Can we justify the under-representation of pregnant women in clinical trials?

We will discuss “The pregnant women as a drug orphan: a global survey of registered clinical trials of pharmacological interventions in pregnancy.” by Scaffidi and co-workers from 29 June 2016 for 7 days.

*This paper is now free-to-view!

We are now on LinkedIn too: http://linkd.in/1BVrpad (simply ask to join)!

Start date: 29 June (the discussion will open for 7 days between 29 June to 6 July 2016)

First hosted discussion session(s) on Twitter starts at: GMT+1 (British Summer Time) 8pm (using hashtag #BlueJC)

Host: @BlueJCHost

Platforms: Twitter, Facebook and LinkedIn 

BJOG_BlueJC_160x600WebBanner_Mar15_(reoriented)_3The Blue Journal Club is an international journal club on women’s health research based on Twitter (as @BlueJCHost). We start our conversation on the last Wednesday of every month and use the hashtag #BlueJC for our tweets. Simply add this hashtag (“#BlueJC”) to each tweet and we will capture it. Each #BlueJC opens for 7 days with an advertised start time. All BJOG #BlueJC papers also have complementary slide sets suitable for face-to-face journal clubs with your local colleagues. You can access the slide set of this paper here (click on the “supporting information” tab).

The discussion points are attached below (quoted from the published Journal Club guide)

Scenario

A young woman attends a multidisciplinary clinic for prenatal counseling. She has been on sodium valproate for her epilepsy since she was a teenager. She has no other medical concerns. She asks, “is my medication going to harm my baby?”  How would you counsel this woman?

Description of research

Participants Pregnant women
Intervention Participation in drug trials during pregnancy
Comparison Not applicable
Outcomes The numbers, location, funding sources, and areas of interest/development of pregnancy drug trials (PDTs)
Study design Comprehensive analysis of sixteen WHO-certified clinical trial registries
Authors’ conclusion Pregnant women are significantly under-represented in global clinical drug trials

Discussion Points

  • How do health professionals determine whether a drug is safe to use during pregnancy?
  • What are the barriers to the inclusion of women in pharmacological interventional trials during pregnancy?
  • What are the potential benefits of including women in pharmacological interventional trials during pregnancy?
  • In figure 1, which medical conditions had the highest number of pregnancy-related drug trials?
  • Which factors may have contributed to the emphases on the above conditions?
  • Which factors may have contributed to the geographic distribution of pregnancy-related drug trials (see the results section)?
  • Suggest one pregnancy-related drug trial that would be the most relevant, acceptable and safe.
  • What could be done to improve the current under-representation of pregnant women in clinical trials?

Suggested reading

  • Quinn SC, Butler J 3rd, Fryer CS, Garza MA, Kim KH, Ryan C, Thomas SB. Attributes of researchers and their strategies to recruit minority populations: results of a national survey. Contemp Clin Trials. 2012 Nov;33(6):1231-7.
  • Legro RS. Barriers to conducting clinical research in reproductive medicine: United States of America. Fertil Steril. 2011 Oct;96(4):817-9.
  • Milliez J. Just inclusion of women of reproductive age in research: FIGO Committee for the Ethical Aspects of Human Reproduction and Women’s Health. Int J Gynaecol Obstet. 2009 Nov;107(2):168.

For those who want to understand hashtags, this may be a useful guide. For an introduction to #BlueJC, please refer to BJOG 2013;120:657–60. Follow @BlueJCHostthis blog and our Facebook page to receive news about #BlueJC.