Challenges and Opportunities in Statistical Analyses and Designs for Neuroscience Clinical Trials

Abstract

Drug development is a complex, costly, and high-risk process, with neuroscience representing one of the most challenging therapeutic areas due to the complexity of neurodegenerative and neuropsychiatric disorders. Neuroscience clinical trials face unique barriers, making the adoption of innovative statistical methods in study design, execution, and analysis especially critical for improving clarity, feasibility, efficiency, and validity in the drug development process. The ASA Biopharmaceutical Section Neuroscience Scientific Working Group (SWG) was formed to advance statistical research and address these distinct challenges. This landscape paper provides an overview of key challenges and opportunities in statistical methods and trial designs for neuroscience, offering insights to guide future research and practice in this evolving field.

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BibTeX

@misc{jia2026challenges,
  title = {{Challenges and Opportunities in Statistical Analyses and Designs for Neuroscience Clinical Trials}},
  author = {Jia Jia and Man Jin and Bo Lu and Jianchang Lin and Inna Perevozskaya and Hui Yang and Nan Hu and Yi Lu and Qi Q and Jonathan Hartzel and Shouhao Zhou and Shyla Jagannatha and Wei Michelle Zhang},
  howpublished = {arXiv},
  year = {2026},
  month = oct,
  doi = {10.48550/arxiv.2610.20833},
  eprint = {2610.20833},
  archivePrefix = {arXiv},
  url = {https://arxiv.org/abs/2610.20833},
  note = {CC0},
}

RIS

TY  - UNPB
TI  - Challenges and Opportunities in Statistical Analyses and Designs for Neuroscience Clinical Trials
AU  - Jia Jia
AU  - Man Jin
AU  - Bo Lu
AU  - Jianchang Lin
AU  - Inna Perevozskaya
AU  - Hui Yang
AU  - Nan Hu
AU  - Yi Lu
AU  - Qi Q
AU  - Jonathan Hartzel
AU  - Shouhao Zhou
AU  - Shyla Jagannatha
AU  - Wei Michelle Zhang
PY  - 2026
DA  - 2026/10/14
PB  - arXiv
DO  - 10.48550/arxiv.2610.20833
UR  - https://arxiv.org/abs/2610.20833
AB  - Drug development is a complex, costly, and high-risk process, with neuroscience representing one of the most challenging therapeutic areas due to the complexity of neurodegenerative and neuropsychiatric disorders. Neuroscience clinical trials face unique barriers, making the adoption of innovative statistical methods in study design, execution, and analysis especially critical for improving clarity, feasibility, efficiency, and validity in the drug development process. The ASA Biopharmaceutical Section Neuroscience Scientific Working Group (SWG) was formed to advance statistical research and address these distinct challenges. This landscape paper provides an overview of key challenges and opportunities in statistical methods and trial designs for neuroscience, offering insights to guide future research and practice in this evolving field.
ER  -

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