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Global insight into rare disease and orphan drug definitions: a systematic literature review.
BMJ Open
January 2025
Centre for Public Health, Institute of Clinical Sciences B, Royal Victoria Hospital, Queen's University Belfast School of Medicine, Dentistry and Biomedical Sciences, Belfast, UK.
Objectives: This study sheds light on the available global definitions, classifications, and criteria used for rare diseases (RDs), ultrarare diseases (URDs), orphan drugs (ODs) and ultraorphan drugs (UODs) and provides insights into the rationale behind these definitions.
Design: A systematic literature review was conducted to identify existing definitions and the criteria used to define RDs, ODs and their subtypes.
Data Sources: Searches were performed in the PubMed/Medline, Embase, Scopus and Web of Science (Science and Social Sciences Citation Index) databases covering articles published from 1985 to 2021.
Racial and ethnic enrollment disparities in clinical trials leading to FDA approvals for gynecologic malignancies.
Am J Obstet Gynecol
January 2025
Division of Gynecologic Oncology, Mount Sinai Medical Center, Miami Beach, Florida, USA.
Background: Black women and other minorities have higher age adjusted incidence risk for cervical and endometrial cancer than White women. However, the extent of racial and ethnic disparities in clinical trial enrollment among studies performed mainly in North America and Europe for gynecologic malignancy is unknown.
Objective: This study analyzed enrollment rates by race/ethnicity in trials that led to Food and Drug Administration (FDA) approvals for gynecological cancers from 2010 to 2024.
Association between prenatal depressive symptoms and receipt of recommended maternal and infant care postpartum.
J Affect Disord
January 2025
Department of Social and Behavioral Sciences, Yale School of Public Health, New Haven, CT 06510, USA; Center for Methods in Implementation and Prevention Sciences, Yale University, New Haven, CT 06510, USA. Electronic address:
Background: Maternal mental health can impact health care access and utilization for both the birthing parent and infant. We examined the association between prenatal depressive symptoms (episodic and chronic) and receipt of the postpartum 6-week visit and infant vaccinations in the first year postpartum.
Methods: Postpartum individuals (N = 672) who attended Expect With Me group prenatal care in Nashville, Tennessee and Detroit, Michigan completed surveys during the second and third trimesters of pregnancy, as well as 6- and 12- months postpartum.
Cross-Sectional Study Gender Pay Gap in Industry General Payments to U.S. General and Fellowship-Trained Surgeons.
J Surg Res
January 2025
Division of Surgical Oncology, Department of Surgery, University of Nebraska Medical Center, Omaha, Nebraska. Electronic address:
Introduction: Gender disparities exist in nonresearch industry payments to U.S. physicians, but detailed analyses specific to surgeons are limited.
View Article and Find Full Text PDFBackground/aims: Certain sociodemographic groups are routinely underrepresented in clinical trials, limiting generalisability. Here, we describe the extent to which enriched enrolment approaches yielded a diverse trial population enriched for older age in a randomised controlled trial of a blood-based multi-cancer early detection test (NCT05611632).
Methods: Participants aged 50-77 years were recruited from eight Cancer Alliance regions in England.
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