Are VWD Clinical Trials Missing What Matters Most to Women? – RPTH
RPTH Journal shared on LinkedIn about a recent article by Meaghan O’Donnell et al, adding:
”Are we overlooking what matters most to women with von Willebrand disease?
Heavy menstrual bleeding (HMB) is the most common and often the most severe bleeding symptom in women with von Willebrand disease (VWD).
Yet a review of interventional VWD prophylaxis trials found that menstrual outcomes remain strikingly underrepresented in study design and reporting.
Among 10 eligible clinical trials, only 2 (20%) incorporated menstrual-related inclusion criteria, while 4 (40%) specifically excluded treated menstrual bleeding from bleed eligibility criteria.
Although 80% of studies measured annualized bleeding rates, only 40% collected menstrual outcomes, highlighting a disconnect between trial endpoints and the experiences of many patients.
The authors argue that VWD trials have largely adopted outcome measures designed for hemophilia, rather than focusing on female-specific bleeding.
They call for future studies to incorporate menstrual outcomes, improve reporting of women of reproductive age, and ensure clinical trial design better reflects the needs of people living with VWD.”
Title: Menstrual outcomes are frequently overlooked in von Willebrand disease trials
Authors: Meaghan O’Donnell, Claire Kelly, Rezan Abdul Kadir, Roseline D’Oiron, Petra Elfvinge, Gaby Golan, Keith Gomez, Samantha C. Gouw, Laura Quintas, Karin P.M. van Galen, Michelle Lavin
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