Повышение доступности и открытости информации по проводимым биомедицинским исследованиям в Республике Казахстан на основе разработки и запуска Национального регистра биомедицинских исследований: Аналитический обзор для формирования политики

Abstract

What is the problem? • Lack of culture and legal grounds for providing open and full access to information on biomedical research (BMR) conducted in the territory of the Republic of Kazakhstan. • Lack of a unified on-line platform that provides the ability to search for specified parameters and extract information in full-text format and in an accessible language about completed and ongoing BMRs. • Low availability of information about BMR held in the territory of the Republic of Kazakhstan for the scientific and professional medical community, health policy makers and the population. Policy options Option 1. Creation of a legal basis for registration of BMR in a unified national register, providing open and full access to information about BMR held on the territory of the Republic of Kazakhstan, by: o Securing the requirement for mandatory registration of BMR in the National BMR Register in the regulatory legal acts, which determine the procedure for conducting BMR, preclinical trials (PCT) and clinical trials (CT) of drugs and medical devices; o Inclusion of the requirement for mandatory registration in the National BMR Register in contracts concluded with scientific, sociological and analytical performers in the field of health care; o The conclusion by the Ministry of Health of an agreement with the editors of scientific journals published in the territory of the Republic of Kazakhstan that all published results of BMR can be published when the BMR data is included in the National BMR Register and (or) an authoritative international register. o Elaboration of mechanisms for retrospective filling of the National BMR Register by organizations that conducted BMR in the last 10 years. Option 2. Development and launch of an online resource of the National BMR Register, which provides access for various groups of users and provides automation of the processes of registering BMR, search and analysis of information contained in the register by: o Creation of an online resource of the National BMR Register in accordance with the recommendations of the ICMJE, with filling in all data included in the authoritative registers of the CT (for example, ClinicalTrials.gov), PCT (for example, PreclinicalTrials.eu) and other registers of the BMR providing free (on state, Russian, English) and full-text access to all registered BMR; o Development of instructions for maintaining the National BMR Register, training modules on working with the register, conducting a wide information campaign among all interested parties; o Development of on-line platform for the Unified system for submitting applications for CT in integration with the National BMR Register (functioning on the principle of a “single window” for licensing procedures, information support, reporting, etc.); o The institutionalization of the mechanism of the Unified system for submitting applications for CTs by forming a Coordination Center for Clinical Trials and fixing a new mechanism for accepting applications in the Rules for conducting clinical trials of medicines and medical devices. • Option 3. Development of international cooperation in the field of BMR registration, by: o Submission of an application for the inclusion of the National BMR Register as a primary register in ICTRP (sending to WHO a profile and technical questionnaire, letters of support from the Ministry of Health of the Republic of Kazakhstan); o Ensuring regular transmission of data from the National BMR Register to ICTRP; o Development of the practice of registration of BMRs conducted on the territory of the Republic of Kazakhstan in international registries (ClinicalTrials.gov, PreclinicalTrials.eu, etc.). Vision on the implementation of policy options In assessing the feasibility of implementing the proposed policy options, taking into account the existing barriers and opportunities, we conclude that all three policy options complement each other. However, given the differences in options in the direction of actions, the resources and methods used, these policy options can give a more significant achievement of the goal of increasing the availability and openness of information on the conducted BMR in the Republic of Kazakhstan when they are combined.