International regulatory guidelines require that a 'qualified statistician' takes responsibility for the statistical aspects of a clinical trial used for drug licensing. No consensus on what constitutes a 'qualified statistician' appears to have been developed so far. The International Society for Clinical Biostatistics is issuing this reflection paper in order to stimulate a discussion on the concept.

Download full-text PDF

Source
http://dx.doi.org/10.1002/sim.4345DOI Listing

Publication Analysis

Top Keywords

'qualified statistician'
12
constitutes 'qualified
8
regulatory guidelines
8
considerations constitutes
4
statistician' regulatory
4
guidelines international
4
international regulatory
4
guidelines require
4
require 'qualified
4
statistician' takes
4

Similar Publications

Introduction: Regional anesthesia is frequently used for upper limb surgeries and postoperative pain control. Different approaches to brachial plexus blocks are similarly effective but may differ in the frequency and severity of iatrogenesis. We, therefore, examined large-scale registry data to explore the risks of typical complications among different brachial plexus block sites for regional anesthesia.

View Article and Find Full Text PDF
Article Synopsis
  • The study analyzes self-rated health (SRH) among exclusive e-cigarette users and traditional cigarette smokers, using data from the Health Survey for England 2019, focusing on a refined sample of 274 e-cigarette users and 1,017 cigarette smokers.
  • Results show that exclusive e-cigarette users are more likely to report good health compared to traditional cigarette smokers, with an odds ratio of 1.59, indicating a significant health perception difference.
  • Additional analysis with a broader range of health categories confirmed e-cigarette users consistently reported better health outcomes, reinforcing the notion that they perceive their health more positively than smokers.
View Article and Find Full Text PDF

Perceptions of radiographers on reporting chest images at Public Hospitals in Malawi.

J Med Imaging Radiat Sci

January 2025

Department of Medical Imaging and Radiation Sciences, Faculty of Health Sciences, University of Johannesburg, South Africa.

Introduction: Malawi health facilities' major challenge is inequalities in access to reporting services due to a shortage of radiologists to report on radiographic images. Radiographers in the developed world acquire formal training in image reporting, however, there is no postgraduate training programme in Malawi. Thus, there is a need to explore radiographers' perceptions of reporting chest images in Malawi's hospitals.

View Article and Find Full Text PDF
Article Synopsis
  • * All surgical methods significantly reduced intraocular pressure (IOP), with trabeculectomy showing the highest vision improvement and complete success rates, but also a higher complication rate compared to the other methods.
  • * The findings highlight that while all three procedures effectively manage IOP, trabeculectomy may be preferred for better visual outcomes, though it comes with increased risks, indicating the need for tailored treatment plans.
View Article and Find Full Text PDF

Assessing Institutional Culture for Inclusive Excellence in the Academic Health Sciences.

J Gen Intern Med

November 2024

National Initiative on Gender, Culture and Leadership in Medicine: C-Change, The Heller School for Social Policy and Management, Institute for Economic and Racial Equity, Brandeis University, Waltham, MA, USA.

View Article and Find Full Text PDF

Want 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!