Impact of investigator initiated trials and industry sponsored trials on medical practice (IMPACT): rationale and study
- PDF / 872,781 Bytes
- 15 Pages / 595.276 x 790.866 pts Page_size
- 19 Downloads / 141 Views
(2020) 20:246
RESEARCH ARTICLE
Open Access
Impact of investigator initiated trials and industry sponsored trials on medical practice (IMPACT): rationale and study design E. Nury1* , K. Bischoff1, K. Wollmann1, K. Nitschke1, S. Lohner2, M. Schumacher3, G. Rücker3 and A. Blümle1,4
Abstract Background: The 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. Methods: The 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. Results: We 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). (Continued on next page)
* Correspondence: [email protected] 1 Institute for Evidence in Medicine (for Cochrane Germany Foundation), Faculty of Medicine and Medical Center, University of Freiburg, Breisacher Str. 86, 79110 Freiburg, Germany Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Co
Data Loading...
