Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Aug 1:408:132138.
doi: 10.1016/j.ijcard.2024.132138. Epub 2024 May 3.

Negative selection bias for women inclusion in a clinical trial

Antonio Landi  1 , Dik Heg  2 , Enrico Frigoli  3 , Helen Routledge  4 , Fazila-Tun-Nesa Malik  5 , Suzanne Pourbaix  6 , Mirvat Alasnag  7 , Pieter C Smits  8 , Marco Valgimigli  9
Affiliations
Free article
Randomized Controlled Trial

Negative selection bias for women inclusion in a clinical trial

Antonio Landi et al. Int J Cardiol. .
Free article

Abstract

Introduction: Despite the growing awareness towards the importance of adequate representation of women in clinical trials among patients treated with percutaneous coronary intervention (PCI), available evidence continues to demonstrate a skewed distribution of study populations in favour of men.

Methods and results: In this pre-specified analysis from the MASTER DAPT screening log and trial, we aimed to investigate the existence of a negative selection bias for women inclusion in a randomized clinical trial. A total of 2847 consecutive patients who underwent coronary revascularization across 65 participating sites, during a median of 14 days, were entered in the screening log, including 1749 (61.4%) non-high bleeding risk (HBR) and 1098 (38.6%) HBR patients, of whom 109 (9.9%) consented for trial participation. Female patients were less represented in consented versus non-consented HBR patients (22% versus 30%, absolute standardized difference: 0.18) and among non-consented eligible versus consented eligible patients (absolute standardized difference 0.14). The observed sex gap was primarily due investigators' choice not to offer study participation to females because deemed at very high risk of bleeding and/or ischemic complications, and only marginally to a slightly higher propensity of females compared to males to refuse study participation.

Conclusions: Female HBR patients undergoing PCI are less prevalent, but also less likely to participate in the trial than male patients, mainly due to investigators' preference.

Keywords: Gender bias; High bleeding risk; Percutaneous coronary intervention; Selection bias.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest D.H. is with DCR Bern, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, DCR Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. For an up-to-date list of CTU Bern's conflicts of interest see http://www.ctu.unibe.ch/research/declaration_of_interest/index_eng.html. P.C.S. reports personal consulting or speaking fees from Terumo, Abiomed and Opsense; grants and personal consulting fees from Abbott Vascular, Microport and Daichy Sankyo; and grants from SMT. M.V. received grants and/or personal fees from Abbott, Alvimedica/CID, AstraZeneca, Bayer, Biotronik, Bristol Myers Squibb, Chiesi, CoreFLOW, Daiichi-Sankyo, Department Klinische Forschung of Universität Basel, Health Life, Idorsia Pharmaceuticals, Medscape, Miracor, Novartis, Radcliffe, Terumo, Vesalio, outside the submitted work. All other authors declare no competing interests.

Publication types