Current ethical issues of clinical trials of drugs for the pathogenetic therapy of multiple sclerosis in the context of the COVID-19 pandemic
Abstract
The spread of the COVID-19 pandemic posed a serious challenge for scientific and clinical medical institutions in terms of research for new multiple sclerosis (MS) treatments. In this review we discuss the associations between coronavirus infection and MS and provide data on the features of MS pathogenetic therapy during a pandemic. We also analyze the ethical aspects of clinical trials, the problems faced by researchers and patients, especially when using immunosuppressive therapy for MS. We provide examples of violations during research caused by the influence of a pandemic, as well as ways of solving them. Improving ethical standards is an essential component of ensuring the safety of MS and other immune-mediated diseases treatment.
About the Authors
E. V. IvashkovaRussian Federation
Elena Vladimirovna Ivashkova
9, Acad. Pavlov St., Saint Petersburg 197376
A. M. Petrov
Russian Federation
9, Acad. Pavlov St., Saint Petersburg 197376
M. V. Votintseva
Russian Federation
9, Acad. Pavlov St., Saint Petersburg 197376
I. D. Stolyarov
Russian Federation
9, Acad. Pavlov St., Saint Petersburg 197376
References
1. Nezhmetdinova FT, Guryleva ME. Medical social and ethical issues related to COVID-19. Kazanskij medicinskij zhurnal = Kazan Medical Journal. 2020;101(6):841-51. doi: 10.17816/KMJ2020-841 (In Russ.).
2. Ivashkova IV, Votintseva MV, Petrov AM, Stolyarov ID. Ethical, clinical and scientific aspects of a research of medicinal drugs that alter progress of a multiple sclerosis at the current staging point. Vestnik Roszdravnadzora. 2019;(3):63-9. doi: 10.35576/article_5d135f4a66dc90.50757456 (In Russ.).
3. Gusev EI, Boiko AN, Stolyarov ID. Rasseyannyi skleroz [Multiple sclerosis]. Moscow: Zdorov'e cheloveka; 2015. 448 p. (In Russ.).
4. ClinicalTrials. Available from: https//ClinicalTrials.gov
5. Khokhlova AL, Polozova EA, Komissarova VA, et al. Risks associated with the ethical aspects of conducting clinical trials. Kachestvennaya klinicheskaya praktika. 2020;(1):61-8 (In Russ.).
6. Letter of the Ministry of Health of the Russian Federation No. 20-1/I/2-3651 of 27.03.2020 «On the issues of conducting clinical trials of drugs in the context of the COVID-19 coronavirus pandemic» (In Russ.).
7. Emanuel E, Emanuel L. Four models of the Physician-patient Relationship. JAMA. 1992 Apr 22-29;267(16):2221-6.
8. Vitch R. Models of moral medicine in the era of revolutionary changes. Voprosy filosofii. 1994;(3):67-72 (In Russ.).
9. Boyko AN, Lasch NU, Spirin N, et al. Management of patients with multiple sclerosis in the context of the COVIND-1 pandemic. Temporary guidelines. Version 1 of 19.04.2020 Available from: https://www.ructrims.org/files/2020/РС_и_COVID-19_Рекомендации_ВОН.pdf (In Russ.).
10. ABN Guidance on DMTs for MS and COVID-19 (British Association of Neurologists). Available from: https://cdn.ymaws.com/www.theabn.org/resource/collection/6750BAE6-4CBC-4DDBA684-116E03BFE634/ABN_Guidance_on_DMTs_for_MS_and_COVID19.pdf
11. ABN guidance on the use of disease-modifying therapies in multiple sclerosis in response to the threat of a coronavirus epidemic. Available from: https://cdn.ymaws.com/www.theabn.org/resource/collection/6750BAE6-4CBC-4DDB-A684-116E03BFE634/ABN_Guidance_on_DMTs_for_MS_and_COVID19_APPROVED_11_March.pdf
12. Coronavirus SARS-CoV-2: Hinweise zur Anwendung von MS-Immuntherapeutika. Stellungnahme des Kompetenznetz Multiple Sklerosee. Available from: https://www.ructrims.org/files/2020/KKNMS_Stellungnahme_MS-Immuntherapeutika_Covid-19_web_frei.pdf
13. Petrov AM, Ivashkova EV, Stolyarov ID. New opportunities for the treatment of secondary progressive multiple sclerosis. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2019;11(4):125-9. doi: 10.14412/2074-2711-2019-4-125-129 (In Russ.).
14. Clinical Trial Conduct During the COVID-19 Pandemic. March 2020, updated June 2020. Available from: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/clinical-trial-conduct-during-covid-19-pandemic
Review
For citations:
Ivashkova E.V., Petrov A.M., Votintseva M.V., Stolyarov I.D. Current ethical issues of clinical trials of drugs for the pathogenetic therapy of multiple sclerosis in the context of the COVID-19 pandemic. Neurology, Neuropsychiatry, Psychosomatics. 2021;13(1S):69-72. (In Russ.) https://doi.org/10.14412/2074-2711-2021-1S-69-72