Department of Neurosurgery, Cancer Biology and Genetics program, Sloan Kettering Institute, New York, NY 10075, USA.
Department of Clinical Neuroscience, John van Geest Centre for Brain Repair and Wellcome-MRC Stem Cell Institute, University of Cambridge, Cambridge, UK.
Cell Stem Cell. 2024 Feb 1;31(2):158-160. doi: 10.1016/j.stem.2023.12.004.
Sham surgery is often required for cell therapies adopting a randomized placebo-controlled double-blinded trial design. Using the case of dopamine neuron therapy for Parkinson's disease, we argue that alternative trial designs should be considered instead, for several reasons relating to ethics, patient burden, ease of unblinding, and cost.
假手术通常是采用随机安慰剂对照双盲试验设计的细胞治疗所必需的。以帕金森病多巴胺神经元治疗为例，我们认为出于伦理、患者负担、解盲的容易程度和成本等几个方面的原因，应该考虑替代试验设计。
