The Food and Drug Administration (FDA) has recommended that clinical trial study populations accurately reflect the patients likely to use the product, if approved. The FDA has not provided specific guidance on how cohort sizes of clinically relevant demographic characteristics should be determined. Therefore, the present study was designed to compare demographic characteristics reported in US-only FDA approval trials to the demographic characteristics of the related medical disorders in an electronic health records database of >150 M patients in the United States (US). The results demonstrate that comparative disparities in demographic cohort proportions are common, yet inconsistent, and highlight the need to define disorder specific demographic cohort proportion goals in future clinical trials.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11043810 | PMC |
| http://dx.doi.org/10.1016/j.conctc.2024.101293 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Characterization of trends in preoperative hemoglobin A1c testing prior to metabolic and bariatric surgery: a retrospective, observational study.
Perioper Med (Lond)
January 2025
Department of Surgery, Yale School of Medicine, New Haven, CT, 06510, USA.
Background: Irrespective of baseline diabetes status, preoperative hemoglobin A1c (A1C) influences perioperative care in patients undergoing metabolic and bariatric surgery (MBS). Accordingly, the American Society of Metabolic and Bariatric Surgery (ASMBS) endorses that patients undergoing MBS should receive a preoperative A1C test. We aimed to assess the proportion of MBS patients who received a preoperative A1C test and determine whether baseline diabetes status influences receipt of a test.
View Article and Find Full Text PDFCharacteristics of e-scooter and bicycle injuries at a university hospital in a large German city - a one-year analysis.
Inj Epidemiol
January 2025
Department of Trauma Surgery, TUM University Hospital Klinikum Rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.
Background: The increasing adoption of individual urban mobility in European cities is contributing to a rise in the number of bicycle and e-scooter users. Consequently, a corresponding increase in accidents, along with an additional burden on emergency departments, is anticipated, particularly in metropolitan areas. The objective of this prospective cross-sectional study was to gather detailed information regarding the patient demographics, accident mechanisms, and injury patterns of e-scooter riders in comparison to cyclists.
View Article and Find Full Text PDFAssessment of public literacy in TB prevention and control in the National 13th Five-Year plan for Tuberculosis Prevention and Control (2016-2020) in China.
BMC Health Serv Res
January 2025
School of Public Health, Lanzhou University, Lanzhou, Gansu, China.
Background: China has always been a country with a high burden of tuberculosis. In order to end TB, the Chinese government launched three plans for TB prevention and control. The Chinese government implemented the National 13th Five-Year plan for Tuberculosis Prevention and Control (2016-2020) to promote TB prevention and control from policy, technology, health promotion and other aspects from 2016 to 2020.
View Article and Find Full Text PDFPhysical functioning trajectories over statutory retirement: a finnish occupational cohort study.
Arch Public Health
January 2025
Department of Public Health, University of Helsinki, Helsinki, Finland.
Background: The association of workload and performance with physical functioning is recognised among the ageing public sector workforce. The characteristics of working conditions and social- and health-related factors associated with physical functioning after statutory retirement are still unknown. Also, previous studies on changes in physical functioning have not used a person-oriented approach.
View Article and Find Full Text PDFEffects of COVID-19 on short-term outcomes of hip arthroplasty: a multicenter, retrospective, propensity score matched study.
BMC Musculoskelet Disord
January 2025
Department of Orthopedic Surgery, Chang Gung Memorial Hospital, Linkou, Taiwan.
Purpose: The Coronavirus Disease 2019 (COVID-19) pandemic delayed elective procedures such as total joint arthroplasty. As surgical volumes return to prepandemic levels, understanding the implications of COVID-19 becomes imperative. This study explored the effects of COVID-19 on the short-term outcomes of hip arthroplasty.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!