TY - JOUR
T1 - Towards early inclusion of children in tuberculosis drugs trials
T2 - A consensus statement
AU - Nachman, Sharon
AU - Ahmed, Amina
AU - Amanullah, Farhana
AU - Becerra, Mercedes C.
AU - Botgros, Radu
AU - Brigden, Grania
AU - Browning, Renee
AU - Gardiner, Elizabeth
AU - Hafner, Richard
AU - Hesseling, Anneke
AU - How, Cleotilde
AU - Jean-Philippe, Patrick
AU - Lessem, Erica
AU - Makhene, Mamodikoe
AU - Mbelle, Nontombi
AU - Marais, Ben
AU - McIlleron, Helen
AU - McNeeley, David F.
AU - Mendel, Carl
AU - Murray, Stephen
AU - Navarro, Eileen
AU - Anyalechi, E. Gloria
AU - Porcalla, Ariel R.
AU - Powell, Clydette
AU - Powell, Mair
AU - Rigaud, Mona
AU - Rouzier, Vanessa
AU - Samson, Pearl
AU - Schaaf, H. Simon
AU - Shah, Seema
AU - Starke, Jeff
AU - Swaminathan, Soumya
AU - Wobudeya, Eric
AU - Worrell, Carol
N1 - Publisher Copyright:
© 2015 Elsevier Ltd.
PY - 2015/6/1
Y1 - 2015/6/1
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/84929511425
U2 - 10.1016/S1473-3099(15)00007-9
DO - 10.1016/S1473-3099(15)00007-9
M3 - Review article
C2 - 25957923
AN - SCOPUS:84929511425
SN - 1473-3099
VL - 15
SP - 711
EP - 720
JO - The Lancet Infectious Diseases
JF - The Lancet Infectious Diseases
IS - 6
ER -