INCLEN Trust International, New Delhi, India Correspondence to: Dr Manoja Kumar Das, Director Projects, The INCLEN Trust International, F1/5, Okhla Industrial Area, Phase 1, New Delhi 110 020.
Indian Pediatr. 2022 Jul 15;59(7):571-579. Epub 2022 Jan 5.
Multicenter studies are essential in clinical and public health research with several advantages compared to single-center studies. Multicenter studies are attractive and advantageous, allowing quicker recruitment, diverse population coverage and increased generalizability. However, these studies often suffer from methodological, implementation and statistical challenges that can compromise the validity of the study. To meet the technical and interpretative integrity, a multicenter study must be conducted with sound study design, uniform implementation methodology, assured standardization, high-quality data and appropriate statistical considerations. A systematic site selection, rigorous study protocols, stringent quality assurance measures and appropriate analytical approach are indispensable to ensure high internal validity and minimize inter-site variability. For effective implementation of multicenter study, a well-organized coordination center and functional governance mechanism are critical. Transparent and effective network communication among the investigators with cultural sensitivities assists in building productive collaboration. This manuscript summarizes the design, organization, implementation and governance aspects of multicenter studies.
多中心研究在临床和公共卫生研究中至关重要，与单中心研究相比具有多项优势。多中心研究具有吸引力和优势，能够更快地招募参与者、覆盖更多样化的人群，并提高研究的普遍性。然而，这些研究常常面临方法学、实施和统计方面的挑战，这些挑战可能会影响研究的有效性。为了保持技术和解释上的完整性，多中心研究必须采用合理的研究设计、统一的实施方法、可靠的标准化、高质量的数据和适当的统计考虑。系统的站点选择、严格的研究方案、严格的质量保证措施和适当的分析方法对于确保高内部有效性和最小化站点间变异性是不可或缺的。为了有效地实施多中心研究，一个组织良好的协调中心和功能治理机制至关重要。调查人员之间透明有效的网络沟通以及文化敏感性有助于建立富有成效的合作。本文总结了多中心研究的设计、组织、实施和治理方面。
