跳至主要内容
临床试验/CTRI/2024/03/063441
CTRI/2024/03/063441尚未招募不适用

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

University of Oslo The Research Council of Norway1 个研究点 分布在 1 个国家目标入组 840 人开始时间: 2024年3月15日最近更新:

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

发起方
University of Oslo The Research Council of Norway
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Nithya Gogtay

Seth GSMC and KEMH Mumbai

研究点 (1)

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