Endpoints and estimands: understanding trials of weight-loss drugs

Affiliations

Comment

Amanda I Adler. Nat Med. 2022 Oct.

. 2022 Oct;28(10):2005-2006.

doi: 10.1038/s41591-022-02032-6.

¹ Diabetes Trial Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, UK. amanda.adler@dtu.ox.ac.uk.

No abstract available

Comment on

Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial.
Garvey WT, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jódar E, Kandler K, Rigas G, Wadden TA, Wharton S; STEP 5 Study Group. Garvey WT, et al. Nat Med. 2022 Oct;28(10):2083-2091. doi: 10.1038/s41591-022-02026-4. Epub 2022 Oct 10. Nat Med. 2022. PMID: 36216945 Free PMC article. Clinical Trial.

1. Patel, M. R., Donahue, M., Wilson, P. W. & Califf, R. M. Am. Heart J. 151, 633–642 (2006). - DOI
1. US Department of Health and Human Services Food and Drug Administration. https://www.fda.gov/media/71252/download (2007).
1. Garvey, W. et al. Nat. Med. https://doi.org/10.1038/s41591-022-02026-4 (2022). - DOI - PubMed
1. US Department of Health and Human Services Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents... (2017).
1. European Medicines Agency Committee for Medicinal Products for Human Use. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e9-r1-ad... (2020).