Patient and Public involvement in the design of an international clinical trial: Real world experience

Gwenda Simons, Helen Jones, Ian Clarke, Firoza Davies, Stacey Grealis, Elspeth Insch, Hameed Kahn, Joanne Lloyd, Al Richards, Hayley Rose, Ruth Williams, Maarten de Wit, Clarissa Woodcock, Leigh Romaniuk, Michelle Bardgett, Arthur G Pratt, Marie Falahee
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Abstract

Background The value of patient and public involvement (PPI) during the earliest stages of clinical trial development, and prior to the award of substantive funding, is widely recognised. However, it is often under resourced and PPI processes during this phase are rarely reported in detail. Having benefitted from seed funding to develop an international clinical trial proposal, we sought to describe and appraise PPI activities and processes that support pre-award co-development.
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患者和公众参与国际临床试验的设计:真实世界的经验
背景 在临床试验开发的最初阶段和获得实质性资助之前,患者和公众参与(PPI)的价值已得到广泛认可。然而,这一阶段的患者和公众参与往往资源不足,也很少有详细报道。在获得种子基金以开发国际临床试验提案后,我们试图描述和评估支持获奖前共同开发的 PPI 活动和流程。
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