Towards early inclusion of children in tuberculosis drugs trials: a consensus statement
Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxi...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Nachman, Sharon [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2015transfer abstract |
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| Umfang: |
10 |
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| Übergeordnetes Werk: |
Enthalten in: Identification of Advanced Fibrosis in Hepatitis C Patients following Sustained Virologic Response: A New Predictive Model - Berhane, S. ELSEVIER, 2016, New York, NY |
|---|---|
| Übergeordnetes Werk: |
volume:15 ; year:2015 ; number:6 ; pages:711-720 ; extent:10 |
| Links: |
|---|
| DOI / URN: |
10.1016/S1473-3099(15)00007-9 |
|---|
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ELV028712994 |
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| 520 | |a Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. | ||
| 520 | |a Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. | ||
| 700 | 1 | |a Ahmed, Amina |4 oth | |
| 700 | 1 | |a Amanullah, Farhana |4 oth | |
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| 700 | 1 | |a Browning, Renee |4 oth | |
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| 700 | 1 | |a Hesseling, Anneke |4 oth | |
| 700 | 1 | |a How, Cleotilde |4 oth | |
| 700 | 1 | |a Jean-Philippe, Patrick |4 oth | |
| 700 | 1 | |a Lessem, Erica |4 oth | |
| 700 | 1 | |a Makhene, Mamodikoe |4 oth | |
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| 700 | 1 | |a Marais, Ben |4 oth | |
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10.1016/S1473-3099(15)00007-9 doi GBVA2015004000030.pica (DE-627)ELV028712994 (ELSEVIER)S1473-3099(15)00007-9 DE-627 ger DE-627 rakwb eng 610 610 DE-600 610 VZ 610 VZ 44.44 bkl Nachman, Sharon verfasserin aut Towards early inclusion of children in tuberculosis drugs trials: a consensus statement 2015transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. Ahmed, Amina oth Amanullah, Farhana oth Becerra, Mercedes C oth Botgros, Radu oth Brigden, Grania oth Browning, Renee oth Gardiner, Elizabeth oth Hafner, Richard oth Hesseling, Anneke oth How, Cleotilde oth Jean-Philippe, Patrick oth Lessem, Erica oth Makhene, Mamodikoe oth Mbelle, Nontombi oth Marais, Ben oth McIlleron, Helen oth McNeeley, David F oth Mendel, Carl oth Murray, Stephen oth Navarro, Eileen oth Anyalechi, E Gloria oth Porcalla, Ariel R oth Powell, Clydette oth Powell, Mair oth Rigaud, Mona oth Rouzier, Vanessa oth Samson, Pearl oth Schaaf, H Simon oth Shah, Seema oth Starke, Jeff oth Swaminathan, Soumya oth Wobudeya, Eric oth Worrell, Carol oth Enthalten in Elsevier Berhane, S. ELSEVIER Identification of Advanced Fibrosis in Hepatitis C Patients following Sustained Virologic Response: A New Predictive Model 2016 New York, NY (DE-627)ELV013808834 volume:15 year:2015 number:6 pages:711-720 extent:10 https://doi.org/10.1016/S1473-3099(15)00007-9 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_11 GBV_ILN_26 GBV_ILN_40 GBV_ILN_70 44.44 Parasitologie Medizin VZ AR 15 2015 6 711-720 10 045F 610 |
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10.1016/S1473-3099(15)00007-9 doi GBVA2015004000030.pica (DE-627)ELV028712994 (ELSEVIER)S1473-3099(15)00007-9 DE-627 ger DE-627 rakwb eng 610 610 DE-600 610 VZ 610 VZ 44.44 bkl Nachman, Sharon verfasserin aut Towards early inclusion of children in tuberculosis drugs trials: a consensus statement 2015transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. Ahmed, Amina oth Amanullah, Farhana oth Becerra, Mercedes C oth Botgros, Radu oth Brigden, Grania oth Browning, Renee oth Gardiner, Elizabeth oth Hafner, Richard oth Hesseling, Anneke oth How, Cleotilde oth Jean-Philippe, Patrick oth Lessem, Erica oth Makhene, Mamodikoe oth Mbelle, Nontombi oth Marais, Ben oth McIlleron, Helen oth McNeeley, David F oth Mendel, Carl oth Murray, Stephen oth Navarro, Eileen oth Anyalechi, E Gloria oth Porcalla, Ariel R oth Powell, Clydette oth Powell, Mair oth Rigaud, Mona oth Rouzier, Vanessa oth Samson, Pearl oth Schaaf, H Simon oth Shah, Seema oth Starke, Jeff oth Swaminathan, Soumya oth Wobudeya, Eric oth Worrell, Carol oth Enthalten in Elsevier Berhane, S. ELSEVIER Identification of Advanced Fibrosis in Hepatitis C Patients following Sustained Virologic Response: A New Predictive Model 2016 New York, NY (DE-627)ELV013808834 volume:15 year:2015 number:6 pages:711-720 extent:10 https://doi.org/10.1016/S1473-3099(15)00007-9 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_11 GBV_ILN_26 GBV_ILN_40 GBV_ILN_70 44.44 Parasitologie Medizin VZ AR 15 2015 6 711-720 10 045F 610 |
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10.1016/S1473-3099(15)00007-9 doi GBVA2015004000030.pica (DE-627)ELV028712994 (ELSEVIER)S1473-3099(15)00007-9 DE-627 ger DE-627 rakwb eng 610 610 DE-600 610 VZ 610 VZ 44.44 bkl Nachman, Sharon verfasserin aut Towards early inclusion of children in tuberculosis drugs trials: a consensus statement 2015transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. Ahmed, Amina oth Amanullah, Farhana oth Becerra, Mercedes C oth Botgros, Radu oth Brigden, Grania oth Browning, Renee oth Gardiner, Elizabeth oth Hafner, Richard oth Hesseling, Anneke oth How, Cleotilde oth Jean-Philippe, Patrick oth Lessem, Erica oth Makhene, Mamodikoe oth Mbelle, Nontombi oth Marais, Ben oth McIlleron, Helen oth McNeeley, David F oth Mendel, Carl oth Murray, Stephen oth Navarro, Eileen oth Anyalechi, E Gloria oth Porcalla, Ariel R oth Powell, Clydette oth Powell, Mair oth Rigaud, Mona oth Rouzier, Vanessa oth Samson, Pearl oth Schaaf, H Simon oth Shah, Seema oth Starke, Jeff oth Swaminathan, Soumya oth Wobudeya, Eric oth Worrell, Carol oth Enthalten in Elsevier Berhane, S. ELSEVIER Identification of Advanced Fibrosis in Hepatitis C Patients following Sustained Virologic Response: A New Predictive Model 2016 New York, NY (DE-627)ELV013808834 volume:15 year:2015 number:6 pages:711-720 extent:10 https://doi.org/10.1016/S1473-3099(15)00007-9 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_11 GBV_ILN_26 GBV_ILN_40 GBV_ILN_70 44.44 Parasitologie Medizin VZ AR 15 2015 6 711-720 10 045F 610 |
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10.1016/S1473-3099(15)00007-9 doi GBVA2015004000030.pica (DE-627)ELV028712994 (ELSEVIER)S1473-3099(15)00007-9 DE-627 ger DE-627 rakwb eng 610 610 DE-600 610 VZ 610 VZ 44.44 bkl Nachman, Sharon verfasserin aut Towards early inclusion of children in tuberculosis drugs trials: a consensus statement 2015transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. Ahmed, Amina oth Amanullah, Farhana oth Becerra, Mercedes C oth Botgros, Radu oth Brigden, Grania oth Browning, Renee oth Gardiner, Elizabeth oth Hafner, Richard oth Hesseling, Anneke oth How, Cleotilde oth Jean-Philippe, Patrick oth Lessem, Erica oth Makhene, Mamodikoe oth Mbelle, Nontombi oth Marais, Ben oth McIlleron, Helen oth McNeeley, David F oth Mendel, Carl oth Murray, Stephen oth Navarro, Eileen oth Anyalechi, E Gloria oth Porcalla, Ariel R oth Powell, Clydette oth Powell, Mair oth Rigaud, Mona oth Rouzier, Vanessa oth Samson, Pearl oth Schaaf, H Simon oth Shah, Seema oth Starke, Jeff oth Swaminathan, Soumya oth Wobudeya, Eric oth Worrell, Carol oth Enthalten in Elsevier Berhane, S. ELSEVIER Identification of Advanced Fibrosis in Hepatitis C Patients following Sustained Virologic Response: A New Predictive Model 2016 New York, NY (DE-627)ELV013808834 volume:15 year:2015 number:6 pages:711-720 extent:10 https://doi.org/10.1016/S1473-3099(15)00007-9 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_11 GBV_ILN_26 GBV_ILN_40 GBV_ILN_70 44.44 Parasitologie Medizin VZ AR 15 2015 6 711-720 10 045F 610 |
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10.1016/S1473-3099(15)00007-9 doi GBVA2015004000030.pica (DE-627)ELV028712994 (ELSEVIER)S1473-3099(15)00007-9 DE-627 ger DE-627 rakwb eng 610 610 DE-600 610 VZ 610 VZ 44.44 bkl Nachman, Sharon verfasserin aut Towards early inclusion of children in tuberculosis drugs trials: a consensus statement 2015transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. Ahmed, Amina oth Amanullah, Farhana oth Becerra, Mercedes C oth Botgros, Radu oth Brigden, Grania oth Browning, Renee oth Gardiner, Elizabeth oth Hafner, Richard oth Hesseling, Anneke oth How, Cleotilde oth Jean-Philippe, Patrick oth Lessem, Erica oth Makhene, Mamodikoe oth Mbelle, Nontombi oth Marais, Ben oth McIlleron, Helen oth McNeeley, David F oth Mendel, Carl oth Murray, Stephen oth Navarro, Eileen oth Anyalechi, E Gloria oth Porcalla, Ariel R oth Powell, Clydette oth Powell, Mair oth Rigaud, Mona oth Rouzier, Vanessa oth Samson, Pearl oth Schaaf, H Simon oth Shah, Seema oth Starke, Jeff oth Swaminathan, Soumya oth Wobudeya, Eric oth Worrell, Carol oth Enthalten in Elsevier Berhane, S. ELSEVIER Identification of Advanced Fibrosis in Hepatitis C Patients following Sustained Virologic Response: A New Predictive Model 2016 New York, NY (DE-627)ELV013808834 volume:15 year:2015 number:6 pages:711-720 extent:10 https://doi.org/10.1016/S1473-3099(15)00007-9 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_11 GBV_ILN_26 GBV_ILN_40 GBV_ILN_70 44.44 Parasitologie Medizin VZ AR 15 2015 6 711-720 10 045F 610 |
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towards early inclusion of children in tuberculosis drugs trials: a consensus statement |
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Towards early inclusion of children in tuberculosis drugs trials: a consensus statement |
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Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. |
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Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. |
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Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. |
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What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained.</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? 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