The RECOVERY trial pregnancy leads from the National Perinatal Epidemiology Unit at the University of Oxford and King’s College London, along with researchers who led the trial at the University of Oxford and a public representative have described how RECOVERY successfully enabled the participation of pregnant women in the search for an effective treatment for COVID-19. The group have highlighted the need for improved inclusion of pregnant women in clinical trials in an analysis piece published in The BMJ.
In the article, the researchers consider the barriers that stop pregnant women from being able to participate in clinical trials and how to address them to increase access to safe and effective treatments and reduce inequity.
Key messages:
- The safety and efficacy of most drugs during pregnancy is unclear because of the exclusion of pregnant women from trials and because robust pregnancy follow-up studies are not conducted after the drug has been licensed;
- Concerns about fetal safety have outweighed consideration of the benefits of equitable access and better information for clinical decisions during pregnancy;
- The RECOVERY trial has shown that clinicians are willing to include pregnant women in trials and that pregnant women are willing to participate;
- Barriers to inclusion of pregnant women in therapeutic trials are mostly related to sponsors, regulators, and insurers;
- Regulatory incentives to ensure that pregnant women are included in therapeutic and preventive trials by default are urgently needed.
Marian Knight, Professor of Maternal and Child Population Health at Oxford Population Health’s National Perinatal Epidemiology Unit, and senior author of the paper said ‘Pregnant women are at higher risk from COVID-19; without their inclusion in RECOVERY we would have had no information about treatments that were suitable for them.
‘The recruitment rate among pregnant women was comparable to that for all other eligible participants, suggesting that barriers to participation in other trials are the result of processes rather than individual decisions. We hope that the mechanisms that we employed in RECOVERY to ensure the inclusion of pregnant women can be adopted in other trials to reduce the inequity in treatment often encountered during pregnancy.’