Emerging clinical initiatives in pharmaceutical development: methodology and regulatory perspectives

J Biopharm Stat. 2022 May 4;32(3):357-358. doi: 10.1080/10543406.2022.2080699. Epub 2022 Jun 10.

Authors

Nelson Lu¹, Herbert Pang²

Affiliations

¹ Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
² PD Data Sciences, Genentech, South San Francisco, California, USA.

PMID: 35687486
DOI: 10.1080/10543406.2022.2080699

No abstract available

Keywords: External data; Patient-centric trials; complex innovative designs; conditional power; digital health; statistical learning.

MeSH terms

Drug Approval* / methods
Humans
Pharmaceutical Preparations
Research Design*

Substances

Pharmaceutical Preparations