Preclinical and Clinical Trial Requirements
All about preclinical and clinical trial requirements in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
Under the EAEU regulations, clinical trials are to be conducted in the EAEU in compliance with the Good Clinical Practice of the EAEU (approved by the decision of the Council of the Eurasian Economic Commission dd 03.11.2016 No. 79).
2. How are clinical trials funded?
Subject to Art. 42 of the Law on Circulation of Drugs clinical trials may be funded with budgetary funds, funds of the developer of the drug, and other sources. The EAEU regulations do not include any specific provisions on this issue.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
Preclinical data shall be collected to justify whether clinical trials can be conducted and are subject to the EAEU Good Laboratory Practice. The developer of the medical product shall maintain the study plan (protocol) of such preclinical trials. The study plan (protocol) for preclinical trials must include the main objectives, methodology, procedures, statistical aspects, organization, and resource planning of the preclinical trial (including its stages and parts), as well as measures to ensure the security of the systems involved. The study plan must be approved by the director of studies, test facility management, and sponsor of the trial, if this is required by the legislation of the member states of the EAEU or the legislation of the member state where the preclinical trial is conducted.
Clinical trial protocols must describe the objectives, design, methodology, statistical methods, and organization of the trial subject to the EAEU Good Clinical Practice. In addition, the clinical trial protocol usually contains previously obtained data and the rationale for the trial. The clinical trial protocol must be approved by the Institutional Review Board (Independent Ethics Committee).
Essentially, clinical trials are subject to ethical guidelines, rights, and welfare of human beings.
4. What are the requirements for consent by participants in clinical trials?
Participation of a patient in a clinical trial shall be voluntary and subject to his/her written informed consent that may be revoked.
5. May participants in clinical trials be compensated?
Under the EAEU Good Clinical Practice, participants may be compensated.
The Institutional Review Board (Independent Ethics Committee) reviews the amount and procedure of payments to the participants to ensure that there is no unreasonable interest or coercion of the participants. The number of payments to participants may be proportional to their participation in the trial but should not depend solely on whether the subject has fully completed the study or not.
Besides, the Institutional Review Board (Independent Ethics Committee) must ensure that the information about payments to participants, including the methods, amount, and procedure for payments, is reflected in the written informed consent and any other materials provided to the participants. The procedure for determining the amount of payments must be specified.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The risks of the participants shall be subject to compulsory insurance, as provided by Art. 44 of the Law on Circulation of Drugs. The minimum value of compensation in case of occurrence of each type is stated by the law.