Women’s Representation in RCTs Evaluating FDA-Supervised Medical Devices-Reference-Cited by-同舟云学术

Women’s Representation in RCTs Evaluating FDA-Supervised Medical Devices

Published:2024-08-01 Issue:8 Volume:184 Page:977
ISSN:2168-6106
Container-title:JAMA Internal Medicine
language:en
Short-container-title:JAMA Intern Med

Author:

Epstein Nitzan Karny¹²,Harpaz Maya³,Abo-Molhem Mohamad³,Yehuda Daniel³,Tau Noam²⁴,Yahav Dafna²⁵

Affiliation:

1. Infectious Diseases Unit, Meir Hospital, Kfar-Saba, Israel

2. Faculty of Medicine, Tel-Aviv University, Ramat-Aviv, Tel-Aviv, Israel

3. Internal Medicine B, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel

4. Department of Diagnostic Imaging, Sheba Medical Center, Ramat-Gan, Israel

5. Infectious Diseases Unit, Sheba Medical Center, Ramat-Gan, Israel

Abstract

This systematic review evaluates the representation of women in randomized clinical trials (RCTs) of US Food and Drug Administration (FDA)–supervised medical devices.

Publisher

American Medical Association (AMA)

Link

https://jamanetwork.com/journals/jamainternalmedicine/articlepdf/2819822/jamainternal_epstein_2024_ld_240006_1722366207.78995.pdf

Reference6 articles.

1. Participation of women in clinical trials supporting FDA approval of cardiovascular drugs.;Scott;J Am Coll Cardiol,2018

2. Temporal trends of women enrollment in major cardiovascular randomized clinical trials.;Gong;Can J Cardiol,2019

3. Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices.;Dhruva;Circ Cardiovasc Qual Outcomes,2011

4. Gender gap in leadership of clinical trials.;Waldhorn;JAMA Intern Med,2023

5. Health? C, Program? W, September? SP. CDRH health of women program: strategic plan, January 2022. Accessed May 13, 2022. https://www.fda.gov/about-fda/center-devices-and-radiological-health/cdrh-health-women-program

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1. Representation of women in randomized controlled trials of novel antidiabetic drugs: A cohort study;Diabetes, Obesity and Metabolism;2024-09-12

2. Prioritizing Women’s Inclusion in Clinical Trials of Medical Devices;JAMA Internal Medicine;2024-08-01