ANALYSIS OF THE CURRENT SITUATION ON THE AVAILABILITY OF INFORMATION ON ONGOING CLINICAL TRIALS IN THE REPUBLIC OF KAZAKHSTAN
Availability of information about clinical trials (CTs) in the country is an important condition for sufficient transparency and quality of CTs. The purpose of this study was to analyze the availability of information about CTs in Kazakhstan. The main method was searching among publicly available sources on the internet. Data from four sources were found and analyzed: two Russian-language ones – the National Database of CTs of the National Center for Expertise of Medicines and Medical Devices and the Russian Federation Register “State Register of Medicines” with data on CTs in Kazakhstan; two English-language ones - the International Clinical Trials Database of the US National Library of Medicine ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). Data from local ethical commissions were also taken into account. Based on the results of the analysis, the following main conclusions were made: English-language databases were more accessible and informative; the amount of information and its content was different in all four resources; all four resources had missing data. Based on this analysis, some recommendations were made to improve the availability of information about CTs in Kazakhstan.
Ainur Sibagatova1, https://orcid.org/0000-0001-6399-3810
Gulnara Kulkayeva2, https://orcid.org/0000-0002-7883-211X
Balzhan Kassiyeva1, https://orcid.org/0000-0002-8452-7146
Andrey Avdeyev1, https://orcid.org/0000-0001-8509-6053
Olzhas Turar1, https://orcid.org/0000-0001-6378-0727
Rustam Albayev1, https://orcid.org/0000-0002-2689-2663
Nasrulla Shanazarov1, https://orcid.org/0000-0002-2976-259X
Talgat Nurgozhin2, https://orcid.org/0000-0002-8036-604X
Aissulu Issabekova2, https://orcid.org/0000-0002-8347-373X
1 Medical Center Hospital of the President’s Affairs Administration of the Republic of Kazakhstan,
Astana, Republic of Kazakhstan;
2 Salidat Kairbekova National Research Center for Health Development, Astana, Republic of Kazakhstan.
1. Об утверждении Положения по Центральной комиссии по биоэтике Приказ Министра здравоохранения Республики Казахстан. 2020. https://adilet.zan.kz/rus/docs/V2000021512 (Дата обращения: 10.07.2023)
2. Об утверждении правил проведения клинических исследований лекарственных средств и медицинских изделий для диагностики вне живого организма (in vitro) и требования к клиническим базам и оказания государственной услуги "Выдача разрешения на проведение клинического исследования и (или) испытания фармакологических и лекарственных средств, медицинских изделий" https://adilet.zan.kz/rus/docs/V2000021772 (Дата обращения: 10.07.2023)
3. Al-Durra M., Nolan R.P., Seto E., Cafazzo J.A. Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations // Bmj, 2020. 369, m982. https://doi.org/10.1136/bmj.m982 (Дата обращения: 10.07.2023)
4. Declaration of Helsinki – Ethical principles for medical research involving human subjects, 2013. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (Дата обращения: 10.07.2023)
5. Epi E.F. EF English Proficiency Index A Ranking of 112 Countries and Regions by English Skills. 2021. https://www.ef.com/assetscdn/WIBIwq6RdJvcD9bc8RMd/cefcom-epi-site/reports/2021/ef-epi-2021-english.pdf (Дата обращения: 10.07.2023)
6. Huiskens J., Kool B.R., Bakker J.M., Bruns E.R., de Jonge S.W., Olthof P.B., van Rosmalen B.V., van Gulik T.M., Hooft L., Punt C.J. From registration to publication: A study on Dutch academic randomized controlled trials // Res Synth Methods, 2020. 11(2), 218-226. https://doi.org/10.1002/jrsm.1379 (Дата обращения: 09.08.2023)
7. Jull A., Walker N. Trial registration and time to publication in a retrospective cohort of publicly funded randomised controlled trials in New Zealand 1999-2017 // BMJ Open, 2022. 12(10), e065050. https://doi.org/10.1136/bmjopen-2022-065050 (Дата обращения: 10.07.2023)
8. Koikov V., Abduazhitova A. et al. Creation of motivational mechanisms for the development of the clinical trials market in the Republic of Kazakhstan: Policy Brief // Journal of Health Development, 2019. 34 (Special Issue), 4-15. https://doi.org/https://doi.org/10.32921/2225-9929-9929-2019-34-4-15 (Дата обращения: 10.09.2023)
9. Lamberink H.J., Vinkers C.H., Lancee M., Damen J.A., Bouter L.M., Otte W.M., Tijdink J.K. Clinical Trial Registration Patterns and Changes in Primary Outcomes of Randomized Clinical Trials From 2002 to 2017 // JAMA Intern Med, 2022. 182(7), 779-782. https://doi.org/10.1001/jamainternmed.2022.1551 (Дата обращения: 10.10.2023)
10. Sándor-Bajusz K.A., Kraut A., Baasan O., Márovics G., Berényi K., Lohner S. Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary // Trials, 2022. 23(1), 330. https://doi.org/10.1186/s13063-022-06268-y (Дата обращения: 10.10.2023)
11. World Health Organization. Number of trials by country or area. Retrieved 10.09. From https://www.who.int/observatories/global-observatory-on-health-research-and-development/monitoring/number-of-clinical-trials-by-year-country-who-region-and-income-group (Ддата обращения: 4.07.2023)
12. World Health Organization. Trial registration. Retrieved 10.09 from https://www.who.int/clinical-trials-registry-platform/network/trial-registration (Дата обращения: 5.07.2023)
References: [1-2]
1. Ob utverzhdenii Polozheniya po Tsentral`noi komissii po bioetike Prikaz Ministra zdravookhraneniya Respubliki Kazakhstan [Order on approval of the Regulations on the Central Commission on Bioethics] (2020). https://adilet.zan.kz/rus/docs/V2000021512 (accessed: 10.07.2023) [in Russian]
2. Ob utverzhdenii pravil provedeniya klinicheskikh issledovanii lekarstvennykh sredstv i meditsinskikh izdelii dlya diagnostiki vne zhivogo organizma (in vitro) i trebovaniya k klinicheskim bazam i okazaniya gosudarstvennoi uslugi "Vydacha razresheniya na provedenie klinicheskogo issledovaniya i (ili) ispytaniya farmakologicheskikh i lekarstvennykh sredstv, meditsinskikh izdelii" [On approval of the rules for conducting clinical trials of medicines and medical devices for diagnostics outside a living organism (in vitro) and the requirements for clinical sites and the provision of the state service "Issue of permission to conduct a clinical trial and (or) test of pharmacological and medicinal products, medical devices"] https://adilet.zan.kz/rus/docs/V2000021772 (accessed: 10.07.2023) [in Russian]
Количество просмотров: 408
Категория статей:
Оригинальные исследования
Библиографическая ссылка
Sibagatova A., Kulkayeva G., Kassiyeva B., Avdeyev A., Turar O., Albayev R., Shanazarov N., Nurgozhin T., Issabekova A. Analysis of the current situation on the availability of information on ongoing clinical trials in the Republic of Kazakhstan // Nauka i Zdravookhranenie [Science & Healthcare]. 2023, (Vol.25) 6, pp. 7-14. doi 10.34689/SH.2023.25.6.001Похожие публикации:
TRENDS IN MORBIDITY AND MORTALITY FROM CHRONIC HEART FAILURE IN ALMATY
СТРУКТУРНО-ФУНКЦИОНАЛЬНЫЕ ИЗМЕНЕНИЯ МИОКАРДА ПОСЛЕ АОРТОКОРОНАРНОГО ШУНТИРОВАНИЯ У ПАЦИЕНТОВ С ИЗБЫТОЧНОЙ МАССОЙ ТЕЛА НА РАЗНЫХ ЭТАПАХ РЕАБИЛИТАЦИИ
МЕДИКО – СОЦИАЛЬНЫЕ, ПСИХОЛОГИЧЕСКИЕ АСПЕКТЫ КАЧЕСТВА ЖИЗНИ БОЛЬНЫХ С ОСТРЫМ ПАНКРЕАТИТОМ
A COMPARATIVE ANALYSIS OF 24-HOUR DIETARY RECALLS AND FOOD FREQUENCY QUESTIONNAIRES ADMINISTERED SIMULTANEOUSLY IN THE KAZAKHSTANI POPULATION
ANALYSIS OF PATIENT SATISFACTION WITH THE QUALITY OF ORGANIZATION OF TREATMENT IN FOREIGN CLINICS