Impact of investigator initiated trials and industry sponsored trials on medical practice (IMPACT): rationale and study design

BMC Medical Research Methodology

S. Lohner¹  K. Wollmann²  E. Nury²  K. Bischoff²  K. Nitschke²  A. Blümle³  M. Schumacher⁴  G. Rücker⁴ 

[1] Cochrane Hungary, Clinical Centre of the University of Pécs, Medical School, University of Pécs, Rákóczi út 2, 7623, Pécs, Hungary;Institute for Evidence in Medicine (for Cochrane Germany Foundation), Faculty of Medicine and Medical Center, University of Freiburg, Breisacher Str. 86, 79110, Freiburg, Germany;Institute for Evidence in Medicine (for Cochrane Germany Foundation), Faculty of Medicine and Medical Center, University of Freiburg, Breisacher Str. 86, 79110, Freiburg, Germany;Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Elsässer Straße 2, 79110, Freiburg, Germany;Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Stefan-Meier-Straße 26, 79104, Freiburg, Germany;

关键词: Randomized controlled trial;    Study registry;    Access to information;    Evidence-based medicine;    Systematic reviews;    Clinical guidelines;    Knowledge translation;    Clinical decision making;    Investigator initiated trials;    Industry sponsored trials;   

DOI  :  10.1186/s12874-020-01125-5

来源: Springer

【 摘 要 】

BackgroundThe German Research Foundation (DFG) and the Federal Ministry of Education and Research (BMBF) initiated large research programs to foster high quality clinical research in the academic area. These investigator initiated trials (IITs) cover important areas of medical research and often go beyond the scope of industry sponsored trials (ISTs). The purpose of this project was to understand to what extent results of randomized controlled IITs and ISTs have an impact on medical practice, measured by their availability for decisions in healthcare and their implementation in clinical practice. We aimed to determine study characteristics influencing a trial’s impact such as type of sponsor and place of conduct. In this article, we describe the rationale and design of this project and present the characteristics of the trials included in our study cohort.MethodsThe research impact of the following sub-cohorts was compared: German IITs (funded by DFG and BMBF or by other German non-commercial organizations), international IITs (without German contribution), German ISTs, and international ISTs. Trials included were drawn from the DFG−/BMBF-Websites, the German Clinical Trials Register, and from ClinicalTrials.gov. Research impact was measured as follows: 1) proportion of published trials, 2) time to publication, 3) proportion of publications appropriately indexed in biomedical databases, 4) proportion of openly accessible publications, 5) broadness of publication’s target group, 6) citation of publications by systematic reviews or meta-analyses, and 7) appearance of publications or citing systematic reviews or meta-analyses in clinical practice guidelines. We also aimed to identify study characteristics associated with the impact of trials.ResultsWe included 691 trials: 120 German IITs, 200 International IITs, 171 German ISTs and 200 International ISTs. The median number of participants was 150, 30% were international trials and 70% national trials, 48% drug-trials and 52% non-drug trials. Overall, 72% of the trials had one pre-defined primary endpoint, 28% two or more (max. 36).ConclusionsThe results of this project deepen our understanding of the impact of biomedical research on clinical practice and healthcare policy, add important insights for the efficient allocation of scarce research resources and may facilitate providing accountability to the different stakeholders involved.

【 授权许可】

CC BY