Morten Asser Karsdal , Lucio C. Rovati , Jeyanesh Tambiah , Olga Kubassova , Christoph Ladel , Francis Berenbaum , Anne-Christine Bay-Jensen , Lachy Mclean , Richard Loeser , Ali Mobasheri , Virginia B. Kraus
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引用次数: 0
摘要
目的炎症内型可以说是骨关节炎(OA)中最成熟的内型之一。虽然内分型有望推动药物开发,但在取得成功的临床结果之前,必须考虑、应对和解决许多潜在的挑战。设计自 2017 年以来,国际骨关节炎研究学会(OARSI)主办了临床试验研讨会(CTS)。每年,OARSI和CTS指导委员会都会鼓励包括监管机构、药物开发商、临床医生、临床研究人员、生物标志物专家和基础科学家在内的广泛利益相关者就选定的主题进行讨论,旨在推动OA领域的药物开发。结果本报告强调了学术界的 "蓝海 "战略与药物开发商的可行性驱动方法之间持续存在的紧张关系,所有这些都是在科学努力寻找有效解决方案的背景下进行的。了解所有利益相关者的需求、目标、制约因素和机遇对于确定最佳的 OA 药物开发战略至关重要。
The inflammatory endotype in osteoarthritis: Reflections from the 2024 OARSI clinical trials symposium (CTS) with a special emphasis on feasibility for clinical development
Objective
The inflammatory endotype is arguably one of the most well-established endotype in osteoarthritis (OA). While endotyping holds promise for advancing drug development, numerous potential challenges must be considered, addressed and resolved before successful clinical outcomes can be achieved.
Design
Since 2017, the Osteoarthritis Research Society International (OARSI) has hosted the Clinical Trials Symposium (CTS). Each year, OARSI and the CTS steering committee encourage discussions on selected topics among a broad range of stakeholders, including regulators, drug developers, clinicians, clinical researchers, biomarker specialists, and basic scientists, with the aim of advancing drug development in the OA field.
Results
This report highlights the ongoing tension between academia's “blue ocean” strategy and the feasibility-driven approach of drug developers, all within the context of scientific efforts to find effective solutions. Understanding the needs, goals, constraints, and opportunities of all involved stakeholders is crucial for defining optimal drug development strategies for OA.
Conclusion
A multidisciplinary, collaborative approach is essential for developing effective OA treatments, balancing scientific discovery with regulatory and clinical feasibility.