Winkler Tobias, Geissler Sven, Maleitzke Tazio, Perka Carsten, Duda Georg N, Hildebrandt Alexander
Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Center for Musculoskeletal Surgery, Berlin, Germany.
Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Julius Wolff Institute, Berlin, Germany.
EFORT Open Rev. 2024 Sep 2;9(9):837-844. doi: 10.1530/EOR-24-0084.
Advanced therapies are expected to play a crucial role in supporting repair after injury, halting the degeneration of musculoskeletal tissue to enable and promote physical activity. Despite advancements, the progress in developing advanced therapies in orthopaedics lags behind specialties like oncology, since innovative regenerative treatment strategies fall short of their expectations in musculoskeletal clinical trials. Researchers should focus on understanding the mechanism of action behind the investigated target before conducting clinical trials. Strategic research networks are needed that not only enhance scientific exchange among like-minded researchers but need to include early on commercial views, companies and venture perspectives, regulatory insights and reimbursement perspectives. Only in such collaborations essential roadblocks towards clinical trials and go-to-patients be overcome.
先进疗法有望在支持损伤后修复、阻止肌肉骨骼组织退化以促进身体活动方面发挥关键作用。尽管取得了进展，但骨科先进疗法的开发进展落后于肿瘤学等专科，因为创新性再生治疗策略在肌肉骨骼临床试验中未达预期。研究人员在进行临床试验前应专注于了解所研究靶点背后的作用机制。需要建立战略研究网络，这不仅能加强志同道合的研究人员之间的科学交流，还需尽早纳入商业观点、公司及风险投资视角、监管见解和报销视角。只有通过此类合作，才能克服临床试验及面向患者过程中的关键障碍。
