Um estudo para comparar a eficácia, segurança e tolerabilidade de FF/UMEC/VI com FF/VI em crianças de 12 a 17 anos com asma
Um estudo de empréstimo dinâmico bayesiano de grupo paralelo, randomizado, de 24 semanas, de 24 semanas, comparando a eficácia, segurança, tolerabilidade e farmacocinética de FF/UMEC/VI com FF/VI em participantes de 12 a 17 anos de idade com Asma inadequadamente controlada em terapia de manutenção estável com ICS/LABA
The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Buenos Aires, Argentina, C1425BEN
- GSK Investigational Site
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Buenos Aires, Argentina, C1202
- GSK Investigational Site
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Buenos Aires, Argentina, 1888
- GSK Investigational Site
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Buenos Aires, Argentina, 1122
- GSK Investigational Site
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Buenos Aires, Argentina, C1023AAB
- GSK Investigational Site
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Córdoba, Argentina, X5000DCE
- GSK Investigational Site
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Córdoba, Argentina, X5014AKM
- GSK Investigational Site
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Lanus, Argentina, B1824KAJ
- GSK Investigational Site
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Lobos, Argentina, 7240
- GSK Investigational Site
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Lujan de Cuyo, Argentina, 5509
- GSK Investigational Site
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Mar del Plata, Argentina, 7600
- GSK Investigational Site
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Rosario, Argentina, 2000
- GSK Investigational Site
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Rosario Provincia de Santa FE, Argentina, 2000
- GSK Investigational Site
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San Miguel de Tucumán, Argentina, T4000IHE
- GSK Investigational Site
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Santa Fe, Argentina, 3000
- GSK Investigational Site
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Queensland
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South Brisbane, Queensland, Austrália, 4101
- GSK Investigational Site
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South Australia
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North Adelaide, South Australia, Austrália, 5006
- GSK Investigational Site
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Western Australia
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Joondalup WA, Western Australia, Austrália, 6027
- GSK Investigational Site
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Lo Barnechea, Chile, 7691236
- GSK Investigational Site
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Santiago, Chile, 7630000
- GSK Investigational Site
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Santiago, Chile, 8320000
- GSK Investigational Site
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Cheongju Chungcheongbuk-do, Coréia do Sul, 28644
- GSK Investigational Site
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Gwangju, Coréia do Sul, 501-757
- GSK Investigational Site
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Seoul, Coréia do Sul, 05505
- GSK Investigational Site
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Seoul, Coréia do Sul, 03722
- GSK Investigational Site
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Seoul, Coréia do Sul, 1757
- GSK Investigational Site
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Seoul, Coréia do Sul, 2447
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, Estados Unidos, 35244
- GSK Investigational Site
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Mobile, Alabama, Estados Unidos, 36608
- GSK Investigational Site
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Arizona
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Paradise Valley, Arizona, Estados Unidos, 85253
- GSK Investigational Site
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California
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Bakersfield, California, Estados Unidos, 93301-4205
- GSK Investigational Site
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Huntington Beach, California, Estados Unidos, 92647
- GSK Investigational Site
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Mission Viejo, California, Estados Unidos, 92691
- GSK Investigational Site
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Rolling Hills Estates, California, Estados Unidos, 90274
- GSK Investigational Site
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80909
- GSK Investigational Site
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Florida
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Aventura, Florida, Estados Unidos, 33180
- GSK Investigational Site
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Miami, Florida, Estados Unidos, 33173
- GSK Investigational Site
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Miami, Florida, Estados Unidos, 33165
- GSK Investigational Site
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Miami, Florida, Estados Unidos, 33174
- GSK Investigational Site
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Georgia
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Savannah, Georgia, Estados Unidos, 31406
- GSK Investigational Site
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Illinois
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Normal, Illinois, Estados Unidos, 61761
- GSK Investigational Site
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Kentucky
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Owensboro, Kentucky, Estados Unidos, 42301
- GSK Investigational Site
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Missouri
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Columbia, Missouri, Estados Unidos, 65203
- GSK Investigational Site
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Montana
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Missoula, Montana, Estados Unidos, 59808
- GSK Investigational Site
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New York
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The Bronx, New York, Estados Unidos, 10461-1119
- GSK Investigational Site
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- GSK Investigational Site
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Cleveland, Ohio, Estados Unidos, 44106
- GSK Investigational Site
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Dayton, Ohio, Estados Unidos, 45404
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73120-9350
- GSK Investigational Site
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29420
- GSK Investigational Site
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Texas
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Dallas, Texas, Estados Unidos, 75225-6301
- GSK Investigational Site
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Kerrville, Texas, Estados Unidos, 78028
- GSK Investigational Site
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Plano, Texas, Estados Unidos, 75034
- GSK Investigational Site
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Waco, Texas, Estados Unidos, 76712
- GSK Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- GSK Investigational Site
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Ashkelon, Israel, 7830604
- GSK Investigational Site
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Haifa, Israel, 3436212
- GSK Investigational Site
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Haifa, Israel, 3109600
- GSK Investigational Site
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Petah Tikva, Israel, 49202
- GSK Investigational Site
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Guadalajara, México, 44100
- GSK Investigational Site
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Monterrey, México, 64460
- GSK Investigational Site
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San Juan del Río, México, 76800
- GSK Investigational Site
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Upper Hutt
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Ebdentown, Upper Hutt, Nova Zelândia, 5018
- GSK Investigational Site
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Adana, Turquia (Türkiye), 1173
- GSK Investigational Site
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Antalya, Turquia (Türkiye), 07070
- GSK Investigational Site
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Istanbul, Turquia (Türkiye), 34010
- GSK Investigational Site
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Istanbul, Turquia (Türkiye), 34899
- GSK Investigational Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent.
- Participants who have a diagnosis of asthma as defined by the National Institutes of Health [NIH, 2020] at least 1 year prior to Visit 0.
- Participants who have required daily Inhaled corticosteroids (ICS)/ Long-Acting Beta2-Agonist (LABA) treatment for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total ICS dose of >250 to <=500 microgram (mcg)/day fluticasone propionate, or equivalent).
- In the 1 year prior to Visit 1: A documented healthcare contact for acute asthma symptoms; OR A documented temporary change in asthma therapy for acute asthma symptoms, according to a prespecified asthma action plan (or equivalent).
- Participants with inadequately controlled asthma (ACQ-6 score ≥1.5) at Visit 1, despite ICS/LABA maintenance therapy.
- A best pre-bronchodilator FEV1 >40% to <=90% of the predicted normal value and a ≥12% increase in FEV1 with albuterol/salbutamol at Visit 1. Predicted values will be based on the European Respiratory Society (ERS) Global Lung Function Initiative.
Exclusion Criteria:
- Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
- Any asthma exacerbation requiring a change in maintenance asthma therapy and/or the use of systemic corticosteroids for at least 3 days in the 6 weeks prior to Visit 1. (Participants requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the participant's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification), returned to their baseline asthma status and they are considered appropriate for enrollment into this study of up to 6 months duration)
- History of Life-threatening Asthma
- Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.).
- Current smokers and users of other inhaled products for recreation with or without nicotine (defined as participants who use cigarettes, e-cigarettes, other/vaping-related devices, cigars or pipe tobacco]) within 12 months prior to Visit 1.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Participantes recebendo FF/UMEC/VI
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FF/UMEC/VI will be administered. FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler |
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Comparador Ativo: Participantes recebendo FF/VI
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FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler FF/VI will be administered. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
Prazo: Baseline (Week 0) and Week 24
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FEV1 will be measured using spirometry. |
Baseline (Week 0) and Week 24
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)
Prazo: Baseline (Week 0) and Week 24
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ACQ-7 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)), a question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. |
Baseline (Week 0) and Week 24
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Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale)
Prazo: Baseline (Week 0) and Week 24
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ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. |
Baseline (Week 0) and Week 24
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Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale)
Prazo: Baseline (Week 0) and Week 24
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ACQ-5 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. |
Baseline (Week 0) and Week 24
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Number of Participants with a clinically important change from baseline in ACQ-7 Score
Prazo: Week 24
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ACQ-7 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)), a question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score. |
Week 24
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Number of Participants with a clinically important change from baseline in ACQ-6 Score
Prazo: Week 24
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ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score. |
Week 24
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Number of Participants with a clinically important change from baseline in ACQ-5 Score
Prazo: Week 24
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ACQ-5 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score. |
Week 24
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: GSK Clinical Trials, GlaxoSmithKline
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 206867
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Prazo de Compartilhamento de IPD
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Critérios de acesso de compartilhamento IPD
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
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