Current requirements for studies of drugs for the pathogenetic treatment of multiple sclerosis
More than 10 multiple sclerosis-modifying drugs (MSMDs) are widely used now. Novel MSMDs should be investigated in strict accordance with the evidence-based medicine principles governing clinical trials (of both original drugs and their analogues) that prove the high efficiency, safety, and tolerabi...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | Russian |
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IMA-PRESS LLC
2019-12-01
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| Series: | Неврология, нейропсихиатрия, психосоматика |
| Subjects: | |
| Online Access: | https://nnp.ima-press.net/nnp/article/view/1229 |
| _version_ | 1797876353210515456 |
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| author | A. N. Boyko N. N. Spirin Ya. V. Vlasov M. N. Zakharova |
| author_facet | A. N. Boyko N. N. Spirin Ya. V. Vlasov M. N. Zakharova |
| author_sort | A. N. Boyko |
| collection | DOAJ |
| description | More than 10 multiple sclerosis-modifying drugs (MSMDs) are widely used now. Novel MSMDs should be investigated in strict accordance with the evidence-based medicine principles governing clinical trials (of both original drugs and their analogues) that prove the high efficiency, safety, and tolerability of new drugs versus the already existing ones. Russia has gained extensive experience in conducting such studies using the well-known drugs as a comparison group. The efficiency and safety of new therapy should be evaluated according to the international criteria on the basis of a sufficient number of patients during a long-term follow-up. When combining the drugs, their efficiency and the risk of adverse effects can vary. The published results of a small study of the combined drug Leucovir (Belarus) do not meet these requirements, and the possibility of using this drug to treat multiple sclerosis can be discussed only after adequate phases II and III clinical trials. |
| first_indexed | 2024-04-10T02:01:52Z |
| format | Article |
| id | doaj.art-543d13c7f39f40a5a77ad3ffddc25e81 |
| institution | Directory Open Access Journal |
| issn | 2074-2711 2310-1342 |
| language | Russian |
| last_indexed | 2024-04-10T02:01:52Z |
| publishDate | 2019-12-01 |
| publisher | IMA-PRESS LLC |
| record_format | Article |
| series | Неврология, нейропсихиатрия, психосоматика |
| spelling | doaj.art-543d13c7f39f40a5a77ad3ffddc25e812023-03-13T08:42:19ZrusIMA-PRESS LLCНеврология, нейропсихиатрия, психосоматика2074-27112310-13422019-12-0111416617110.14412/2074-2711-2019-4-166-171941Current requirements for studies of drugs for the pathogenetic treatment of multiple sclerosisA. N. Boyko0N. N. Spirin1Ya. V. Vlasov2M. N. Zakharova3Department of Neurology, Neurosurgery, and Medical Genetics, N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia; Department of Neuroimmunology, Federal Center for Cerebrovascular Pathology and Stroke, Ministry of Health of RussiaDepartment of Neurology, Neurosurgery, and Medical Genetics, Yaroslavl State Medical University, Ministry of Health of RussiaDepartment of Neurology and Neurosurgery, Samara State Medical University, Ministry of Health of RussiaResearch Center of Neurology, Ministry of Education and Science of RussiaMore than 10 multiple sclerosis-modifying drugs (MSMDs) are widely used now. Novel MSMDs should be investigated in strict accordance with the evidence-based medicine principles governing clinical trials (of both original drugs and their analogues) that prove the high efficiency, safety, and tolerability of new drugs versus the already existing ones. Russia has gained extensive experience in conducting such studies using the well-known drugs as a comparison group. The efficiency and safety of new therapy should be evaluated according to the international criteria on the basis of a sufficient number of patients during a long-term follow-up. When combining the drugs, their efficiency and the risk of adverse effects can vary. The published results of a small study of the combined drug Leucovir (Belarus) do not meet these requirements, and the possibility of using this drug to treat multiple sclerosis can be discussed only after adequate phases II and III clinical trials.https://nnp.ima-press.net/nnp/article/view/1229multiple sclerosistreatmentmultiple sclerosis-modifying drugsclinical trials |
| spellingShingle | A. N. Boyko N. N. Spirin Ya. V. Vlasov M. N. Zakharova Current requirements for studies of drugs for the pathogenetic treatment of multiple sclerosis Неврология, нейропсихиатрия, психосоматика multiple sclerosis treatment multiple sclerosis-modifying drugs clinical trials |
| title | Current requirements for studies of drugs for the pathogenetic treatment of multiple sclerosis |
| title_full | Current requirements for studies of drugs for the pathogenetic treatment of multiple sclerosis |
| title_fullStr | Current requirements for studies of drugs for the pathogenetic treatment of multiple sclerosis |
| title_full_unstemmed | Current requirements for studies of drugs for the pathogenetic treatment of multiple sclerosis |
| title_short | Current requirements for studies of drugs for the pathogenetic treatment of multiple sclerosis |
| title_sort | current requirements for studies of drugs for the pathogenetic treatment of multiple sclerosis |
| topic | multiple sclerosis treatment multiple sclerosis-modifying drugs clinical trials |
| url | https://nnp.ima-press.net/nnp/article/view/1229 |
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