To explore the experience, roles, responsibilities, perceptions, challenges and expectations of stakeholders on Post-Trial Access (PTA) during epidemic/pandemic
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- Understanding perceptions, challenges, benefits of PTA amongst the various stakeholders
研究概览
简要总结
Post-trial arrangement [PTA] or post-trial access [PTA] refers to making the intervention that has been studied in the clinical trial/s especially by the pharmaceutical industry available to those who took part in the study or a wider population from which the study participants were drawn. PTA includes many stakeholders and they are - Pharmaceutical Sponsors, investigators and researchers, policy makers, governments, and even trade associations. to include communities, policy makers, governments, and trade associations. Guidelines on PTA are limited especially in LMICs and this study hopes to address this gap. It has been envisaged with the broad aim of understanding how PTA works [or otherwise] in LMICs through qualitative research. The study essentially will use questionnaires to interview the multiple stakeholders listed now either as one on one discussions or focused group discussions. Whatever comes out from these interviews will be “coded†to find “themes†meaning what really do all these stakeholders feel about PTA.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •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.
排除标准
- •Stakeholders in Non COVID -19 studies conducted during the pandemic.
结局指标
主要结局
Understanding perceptions, challenges, benefits of PTA amongst the various stakeholders
时间窗: 1 year
次要结局
- Understanding experiences of PTA beneficiaries in terms of benefits, challenges and expectations(1 year)
研究者
Dr Nithya Gogtay
Seth GSMC and KEMH Mumbai
