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Evolution of clinical trials in multiple sclerosis
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| Zeitschriftentitel: | Therapeutic Advances in Neurological Disorders |
|---|---|
| Personen und Körperschaften: | , , , , |
| In: | Therapeutic Advances in Neurological Disorders, 12, 2019, S. 175628641982654 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
SAGE Publications
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| Schlagwörter: |
| author_facet |
Zhang, Yinan Salter, Amber Wallström, Erik Cutter, Gary Stüve, Olaf Zhang, Yinan Salter, Amber Wallström, Erik Cutter, Gary Stüve, Olaf |
|---|---|
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Zhang, Yinan Salter, Amber Wallström, Erik Cutter, Gary Stüve, Olaf |
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Zhang, Yinan Salter, Amber Wallström, Erik Cutter, Gary Stüve, Olaf Therapeutic Advances in Neurological Disorders Evolution of clinical trials in multiple sclerosis Neurology (clinical) Neurology Pharmacology |
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zhang, yinan |
| spelling |
Zhang, Yinan Salter, Amber Wallström, Erik Cutter, Gary Stüve, Olaf 1756-2864 1756-2864 SAGE Publications Neurology (clinical) Neurology Pharmacology http://dx.doi.org/10.1177/1756286419826547 <jats:p> Clinical trials have advanced the treatment of multiple sclerosis (MS) by demonstrating the safety and efficacy of disease-modifying therapies (DMTs). This review discusses major changes to MS clinical trials in the era of DMTs. As treatment options for MS continue to increase, patients in modern MS trials present earlier and with milder disease compared with historic MS populations. While placebo-controlled trials for some questions may still be relevant, DMT trials in relapsing–remitting MS (RRMS) are no longer ethical. The replacement of the placebo arm by an active comparator arm in trials have raised the cost of trials by requiring larger sample sizes to detect on-study changes in treatment effects. Efforts to improve trial efficiency in RRMS have focused on exploring adaptive designs and relying on sensitive magnetic resonance imaging measures of disease activity. In trials for progressive forms of MS (PMS), the lack of sensitive outcome measures that can be used in shorter-term trials have delayed the development of effective treatments. Recent shifting of the focus to advancing trials in PMS has identified paraclinical outcome measurements with improved potential, and the testing of agents for neuroprotection and remyelination is in progress. </jats:p> Evolution of clinical trials in multiple sclerosis Therapeutic Advances in Neurological Disorders |
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Evolution of clinical trials in multiple sclerosis |
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Evolution of clinical trials in multiple sclerosis |
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Evolution of clinical trials in multiple sclerosis |
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Evolution of clinical trials in multiple sclerosis |
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Evolution of clinical trials in multiple sclerosis |
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Evolution of clinical trials in multiple sclerosis |
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evolution of clinical trials in multiple sclerosis |
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Neurology (clinical) Neurology Pharmacology |
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http://dx.doi.org/10.1177/1756286419826547 |
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2019 |
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<jats:p> Clinical trials have advanced the treatment of multiple sclerosis (MS) by demonstrating the safety and efficacy of disease-modifying therapies (DMTs). This review discusses major changes to MS clinical trials in the era of DMTs. As treatment options for MS continue to increase, patients in modern MS trials present earlier and with milder disease compared with historic MS populations. While placebo-controlled trials for some questions may still be relevant, DMT trials in relapsing–remitting MS (RRMS) are no longer ethical. The replacement of the placebo arm by an active comparator arm in trials have raised the cost of trials by requiring larger sample sizes to detect on-study changes in treatment effects. Efforts to improve trial efficiency in RRMS have focused on exploring adaptive designs and relying on sensitive magnetic resonance imaging measures of disease activity. In trials for progressive forms of MS (PMS), the lack of sensitive outcome measures that can be used in shorter-term trials have delayed the development of effective treatments. Recent shifting of the focus to advancing trials in PMS has identified paraclinical outcome measurements with improved potential, and the testing of agents for neuroprotection and remyelination is in progress. </jats:p> |
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| description | <jats:p> Clinical trials have advanced the treatment of multiple sclerosis (MS) by demonstrating the safety and efficacy of disease-modifying therapies (DMTs). This review discusses major changes to MS clinical trials in the era of DMTs. As treatment options for MS continue to increase, patients in modern MS trials present earlier and with milder disease compared with historic MS populations. While placebo-controlled trials for some questions may still be relevant, DMT trials in relapsing–remitting MS (RRMS) are no longer ethical. The replacement of the placebo arm by an active comparator arm in trials have raised the cost of trials by requiring larger sample sizes to detect on-study changes in treatment effects. Efforts to improve trial efficiency in RRMS have focused on exploring adaptive designs and relying on sensitive magnetic resonance imaging measures of disease activity. In trials for progressive forms of MS (PMS), the lack of sensitive outcome measures that can be used in shorter-term trials have delayed the development of effective treatments. Recent shifting of the focus to advancing trials in PMS has identified paraclinical outcome measurements with improved potential, and the testing of agents for neuroprotection and remyelination is in progress. </jats:p> |
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| spelling | Zhang, Yinan Salter, Amber Wallström, Erik Cutter, Gary Stüve, Olaf 1756-2864 1756-2864 SAGE Publications Neurology (clinical) Neurology Pharmacology http://dx.doi.org/10.1177/1756286419826547 <jats:p> Clinical trials have advanced the treatment of multiple sclerosis (MS) by demonstrating the safety and efficacy of disease-modifying therapies (DMTs). This review discusses major changes to MS clinical trials in the era of DMTs. As treatment options for MS continue to increase, patients in modern MS trials present earlier and with milder disease compared with historic MS populations. While placebo-controlled trials for some questions may still be relevant, DMT trials in relapsing–remitting MS (RRMS) are no longer ethical. The replacement of the placebo arm by an active comparator arm in trials have raised the cost of trials by requiring larger sample sizes to detect on-study changes in treatment effects. Efforts to improve trial efficiency in RRMS have focused on exploring adaptive designs and relying on sensitive magnetic resonance imaging measures of disease activity. In trials for progressive forms of MS (PMS), the lack of sensitive outcome measures that can be used in shorter-term trials have delayed the development of effective treatments. Recent shifting of the focus to advancing trials in PMS has identified paraclinical outcome measurements with improved potential, and the testing of agents for neuroprotection and remyelination is in progress. </jats:p> Evolution of clinical trials in multiple sclerosis Therapeutic Advances in Neurological Disorders |
| spellingShingle | Zhang, Yinan, Salter, Amber, Wallström, Erik, Cutter, Gary, Stüve, Olaf, Therapeutic Advances in Neurological Disorders, Evolution of clinical trials in multiple sclerosis, Neurology (clinical), Neurology, Pharmacology |
| title | Evolution of clinical trials in multiple sclerosis |
| title_full | Evolution of clinical trials in multiple sclerosis |
| title_fullStr | Evolution of clinical trials in multiple sclerosis |
| title_full_unstemmed | Evolution of clinical trials in multiple sclerosis |
| title_short | Evolution of clinical trials in multiple sclerosis |
| title_sort | evolution of clinical trials in multiple sclerosis |
| title_unstemmed | Evolution of clinical trials in multiple sclerosis |
| topic | Neurology (clinical), Neurology, Pharmacology |
| url | http://dx.doi.org/10.1177/1756286419826547 |