Um Estudo para Investigar o Desfecho Clínico e a Qualidade de Vida em Doentes Chineses com CRSwNP Pós-operatório (PREDICT)
PREDICT: A Prospective, Multicenter Real-World Study to Describe the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP Patients
This is a prospective, multicenter real-world observational study designed to describe post-operative outcomes, quality of life, disease control, recurrence-related characteristics, economic burden and post-operative treatment patterns in Chinese patients with CRSwNP undergoing endoscopic sinus surgery (ESS).
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
This is a prospective, multicenter real-world observational study designed to describe post-operative outcomes, quality of life, disease control, recurrence-related characteristics, economic burden and post-operative treatment patterns in Chinese patients with CRSwNP undergoing endoscopic sinus surgery (ESS). Patients will receive standard medical care as determined by the treating physician at each site and, where possible, undergo scheduled study assessments that coincide with routine follow-up.
Approximately 200 patients diagnosed with CRSwNP by physicians and scheduled for surgical treatment will be enrolled from ~20 sites across different regions of China.
Potential participants will be identified during a screening period of up to 4 weeks before surgery. Participants who meet the eligibility criteria, provide informed consent, and undergo ESS during the screening period will be enrolled.
After enrolment, participants will undergo 52 weeks of post-operative follow-up. Planned follow-up timepoints are week 4 (Visit 2), week 12 (Visit 3), week 24 (Visit 4), week 36 (Visit 5), and week 52 (Visit 6). Follow-up data will be obtained from medical records, routine clinical assessments, and participant-reported questionnaires.
Tipo de estudo
Tipo de estudo
Inscrição (Real)
Inscrição
Contactos e Locais
Locais de estudo
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-
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Changchun, China, 130033
- Research Site
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Changsha, China
- Research Site
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Chengdu, China, 610078
- Research Site
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Guangzhou, China
- Research Site
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Guangzhou, China, 510062
- Research Site
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Guangzhou, China, 514700
- Research Site
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Haikou, China, 570311
- Research Site
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Kunming, China
- Research Site
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Nanchang, China
- Research Site
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Nanjing, China
- Research Site
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Nanning, China, 530021
- Research Site
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Qingdao, China
- Research Site
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Shanghai, China, 200031
- Research Site
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Shenzhen, China
- Research Site
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Wuhan, China
- Research Site
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Wuhan, China, 430000
- Research Site
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Xiamen, China, 361003
- Research Site
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Ürümqi, China, 830054
- Research Site
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Guangdong
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Guangzhou, Guangdong, China, 518106
- The Seventh Affiliated Hospital Sun Yat-sen University
-
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Liaoning
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Shenyang, Liaoning, China, 110002
- Shengjing Hospital of China Medical University
-
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Shandong
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Jinan, Shandong, China, 250012
- QiLu Hospital of Shandong University
-
-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Chinese CRSwNP Patients
Descrição
Inclusion Criteria:
- Participant must be 16 years of age or older, at the time of signing the informed consent.
- Participants with a documented diagnosis of bilateral CRSwNP.
- ESS is performed during the screening period.
- Voluntarily participate and sign the ICF.
- No history or current psychiatric disorders, with normal cognitive functions including understanding, expression, and orientation.
Exclusion Criteria:
- Any significant disease or disorder that the investigator believes may place the patient at risk or may affect the study results or the patient's ability to participate in the study.
- Use of biologic therapy for CRSwNP within 3 months prior to surgery.
- Currently participating in an interventional study.
- Patients who are unable to independently complete questionnaires due to language barriers or mental status.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: OTHER
- Perspectivas de Tempo: PROSPECTIVE
Número de grupos/coortes
Coortes e Intervenções
Grupo / CoorteGrupo / Coorte |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
CRSwNP Registry Cohort
This is a prospective, multicenter real-world observational study .Patients will receive standard medical care as determined by the treating physician according to routine clinical practice at each site. No treatment assignment will be made as part of the study. |
Patients will receive standard medical care as determined by the treating physician according to routine clinical practice at each site. No treatment assignment will be made as part of the study. |
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The observed value and change from baseline in SNOT-22 total score at week-52
Prazo: baseline-week52
|
To describe the Sino-Nasal Outcome Test (SNOT)-22 total score at 52 weeks post- operatively. [SNOT-22: score 0-5 each item, 5 means worse outcome, 22 items totally] |
baseline-week52
|
|
The observed value and change from baseline in MLK score at week-52
Prazo: baseline-week52
|
To describe the Modified Lund-Kennedy (MLK) score at 52 weeks post-operatively. [MLK score: score 0-24, 24 means worse outcome] |
baseline-week52
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The observed values and changes from baseline at each collection point: VAS - Total sinus symptoms item
Prazo: baseline-week52
|
To describe the changes in post-operative symptom by Visual Analogue Scale(VAS) total sinus symptoms . [VAS: score 0-10, 10 indicates worse outcome] |
baseline-week52
|
|
The observed values and changes from baseline in NPS at each collection point
Prazo: baseline-week52
|
To describe the changes in post-operative by Nasal Polyp Score (NPS). [NPS: score 0-4, 4 indicates worse outcome] |
baseline-week52
|
|
The observed values and changes from baseline at each collection point: VAS - Nasal blockage item
Prazo: baseline-week52
|
To describe the changes in post-operative symptom by Visual Analogue Scale(VAS) Nasal blockage item . [VAS: score 0-10, 10 indicates worse outcome] |
baseline-week52
|
|
The observed values and changes from baseline at each collection point: SNOT-22 Smell/taste Item Score
Prazo: baseline-week52
|
To describe the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Smell/taste Item Score. [SNOT-22: score 0-5 for each item, 5 means worse outcome] |
baseline-week52
|
|
The observed values and changes from baseline at each collection point: SNOT-22 Nasal Congestion Item Score
Prazo: baseline-week52
|
To describe the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Nasal Congestion Item Score. [SNOT-22: score 0-5 for each item, 5 means worse outcome] |
baseline-week52
|
|
The observed values and changes from baseline at each collection point: Nasal Congestion Score (NCS)
Prazo: baseline-week52
|
To describe the changes in post-operative symptom by Nasal Congestion Score(NCS). [NCS: score 0-3, 3 indicates worse outcome] |
baseline-week52
|
|
The observed values and changes from baseline at each collection point: Loss of Smell
Prazo: baseline-week52
|
To describe the changes in post-operative symptom by Loss of Smell Item Score. [ Loss of Smell : score 0-3 for each item, 3 means worse outcome] |
baseline-week52
|
|
The observed values and changes from baseline at each collection point: Nasal Airway Resistance (NAR)
Prazo: baseline-week52
|
To describe the changes in post-operative symptom by Nasal Airway Resistance(NAR). |
baseline-week52
|
|
Pre-operative, 24-week post-operatively, and 52- week post-operative Lund-Mackay CT Scores.
Prazo: week0-52
|
To describe the changes in post-operative CT Scores |
week0-52
|
|
The observed values and cChanges from baseline at each collection point: SF-36((Short Form Health Survey)
Prazo: baseline-week52
|
To describe the changes in post-operative Quality of Life by SF-36((Short Form Health Survey), which is a widely used questionnaire to measure health-related quality of life. |
baseline-week52
|
|
The observed values and changes from baseline at each collection point: The SNOT-22 top five items' frequency counts and average score
Prazo: baseline-week52
|
To describe the changes in post-operative Quality of Life by Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score. [SNOT-22: score 0-5 for each item, 5 means worse outcome] |
baseline-week52
|
|
The observed values and changes from baseline at each collection point: SNOT-22 sleep domain
Prazo: baseline-week52
|
To describe the changes in post-operative Sleep Quality [SNOT-22: score 0-5 for each item, 5 means worse outcome] |
baseline-week52
|
|
Intranasal corticosteroids (INCS): the proportion of participants using INCS.
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by the proportion of participants using Intranasal corticosteroids (INCS). |
week0-52
|
|
The daily dosage of participants used Systemic glucocorticoids (SCSs) for CRSwNP
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • The daily dosage (convert according to the equivalent dose of prednisone.) of participants used Systemic glucocorticoids (SCSs) for CRSwNP |
week0-52
|
|
Proportion of participants who used Antibiotics for CRSwNP at least once
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • Proportion of participants who used Antibiotics for CRSwNP at least once. |
week0-52
|
|
Proportion of participants who used biologics for CRSwNP at least once
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • Proportion of participants who used at least once. |
week0-52
|
|
Proportion of participants who used ICS/LABA for asthma at least once.
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by • Proportion of participants who used at least once. |
week0-52
|
|
Proportion of other related medications used.
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively. |
week0-52
|
|
The proportion of participants requiring surgery within one year and the number of surgery
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively. |
week0-52
|
|
Time to first recurrence
Prazo: week0-52
|
To describe the time to first recurrence and proportion of participants with recurrence |
week0-52
|
|
Proportion of participants with recurrence
Prazo: week0-52
|
To describe the time to first recurrence and proportion of participants with recurrence |
week0-52
|
|
Proportion of participants demonstrating clinically meaningful improvement at Week 52 and Week 4 postoperatively based on: -NCS (MCID relative to pre-operative of -1.0)
Prazo: week0-52
|
To describe the proportion of post-operative participants demonstrating clinically meaningful improvement at Week-52 and Week-4 |
week0-52
|
|
Proportion of participants demonstrating clinically meaningful improvement at Week 52 and Week 4 postoperatively based on: - SNOT-22 total score (with a Minimum Clinically Important Difference (MCID) relative to pre-operative of -8.9)
Prazo: week0-52
|
To describe the proportion of post-operative participants demonstrating clinically meaningful improvement at Week-52 and Week-4 [SNOT-22: score 0-5 for each item, 5 means worse outcome] |
week0-52
|
|
Proportion of participants demonstrating clinically meaningful improvement at Week 52 and Week 4 postoperatively based on: - VAS for nasal blockage item (MCID relative to pre-operative of -3)
Prazo: week0-52
|
To describe the proportion of post-operative participants demonstrating clinically meaningful improvement at Week-52 and Week-4 [VAS scale: 0-10,10 means worse outcome] |
week0-52
|
|
The proportion of participants with post-operative complications
Prazo: week0-52
|
Post-operative complications by •The proportion of participants with complications. |
week0-52
|
|
Changes from baseline at each collection point: Spirometry (pre-BD FEV1)
Prazo: baseline-week52
|
To describe asthma-related outcomes (for asthma participants only) |
baseline-week52
|
|
Changes from baseline at each collection point: Asthma Control Questionnaire-5(ACQ-5)
Prazo: baseline-week52
|
To describe asthma-related outcomes (for asthma participants only) [ACQ-5: score 0-6 for each item, 6 means worse outcome] |
baseline-week52
|
|
Pre-operative, 24-week post-operatively, and 52-week ethmoid/maxillary sinuses (E/M) ratio
Prazo: week0-52
|
To describe the changes in post-operative ethmoid/maxillary sinuses (E/M) ratio. |
week0-52
|
|
Pre-operative, 24-week post-operatively, and 52-week Olfactory Cleft Scores(NCS)
Prazo: week0-52
|
To describe the changes in post-operative Olfactory Cleft Scores(NCS). [NCS: score 0-3, 3 means worse outcome] |
week0-52
|
|
The number of days of use intranasal corticosteroids (INCS).
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by the number of days of use intranasal corticosteroids (INCS). |
week0-52
|
|
The proportion of participants who used Systemic glucocorticoids (SCSs) for CRSwNP
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • Proportion of participants who used Systemic glucocorticoids (SCSs) for CRSwNP at least once. |
week0-52
|
|
Number of days of treatment with Systemic glucocorticoids (SCSs) for CRSwNP.
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • The number of use days that participants used Systemic glucocorticoids (SCSs) for CRSwNP. |
week0-52
|
|
The proportion of participants who used Systemic glucocorticoids (SCSs) for asthma
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • Proportion of participants who used Systemic glucocorticoids (SCSs) for asthma at least once. |
week0-52
|
|
The daily dosage of participants used Systemic glucocorticoids (SCSs) for asthma
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • The daily dosage (convert according to the equivalent dose of prednisone.) of participants used Systemic glucocorticoids (SCSs) for asthma |
week0-52
|
|
Number of days of treatment with Systemic glucocorticoids (SCSs) for asthma.
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • The number of use days that participants used Systemic glucocorticoids (SCSs) for asthma. |
week0-52
|
|
Number of days of treatment with Antibiotics for CRSwNP
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • The number of use days. |
week0-52
|
|
Proportion of participants who used Antibiotics for asthma at least once
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • Proportion of participants who used Antibiotics for asthma at least once. |
week0-52
|
|
Number of days of treatment with Antibiotics for asthma
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • The number of use days. |
week0-52
|
|
Number of days of treatment with ICS/LABA for asthma
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by • The number of use days. |
week0-52
|
|
Proportion of participants who used ICS/LABA/LAMA for asthma at least once.
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by • Proportion of participants who used at least once. |
week0-52
|
|
Number of days of treatment with ICS/LABA/LAMA for asthma
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by • The number of use days. |
week0-52
|
|
The types of post-operative complications
Prazo: week0-52
|
Post-operative complications by •The types of post-operative complications. |
week0-52
|
|
The number of post-operative complications occurrences.
Prazo: week0-52
|
Post-operative complications by •The number of complication occurrences. |
week0-52
|
|
Proportion of participants who used biologics for asthma
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • Proportion of participants who used at least once. |
week0-52
|
|
The frequency of use biologics for CRSwNP
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • The frequency of use. |
week0-52
|
|
The frequency of use biologics for asthma
Prazo: week0-52
|
To describe the post-operative medication use and need for surgery within one year post-operatively by: • The frequency of use. |
week0-52
|
Outras medidas de resultado
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
T2:bEOS≥150 cells/μL or Tissue EOS≥10/hpf or Total IgE≥100 IU/ml.
Prazo: Baseline
|
Proportion of different inflammatory subtype at baseline. |
Baseline
|
|
bEOS: <150,150-300,≥300 cells/μL.
Prazo: Baseline
|
Proportion of different inflammatory subtype at baseline. |
Baseline
|
|
Tissue EOS≥10/hpf.
Prazo: Baseline
|
Proportion of different inflammatory subtype at baseline. |
Baseline
|
|
Total IgE≥100 IU/ml.
Prazo: Baseline
|
Proportion of different inflammatory subtype at baseline. |
Baseline
|
|
Baseline characteristics of patients with recurrence.
Prazo: Baseline
|
Explore the characteristics/markers of recurrence within 1 year post-operate: such as gender, age, comorbidities (allergic rhinitis, asthma, NSAID-exacerbated respiratory disease, dermatitis/eczema, COPD, somnipathy etc.), phenotype, pre-operative scores, tissues (eosinophils (count: n/HPF; percentage: %), neutrophils (n/HPF; %) IL-4, IL-5, IL-13, IL-33, IL-17, TNF-α, IFN-γ,IL-25, TGF-β and TSLP ), serum (total IgE and specific IgE (IU/mL), ECP), blood (eosinophils (count: 10^9/L; percentage: %), basophils (10^9/L; %), neutrophils (10^9/L; %), monocytes (10^9/L; %), lymphocytes (10^9/L; %)) and S. aureus abundance |
Baseline
|
|
Differences in characteristics between patients with clinically meaningful improvement and those without at week-52 and week-4 after surgery.
Prazo: week-52, week-4
|
Explore the baseline characteristics and biomarkers related to surgical prognosis of patients:such as gender, age, comorbidities, phenotype, pre- operative scores, S. aureus abundance, different markers in nasal secretions, blood, and tissues |
week-52, week-4
|
|
Number of participants with AEs, ADRs, and special situations associated with identified AstraZeneca products used for CRSwNP and/or asthma treatment if any.
Prazo: baseline-week52
|
To summarize adverse events (AEs), adverse drug reactions (ADRs), and special situations associated with identified AstraZeneca products used for CRSwNP and/or asthma treatment, if any. |
baseline-week52
|
|
Proportion of participants with AEs, ADRs, and special situations associated with identified AstraZeneca products used for CRSwNP and/or asthma treatment if any.
Prazo: baseline-week52
|
To summarize adverse events (AEs), adverse drug reactions (ADRs), and special situations associated with identified AstraZeneca products used for CRSwNP and/or asthma treatment, if any. |
baseline-week52
|
|
Days of hospitalization
Prazo: baseline-week52
|
To describe direct Economic Burden. |
baseline-week52
|
|
First aid visits
Prazo: baseline-week52
|
To describe direct Economic Burden |
baseline-week52
|
|
General practitioner visits
Prazo: baseline-week52
|
To describe direct Economic Burden |
baseline-week52
|
|
Ear-nose-throat outpatient department visit
Prazo: baseline-week52
|
To describe direct Economic Burden |
baseline-week52
|
|
Total outpatient department visit
Prazo: baseline-week52
|
To describe direct Economic Burden |
baseline-week52
|
|
Outpatient (Expense per visit, Total expense within 1 year post-operatively)
Prazo: week0-week52
|
To describe Healthcare Related Utilization |
week0-week52
|
|
Emergency (Expense per visit, Total expense within 1 year post-operatively)
Prazo: week0-week52
|
To describe Healthcare Related Utilization |
week0-week52
|
|
Inpatient (Expense per visit, Total expense within 1 year post-operatively)
Prazo: week0-week52
|
To describe Healthcare Related Utilization |
week0-week52
|
|
Pharmacy (Expense per visit, Total expense within 1 year post-operatively)
Prazo: week0-week52
|
To describe Healthcare Related Utilization |
week0-week52
|
|
Work productivity and activity impairment (WPAI)
Prazo: baseline-week52
|
To describe indirect burden |
baseline-week52
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Weiping Wen, Professor, First Affiliated Hospital, Sun Yat-Sen University
- Investigador principal: Dongdong Zhu, Professor, China-Japan Union Hospital, Jilin University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
Outros números de identificação do estudo
- D5242R00005
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Prazo de Compartilhamento de IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Critérios de acesso de compartilhamento IPD
When a request has been approved, AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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