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Post trial access related in-depth interviews (IDIs) with key informants and focus group discussion (FGDs) with patients

To explore the experience, roles, responsibilities, perceptions, challenges and expectations of stakeholders on Post-Trial Access (PTA) during epidemic/pandemic

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/03/063441
Enrollment
840
Registered
2024-03-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

None listed

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: Willing to give written informed consent or verbal consent in case the interviews are conducted online [for example with sponsors and regulators] Pharmaceutical Sponsors /CROs, researchers, regulators and ethics committee members who are willing to give consent for the interview and who were involved in any manner with at least one study during the COVID -19 pandemic. Covid-19 patients/ vaccine/ investigational product recipients.

Exclusion criteria

Exclusion criteria: Stakeholders in Non COVID -19 studies conducted during the pandemic

Design outcomes

Primary

MeasureTime frame
Understanding perceptions, challenges, benefits of PTA amongst the various stakeholdersTimepoint: 1 year—

Secondary

MeasureTime frame
Understanding experiences of PTA beneficiaries in terms of benefits, challenges and expectationsTimepoint: 1 year—

Countries

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

Contacts

Public ContactDr Roopa Parida

Seth GSMC and KEMH Mumbai

dr.roopaparida@gmail.com8743907794

Outcome results

None listed

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