethics Committee.
Additional requirements apply on minors, and adults who are incapable of exercising legal acts.
5. May participants in clinical trials be compensated?
In Slovakia, the participants in the clinical trials may be compensated. The information on their compensation (including the amount, the manner, and the payment schedule) or reimbursement of expenses should be included in the informed consent to be signed by each participant in the clinical trial. This information should be, however, formulated in a non-motivating manner. The compensation should be paid out in portions, and not as a lump sum paid out at the end of the clinical trial. In addition, the sponsor is obliged to pay all expenses connected with the clinical trial, including all expenses for the examinations and therapies as specified in the protocol.
When reviewing the application for the opinion to the clinical trial, the respective Ethics Committee observes also the arrangement on the compensation or reimbursement of expenses to be provided to the participants. It also reviews whether it does not represent a pressure on the participants or their unreasonable influencing.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The statutory condition for conducting a clinical trial is the existence of the insurance policy covering the civil liability insurance for damage caused to the participant concluded by the healthcare provider.
According to the Act on Medicinal Products, the sponsor bears all expenses connected with the conclusion of this insurance policy. Also, when reviewing the application for the opinion to the clinical trial, the respective Ethics Committee observes also the insurance policy covering the liability insurance for damage concluded by the sponsor, if the health of the participant is damaged or if the participant dies in connection with the clinical trial. Generally, the insurance does not cover claims of the investigator caused as a result of its unprofessional treatment or negligence, or claims of the investigator or the participant caused as a result of their acting at variance with the protocol.
In addition, the sponsor is obliged to reimburse all expenses related to the treatment of health complications and possible permanent consequences on the health of the participant caused as a result of the clinical trial.