Women who take part in clinical trials gain health benefits even when the treatment is found to be ineffective, according to a new analysis.
Trial participants receive enhanced oversight above and beyond usual care, explained Professor Khalid Khan from Queen Mary University of London, UK, and colleagues in yesterday’s (14 February) BJOG: International Journal of Obstetrics and Gynaecology.
The team say that research on the effect of women’s participation in trials has not been examined thoroughly, as it tends to be unique in many ways: less industry-funded, often focusing on mother and offspring as a single unit, and having social and cultural sensitivities specific to gynaecology "which may predispose participants to benefit or harm in a manner that cannot be surmised from the broad syntheses previously reported."
They carried out a systematic review of 21 studies involving 20,160 women. This showed that participants had 25% better odds of improved health outcomes, compared with non-participants. They add that the benefits were greatest in high quality trials.
Professor Khan said: "Women in general are often unrepresented in research, so we hope this may lead to a shift in attitudes and encourage more clinicians and women to be involved in trials.
"We also hope that patients recognise that research can be even safer than routine healthcare, due to the additional safeguards in place."
However, the team point out that: "It is important to remember that research can still be associated with risk, and it is the duty of researchers and clinicians to inform patients of the potential risk and benefit of engagement in research."
Nijjar, S. K. et al. Participation in clinical trials improves outcomes in women’s health: A systematic review and meta-analysis. BJOG 14 February 2017; doi: 10.1111/1471-0528.14528 [Abstract]
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