Tolppa Timo, Hussaini Arishay, Ahmed Nikhat, Dondorp Arjen M, Farooq Shehla, Khan Monaza, Masood Adnan, Murthy Srinivas, Saleem Saima, Shuja Zahyd, Zaman Shahnaz, Hashmi Madiha
Department of Experimental Medicine, University of British Columbia, 2775 Laurel Street, Vancouver, BC, V5Z 1M9, Canada.
Ziauddin University, Karachi, Pakistan.
Res Involv Engagem. 2024 Sep 27;10(1):98. doi: 10.1186/s40900-024-00635-6.
Patient and public involvement and engagement (PPIE) in clinical trials is increasingly recognized as vital for ensuring research relevance and accessibility. Despite its proven benefits, PPIE remains limited, particularly in low- and middle-income countries, and more examples of effective strategies for involvement are needed. This commentary outlines the establishment of a PPIE group for clinical trials in a lower-middle-income country setting with limited research infrastructure.
We established Pakistan's first ever PPIE group for clinical trials within a new clinical trials unit at Ziauddin University in Karachi. The objectives of our project were focused on group formation, redesign of informed consent documents for trials, and dissemination of trial results to the public. Recruitment strategies involved referrals from clinicians and existing collaborators as well as engagement at public events, distribution of advertising leaflets and social media posts. Ten potential members were selected based on motivation, commitment and ability to contribute critically, with six members continuing their involvement long-term. An existing tool designed to establish the access needs of public partners was adapted to our project to help us document and account for members' expectations and support requirements. The process of using the tool enabled deep engagement, clarified roles, and fostered trust between coordinators and group members. Patient and public members gained confidence about the legitimacy of the project and felt more comfortable participating in the first group meeting. Lessons learned emphasize the importance of wide-ranging engagement efforts and transparent discussions about expectations to build effective collaborative relationships.
Our experience demonstrates the feasibility of establishing a PPIE group for clinical trials in Pakistan and highlights strong public interest for research involvement. The use of a formal tool to document needs, prior experiences and expectations encouraged relationship-building and helped coordinators make relevant accommodations for members. This account contributes to the growing body of literature on effective PPIE practices, emphasizing the value of tailored support and transparent communication in facilitating meaningful public involvement in clinical trials.
患者及公众参与临床试验日益被视为确保研究相关性和可及性的关键。尽管已证明其益处，但患者及公众参与仍很有限，尤其是在低收入和中等收入国家，因此需要更多有效参与策略的实例。本评论概述了在一个研究基础设施有限的中低收入国家背景下，为临床试验建立患者及公众参与小组的情况。
我们在卡拉奇的齐亚丁大学新的临床试验单位内，建立了巴基斯坦首个用于临床试验的患者及公众参与小组。我们项目的目标集中在小组组建、重新设计试验知情同意文件以及向公众传播试验结果。招募策略包括临床医生和现有合作者的推荐，以及在公共活动中的参与、发放广告传单和社交媒体发帖。根据积极性、投入度和批判性贡献能力挑选了10名潜在成员，其中6名成员长期参与。一个旨在确定公共合作伙伴获取需求的现有工具被应用于我们的项目，以帮助我们记录和考虑成员的期望及支持需求。使用该工具的过程促进了深度参与、明确了角色，并增进了协调员与小组成员之间的信任。患者和公众成员对项目的合法性更有信心，并且在首次小组会议中参与时感觉更自在。吸取的经验教训强调广泛参与努力以及关于期望的透明讨论对于建立有效合作关系的重要性。
我们的经验证明了在巴基斯坦为临床试验建立患者及公众参与小组的可行性，并凸显了公众对参与研究的浓厚兴趣。使用正式工具记录需求、既往经历和期望促进了关系建设，并帮助协调员为成员做出相关调整。本报告为关于有效患者及公众参与实践的文献不断增多做出了贡献，强调了量身定制的支持和透明沟通在促进公众有意义地参与临床试验方面的价值。
