Preclinical and Clinical Trials
All legal aspects surrounding precinical and clinical trials in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, 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?
For the purpose of obtaining marketing approval, at least part of clinical trials should be conducted in Ukraine. Notably, in relation to medical products with well-established medicinal use within the EU and/or Ukraine, an applicant may provide references to published scientific data instead of conducting clinical trials and submitting their results to the State Expert Center (“Center”) for obtaining marketing authorization.
2. How are clinical trials funded?
According to Article 24 of the Law of Ukraine “On Medicinal Products”, clinical trials may be funded from state or local budgets, by legal entities, organizations, institutions or individuals, as well as from other sources not prohibited by Ukrainian law. Legal entity or individual that is responsible for initiation, organization and/or funding the clinical trials is considered a sponsor.
Funding of clinical trials is also regulated by the Procedure on Conducting Clinical Trials of Medicinal Products and Examination of the Materials of the Clinical Trials approved by Order No. 690 of the Ministry of Health of Ukraine (“Ministry”) dated 23 September 2009 (“Clinical Trials Procedure”).
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
According to the Procedure on Conducting Preclinical Trials of Medicinal Products and Examination of the Materials of the Preclinical Trials approved by Order No. 944 of the Ministry dated 14 December 2009, preclinical trial protocol determines the objectives and design of the preclinical trial and shall include the following sections:
- General information, including the name of the trial, objectives and characteristics etc.;
- Information regarding the sponsor and executors of the trials, as well as engaged investigators;
- Dates of approval and alignment of the protocol, period of the trial; and
- Trial design.
The above list is not exhaustive. The preclinical trial protocol may be supplemented with other information that the applicant deems reasonable to provide.
The preclinical trial protocol should be approved (signed, dated) by the clinical trial manager and reviewed for compliance with the Good Laboratory Practice (GLP). The protocol should be further approved by the head of medical institution involved in the trial and by the sponsor.
According to the Clinical Trials Procedure, clinical trial protocol should describe the objectives, methodology, procedures, statistical considerations, and design of the clinical trial, as well as, as a rule, justification for a trial. The Clinical Trials Procedure sets out that the trial protocol shall include information as provided by Section 6 of the Good Clinical Practice (GCP), in particular:
- General information about all participants of a trial (name, address, contact information);
- Background information (name and description of the investigational product, description of the population to be studied, references to nonclinical studies, literature, and data that are relevant to the trial);
- Trial objectives and purpose;
- Trial design;
- Selection and withdrawal of subjects (subject inclusion/exclusion criteria);
- Treatment of subjects;
- Assessment of efficacy;
- Assessment of safety;
- Direct access to source data/documents;
- Quality control and quality assurance;
- Data handling and record keeping;
- Financing and Insurance;
- Publication policy; and
Clinical trial protocols along with other materials of the clinical trial are subject to expert examination at the Center of the Ministry. Following examination of trial materials, the Center gives either a positive or a negative opinion on conducting the trial. The Center’s opinion must be further approved by the Ministry.
4. What are the requirements for consent by participants in clinical trials?
Clinical trials are conducted with an adult patient (volunteer), who is legally capable subject to his written consent to participate in such trials (so-called “informed consent”). Special consent requirements should be met with respect to the participation of minors in clinical trials:
- involving a minor (individual under 18) requires the written consent of both parents and providing the minor with written and oral information regarding the trial in understandable form;
- in cases involving an individual aged between 14 and 18, his/her written consent should be obtained in addition to parents’ consent.
Clinical trials with a person who is recognized as incapable or whose civil capacity is limited due to mental illness can be performed only under the written consent of legal representatives of such person.
The Clinical Trials Procedure provides for mandatory list of written and oral information to be provided to the patient (volunteer) in understandable form for obtaining his/her consent (e.g. nature of clinical trial, procedures, implications, risks, rights and obligations of the trial subject, compensations, insurance information, etc.). The consent should be dated, signed, evidence of trial subject’s awareness of all information to be provided to him or her under the Clinical Trials Procedure, as well as indicate that it was given freely after receiving the information in full. The consent to participate in the clinical trial must include consent of the patient (volunteer) or, where applicable, their legal representative or close relative, to processing his/her personal data.
If the individual is unable to write, his/her oral consent may be obtained in the presence of at least one witness who confirms the trial subject’s consent in writing.
5. May participants in clinical trials be compensated?
Generally, it is not prohibited to provide compensation to clinical trial participants. However, the Clinical Trials Procedure prohibits using any encouragement or inducement in relation to engaging minors and incapable persons in clinical trials, except for providing them indemnification against health harm caused by the trial.
Besides monetary compensation (which is rarely practiced), the participants may be reimbursed for their travel expenses, meals, and compatible expenses.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
As a matter of law, participants in clinical trials shall be insured against trial-related injuries. Concluding an insurance agreement between sponsor and insurance company is one of the condition precedents to obtain approval for clinical trials.
In the event of trial-related injury, the participants shall obtain compensation and/or treatment pursuant to the terms of the respective insurance certificate. Notably, when obtaining a participant’s informed consent for participation in a trial, the sponsor should ensure that the participant is given details of the insurance agreement, as well as provided with details of the insurance company.