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Abstract：
Background Clinical research presents a promising path for improving healthcare in contemporary India. Yet, researchers identify gaps in trust, awareness, as well as misconceptions about being a \'\"guinea pig.\" We proposed building the capacity of training patient advocacy groups (PAGs) in patient-centered clinical research and through them creating aware patients as research partners. Methodology Patient Advocates for Clinical Research (PACER) is a tiered program to share information and education about clinical research with PAGs. Tier one is a self-paced online learning course, followed by workshops on clinical research, Good Clinical Practice, research consent, case studies, and group discussions. Results A total of 20 PAGs represented by 48 participants, active in areas of pediatric cancer, breast cancer, multiple myeloma, type I diabetes, spinal muscular atrophy, sickle cell disease, and inflammatory bowel diseases, participated. Among 48 participants 30 successfully completed the online course (multiple-choice question evaluation score cut-off >70%), attaining an average score of 23.9 ± 2.1 out of 30. Overall, 48 participants attended workshop 1 and 45 workshop 2, with 140 participants joining the focus group discussion (FGD). An overall improvement of 9.4% (𝜒2 = 46.173; p < 0.001) for workshop 1 and 8.2% (𝜒2 = 25.412; p < 0.001) for workshop 2 was seen in knowledge gain about clinical research. The FGD raised issues such as misleading information from research teams, unethical recruitment, incomprehensible information sheets, and limited trial-related knowledge fostering fear of participation in clinical research. Conclusions Multimodal and tiered learning of clinical research such as that used by PACER has a good participatory and learning response from PAGs and may be further explored.
摘要：
背景临床研究为改善当代印度的医疗保健提供了一条有希望的途径。然而，研究人员发现信任中的差距，意识,以及关于成为“豚鼠”的误解。“我们建议在以患者为中心的临床研究中建立培训患者倡导团体（PAG）的能力，并通过他们创造有意识的患者作为研究伙伴。方法学患者临床研究倡导者（PACER）是一个分层计划，旨在与PAG共享有关临床研究的信息和教育。第一层是一个自定进度的在线学习课程，随后是临床研究研讨会，良好的临床实践,研究同意书,案例研究,和小组讨论。结果48名参与者共20个PAG，活跃于儿科癌症领域，乳腺癌,多发性骨髓瘤,I型糖尿病,脊髓性肌萎缩症,镰状细胞病,和炎症性肠病，参与。在48名参与者中，有30名成功完成了在线课程（多项选择题评估得分截止>70％），30分中的平均得分为23.9±2.1分。总的来说,48名参与者参加了第1班和第45班，有140名参与者参加了焦点小组讨论（FGD）。关于临床研究的知识增加，车间1的总体提高了9.4％（？2=46.173；p<0.001），车间2的总体提高了8.2％（？2=25.412；p<0.001）。烟气脱硫引发了研究团队的误导性信息等问题，不道德的招聘，难以理解的信息表，和有限的试验相关知识助长了对参与临床研究的恐惧。结论PACER使用的临床研究的多模式和分层学习具有良好的参与和学习反应，可以进一步探索。
