A5052380826- Health Systems, Economic Evaluations, Quality of Life
- Meta-analysis and systematic reviews
- Ethics in Clinical Research
- Clinical practice guidelines implementation
- Healthcare cost, quality, practices
- Biomedical Ethics and Regulation
- Health and Medical Research Impacts
- Healthcare Policy and Management
- Economic and Financial Impacts of Cancer
- Animal testing and alternatives
- Global Health Care Issues
- Biomedical and Engineering Education
Berlin Institute of Health at Charité - Universitätsmedizin Berlin
2021-2023
Center for Responsible Travel
2023
Objective Prospective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective is still commonly found. We assessed to what extent reported transparently journal publications investigated factors associated with transparent reporting. Design used dataset of trials registered ClinicalTrials.gov or Deutsches Register Klinischer Studien, German University Medical Center the lead centre, completed 2009–2017, corresponding peer-reviewed...
Assess the extent to which clinical trial registration and reporting policies of 25 world's largest public philanthropic medical research funders meet best practice benchmarks as stipulated by 2017 WHO Joint Statement, document changes in monitoring systems 19 European over past year.Cross-sectional study, based on assessments each funder's publicly available documentation plus validation results funders. Our cohort includes Europe, Oceania, South Asia, Canada.Scoring all using an 11-item...
Background Clinical trial registries allow assessment of deviations published trials from their protocol, which may indicate a considerable risk bias. However, since entries in many can be updated at any time, go unnoticed. We aimed to assess the frequency changes primary outcomes different historical versions registry entries, and how often they would unnoticed if only between reports most recent entry are assessed. Methods findings analyzed complete history all 1746 randomized controlled...
Abstract Objectives Assess the extent to which clinical trial registration and reporting policies of 25 world’s largest public philanthropic medical research funders meet best practice benchmarks as stipulated by 2017 WHO Joint Statement,(1) document changes in monitoring systems 19 European over past year. Design, Setting, Participants Cross sectional study, based on assessments each funder’s publicly available documentation plus validation results funders. Our cohort includes Europe,...
Objective: Prospective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective is still commonly found. We assessed to what extent reported transparently journal publications, investigated factors associated with transparent reporting. Design: used dataset of trials registered ClinicalTrials.gov or Deutsches Register Klinischer Studien, German University Medical Center the lead center, completed 2009-2017, corresponding peer-reviewed...
Abstract Objectives To assess how often clinical trials exhibit primary outcome discrepancies within registry records that would not be caught by comparing results publications to the latest entry, but require analysing registration history. Design Meta-research study. Setting All 1746 randomised with published results, registered in ClinicalTrials.gov or Deutsches Register Klinischer Studien (DRKS), completed at German University Medical Centres between 2009 and 2017. We analysed entries...
ABSTRACT Research ethics committees (RECs) and regulatory agencies assess whether the benefits of a proposed early-stage clinical trial outweigh risks based on preclinical studies reported in investigator’s brochures (IBs). Recent have indicated that evidence presented IBs is way does not enable proper risk-benefit assessment. We interviewed different stakeholders (regulators, REC members, industry representatives, researchers, ethicists, metaresearchers) about their views measures to...
Abstract Background: Systematic reviews of health economic evaluations (SR-HEs) provide a critical tool for synthesizing published literature to guide decision makers towards implementing evidence-based policy and healthcare practice. However, the quality methodology reporting SRs is often flawed due insufficiencies in their design, conduct reporting. Meta-research has led methodological improvements many research fields but not widely established evidence synthesis. To enable future...