What is a clinical trial?

  • A clinical trial (“CT”) is a study involving human subjects, conducted to identify or confirm the safety and effectiveness of means, methods, and technologies for the prevention, diagnosis, and treatment of diseases.

What types of CTs are there?

  • A non-interventional CT is a study which is conducted after the state registration of a medicine or medical device (“MD”) and is prescribed as part of medical practice.
  • An interventional trial is a study involving a human subject in which a researcher-physician assigns a specific intervention to the subjects based on an interventional CT protocol which complies with the CT procedure.

Is a notification/permission required to conduct clinical trials?

  • To conduct an interventional CT of a medicine, it is necessary to obtain a permission from the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the Republic of Kazakhstan.
  • Before obtaining the permission, it is necessary to obtain a conclusion on the results of the examination of the CT materials from the National Center for Expertise of Medicines and MDs, as well as a conclusion on the results of the bioethical examination of the CT materials from the Central or Local Bioethics Commission.
  • For non-interventional CT notification is required.
  • For non-interventional CT, it is necessary to obtain a conclusion based on the results of a bioethical examination of the CT materials from the Central or Local Bioethics Commission.

In the Republic of Kazakhstan (“RK”), the main legal acts regulating CT are:

  • The Code of the RK dated July 7, 2020 No. 360-VI “On Public Health and the Healthcare System”
  • Defines the legal bases for regulating and conducting CT of Medicines, MDs, and clinical laboratory tests of MDs for diagnostics outside a living organism (in vitro).
  • Rules of Good Clinical Practice of the Eurasian Economic Union, approved by the Decision of the Council of the Eurasian Economic Commission of November 3, 2016 No. 79
  • Establish international ethical and scientific standards for planning and conducting studies involving human subjects, as well as for the documentation and presentation of the results of these studies.
  • The Standard of Good Clinical Practice (GCP), approved by the Order of the acting Minister of Healthcare of the RK dated February 4, 2021, No. ҚР ДСМ-15)
  • Establishes rules for conducting studies involving human subjects, as well as for the documentation and presentation of the results of these studies.
  • ISO 14155:2014, Recommendation of the Board of the Eurasian Economic Commission of September 4, 2017, No. 17: CT of MDs involving human subjects. Good clinical practice.
  • Establishes provisions for good clinical practice for the planning, conduct, documentation, and reporting of results of CT involving human subjects to evaluate the safety or performance of MDs.
  • Rules for Сonducting СT of Medicines and MDs for In Vitro Diagnostics and Requirements for Clinical Sites and for the Provision of the Public Service “Issuance of Permission to Conduct CT and/or Testing of Pharmacological and Medicinal Products, MDs, approved by order of the Minister of Healthcare of the RK dated December 11, 2020 No. ҚР ДСМ-248/2020
  • Establish the procedure for conducting CTs of Medicines and MDs, clinical laboratory tests of MDs for diagnostics outside a living organism (in vitro) and requirements for clinical bases.

Key regulatory bodies

Ministry of Healthcare of the RK

The Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the RK

  • Issues permission to conduct CT and/or testing of pharmacological and medicinal products, MDs;
  • Conducts CT inspections.

National Center for Expertise of Medicines and MDs

  • Conducts an examination of CT materials and issues a conclusion on the conduct of CT.

Central Commission on Bioethics

  • Conducts a bioethical examination of CT materials and issues opinions on the conduct of interventional CT of foreign-produced medicines and MDs, as well as interventional and non-interventional CTs of Medicines and MDs conducted in two or more research centers located in the territory of the RK.

Local Bioethics Commission

Conducts a bioethical examination of materials of single-center interventional and non-interventional CTs, with the exception of cases of interventional CTs of Medicines and MDs produced outside the RK.

What are the requirements for clinical sites?

  • The requirements for clinical sites:
  • availability of a license to carry out medical activities;
  • availability of standard operating procedures for conducting CTs;
  • availability of clinical, instrumental and laboratory equipment for conducting CTs or availability of contracts with contractors for the provision of specialized clinical, instrumental, laboratory and auxiliary services for conducting CTs (in the absence of the necessary equipment);
  • availability of personnel with medical education and a GCP training document;
  • availability of conditions for intensive care and resuscitation (if required by protocol);
  • availability of a document establishing the procedure for working with confidential information.
  • GCP and ISO14155:2014 standards set more detailed requirements for clinical sites.

Are there any CT inspections in the RK?

  • Inspections are carried out by the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the RK in accordance with the Rules for Conducting Pharmaceutical Inspections on Good Pharmaceutical Practices, approved by Order No. ҚР ДСМ-9 of the Minister of Healthcare of the RK dated January 27, 2021.
  • The objectives of the inspection are the following:
  • assessment of compliance with GCP and ISO 14155:2014 standards;
  • confirmation of compliance of the CT with the approved CT protocol;
  • confirmation of the reliability of the data obtained as a result of CTs;
  • investigation of complaints (signals) received with regard to the CT, as well as upon receipt of additional information about the risk associated with conducting the CT;
  • protection of the rights, health and well-being of the subjects of CTs.
  • Inspection is carried out at any stage of the CT in a planned (primary) or unscheduled manner (including in connection with a threat or harm to the life or health of trial subjects).
  • The Ministry of Healthcare of the RK, based on the inspection data, makes a decision on:
  • termination of CT;
  • recognize the results of the CT.

What are the requirements for participation in the CT?

  • The need to obtain informed consent:. Before inclusion in the CT, the trial subject or their legal representative shall receive the information about the planned CT, on the basis of which the trial subject or their legal representative signs the informed consent for voluntary participation in the trial.
  • Restrictions on participation in CTs for certain categories of persons: CTs of medicines and MDs on minors, pregnant women, incapacitated individuals, students, pensioners, and those requiring assistance are conducted only to study the therapeutic effect and with the consent of a relative, guardian, or parent.
  • Prohibition of participation in CTs for certain categories of persons: interventional CTs on military, law enforcement and special government agencies’ personnel, employees of medical organizations where biomedical research is conducted, and persons held in penal institutions are prohibited.

What constitutes the result of the CT?

  • The result of the CT is the final report on the conducted CT of medicines and MDs, regardless of whether the trial was completed or terminated early.
  • No later than 1 year after the full completion of the CT (in case of international CTs, after the completion of the CTs in all countries), the sponsor provides brief information about the CT to the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the RK and the Central Bioethics Commission which issued the permission to conduct the CT.
  • The sponsor and the investigator archive the materials (documents) of the CTs and ensure their safety for 25 years from the date of completion of the CT.

As of the publication date of this alert, the draft regulations on CT are under public discussion; therefore, further amendments may be introduced.

 

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