Karen Schreiber: The BBQ Trial and the Challenge of Conducting Pregnancy RCTs
Karen Schreiber, Scientific and Clinical Lead at Danish Centre for Expertise in Rheumatology (CeViG) and Danish Hospital for Rheumatic Diseases, shared on LinkedIn about a recent article she and her colleagues co-authored, published in The Lancet, adding:
“We congratulate the Pasquier team for their effort to conduct this investigator iniated clinical trial of hydroxychloroquine (HCQ) versus placebo in pregnant women with unexplained pregnancy loss (BBQ trial).
Pregnancy RCTs are amongst the most challenging RCTs to run. They are complex, expensive, labour intensive and unfortunately often seen as high risk to funders, regulators and ethic boards. But they are necessary.
The BBQ study was prematurely stopped the French regulator due to safety concerns in the treatment arm (they found 2 cases of polydactylia). The independent data and safety monitoring board (IDSMB) concluded that the benefit-risk balance remained acceptable. The study was stopped anyway.
What is left is an unanswered question if HCQ is beneficial in unexplained miscarriages, potential use despite the lack of evidence.
The same happened with heparin years ago.
Women deserve to be protected through research, not from research.
Our The Lancet Obstetrics, Gynaecology, and Women’s Health Comment on the prematurely stopped BBQ HCQ trial shows what happens when risk‑averse decisions shut down carefully monitored pregnancy studies before they can answer crucial questions.
RCTs in pregnancy are not a luxury… they are essential to generate the robust evidence we need to move beyond anecdote, fear and medico‑legal anxiety, and to offer women truly evidence‑based care.
Some of you might have heard me saying this before.
We need to do better.
Urgently.”
1. Title: Protecting women through research, not from research: the BBQ trial
Authors: Karen Schreiber, Christine Graversgaard, Ian A Greere, Beverley J Hunt
2. Title: Hydroxychloroquine for prevention of recurrent miscarriage in France (BBQ): a prospective, multicentre, randomised, placebo-controlled, double-blind, phase 3 trial
Authors: Elisabeth Pasquier, Luc de Saint-Martin, Gisèle Marhic, Grégoire Le Gal, Aurélien Delluc, Céline Pimentel, Arsène Mékinian, Céline Chauleur, Geneviève Plu-Bureau, Caroline Bohec, Florence Bretelle, Norbert Winer, Vincent Poindron, Virginie Cogulet, Francis Couturaud, Dominique Mottier
Read the full article on The Lancet.
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