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Post-Trial Provisions in clinical studies on pandemics: a scoping review

Developing national and global agendas for the ethics of post-trial arrangements [PTA] in low and middle income countries [LMICs] during pandemics/epidemics - Pandemic Ethics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/12/060546
Enrollment
1000
Registered
2023-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B20- Human immunodeficiency virus [HIV]disease Health Condition 2: B348- Other viral infections of unspecified site

Interventions

Intervention1: Not applicable: Not applicable Control Intervention1: Not applicable: Not applicable

Sponsors

University of Oslo The Research Council of Norway
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Population Clinical trials in literature related to HIV, Ebola, and COVID-19 conducted in Brazil, India, Kenya, Nepal, the Philippines, and Tanzania in the selected areas Intervention Clinical trials evaluating interventions for prevention, treatment, or management of HIV, Ebola, or COVID19 Outcomes Those studies that provide data on post-trial arrangements, nature of these arrangements, including participant follow up, and access to treatment, data sharing, community engagement Study designs Randomized controlled trials, observational studies, and qualitative studies. Any and all designs will be taken into consideration

Exclusion criteria

Exclusion criteria: Studies not related to HIV, Ebola, or COVID-19; Studies conducted outside the specified countries;

Design outcomes

Primary

MeasureTime frame
Available scientific and grey literature publications on PTA with regards to COVID-19 clinical trials, HIV and Ebola in LMICs Timepoint: 1 year

Secondary

MeasureTime frame
Available government, relevant NGOs, and patient social media sites where policies or information on PTA has been posted and review comments from the publicTimepoint: 1 year;Available laws, regulations, policies, and norms on PTA in the 6 LMICs countriesTimepoint: 1 year;Available newspaper and social media articles in the past 10 years on PTA in the 5 LMICs countriesTimepoint: 1 year

Countries

Brazil, India, Kenya, Nepal, Norway, Philippines, Tanzania

Contacts

Public ContactDr Vijaya Sandeep Gunjal

Seth GSMC and KEMH Mumbai

vijugmc@yahoo.co.in8097092722

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026