Excluding pregnancy from COVID-19 trials: Protection from harm or the harm of protection?

Affiliations

¹ Maternal-fetal medicine specialist, Mount Sinai Hospital (Sinai Health System), University of Toronto, Toronto, Ont.
² Maternal-fetal medicine physician, Mount Sinai Hospital (Sinai Health System), University of Toronto, Toronto, Ont.

Comment

Ann Kinga Malinowski et al. CMAJ. 2020.

. 2020 Jun 8;192(23):E634.

doi: 10.1503/cmaj.75807.

¹ Maternal-fetal medicine specialist, Mount Sinai Hospital (Sinai Health System), University of Toronto, Toronto, Ont.
² Maternal-fetal medicine physician, Mount Sinai Hospital (Sinai Health System), University of Toronto, Toronto, Ont.

No abstract available

Conflict of interest statement

Competing interests: None declared.

Generating randomized trial evidence to optimize treatment in the COVID-19 pandemic.
Cheng MP, Lee TC, Tan DHS, Murthy S. Cheng MP, et al. CMAJ. 2020 Apr 14;192(15):E405-E407. doi: 10.1503/cmaj.200438. Epub 2020 Mar 26. CMAJ. 2020. PMID: 32336678 Free PMC article. No abstract available.

1. Cheng MP, Lee TC, Tan DHS, et al. Generating randomized trial evidence to optimize treatment in the COVID-19 pandemic. CMAJ 2020;192:E405–7. - PMC - PubMed
1. ClinicalTrials.gov. 31 Studies found for: pregnancy, COVID. Available: https://clinicaltrials.gov/ct2/results?cond=COVID&term=pregnancy&cntry=&... (accessed 2020 14 May).
1. Park SS, Grayson MH. Clinical research: protection of the “vulnerable”? J Allergy Clin Immunol 2008; 121:1103–7. - PubMed
1. Ethics of research in pregnancy, Buenos Aires, Argentina, 3 and 4 November 2016 [meeting report]. Global Forum on Bioethics Research; 2017. Available: www.gfbr.global/wp-content/uploads/2017/04/GFBR-2016-report-ethics-of-re... (accessed 2020 Apr. 25).
1. Considerations for inclusion of women in clinical trials and analysis of sex differences [guidance document]. Ottawa: Health Canada; 2013, updated 2013, Dec. 10. Available: www.canada.ca/en/health-canada/services/drugs-health-products/drug-produ....