Preclinical and Clinical Trial Requirements
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1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
No, there is no requirements for clinical trials to be conducted locally as a condition for marketing approval.
2. How are clinical trials funded?
Clinical trials are funded by the sponsors. The sponsor of a clinical trial can be a manufacturer, legal entity, or individual and is responsible for initiating, directing, ensuring quality, and financing the conduct of the clinical trial. Information on the financing of a clinical trial must be disclosed in the request for approval of a clinical trial, within the protocol or an agreement which is attached to the application.
3. What are the requirements for pre-clinical and clinical trial protocols? Who must approve the protocols?
The clinical trial protocol is a document that describes the objectives, design, methodology, statistical considerations, and organization of the clinical trial. It includes the protocol, protocol versions, and protocol amendments. The main required contents of the protocol are general information about the trial, basic information, objectives and purpose of the clinical trial, clinical trial plan, selection of participants, information on the treatment of participants, assessment of efficacy and safety, statistical data, information on direct access to source data or documents, data on quality control and assurance, ethical aspects of the clinical trial, information on data handling and documentation storage information, information on financing of the clinical trial and insurance of the participants, and method of publication of results in the clinical trial.
ALIMS and the Ethics Committee approve the protocol in the procedure for approval of a clinical trial, or within the scope of the procedure for amendment of the protocol.
4. What are the requirements for consent by participants in clinical trials?
The Medicines Act contains mandatory rules for obtaining trial subjects’ consent to participate as one of the conditions for conducting a clinical trial. Subjects, or their legal representatives, must be fully informed about the clinical trial and of their right to withdraw their consent to participate at any moment, in writing and in a language they can understand. Consent must be in written form, signed and dated. If a person is illiterate, they must give oral consent in the presence of at least one witness. Special provisions provide for the protection of minors and adults who are not able to give written consent to participation in clinical trials due to unconsciousness or physical or learning disability.
5. May participants in clinical trials be compensated?
No. Clinical trial participants may be reimbursed for their necessary expenses related to participation in the clinical trial. The information on the method of compensation for expenses must be included in the request for approval of the clinical trial and is assessed by the Ethics Committee.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
Prior to the commencement of a clinical trial, the sponsor of a clinical trial must insure the persons subjected to the clinical trial against personal injury, where the damage to health is caused by the clinical trial. When the clinical trial is conducted on children, the participants, or their parents or relatives, must not be inappropriately induced to participate in the trial in any way, including through compensation, so the compensation and the living expenses must be at the level of costs of a pediatric clinical trial. The compensation should be approved by the Ethics Committee.