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Articles by Daniel Strech
Transparency in the secondary use of health data: Assessing the status quo of guidance and best practices
The authors have declared no competing interest. This study is part of the project HiGHmed, which is funded by the Medical Informatics Initiative of the German Federal Ministry of Education and Research. I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Ethics practices associated with reusing health data: An assessment of patient registries
The authors have declared no competing interest. We have received funding from the European Union's Horizon Europe Research and Innovation Actions under grant no. 101095479 (More-EUROPA). Views and opinions expressed are however those of the authors only and do not necessarily reflect those of the European Union nor the granting authority. Neither the European Union nor the granting authority can be held responsible for them.
Improving research transparency with individualized report cards: A feasibility study in clinical trials at a large university medical center
Introduction The inability to reproduce scientific findings (Baker, 2016; Begley and Ellis, 2012; National Academies of Sciences, Engineering, and Medicine, 2019; Open Science Collaboration, 2015) and the non-or incomplete reporting of research results (Bassler et al., 2016; Franco et al., 2014; Ioannidis et al., 2014; Song et al., 2010; Toews et al., 2017) have raised concerns about research waste, and highlighted the need to promote responsible research practices as a means to increase...
Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials
Methods Data sources and sample We based our sample on two related projects that were conducted at our research group.19 20 The projects have drawn a full sample (n=3113) of registry entries for interventional studies reported as complete between 2009 and 2017, led by a German UMC and registered in one of two registries: DRKS, which is the WHO primary trial registry for Germany, and ClinicalTrials.gov, which is also routinely used in Germany to register clinical research and accepted by the...
Hidden changes to prespecified primary outcomes of clinical trials completed between 2009 and 2017 in German University Medical Centres: A meta-research study
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 registry entry, but would require analysing the registration history. Design: Meta-research study.
Reporting of Retrospective Registration in Clinical Trial Publications
Abstract Objective: Prospective registration of clinical research has been widely implemented and advocated for many reasons: to detect and mitigate publication bias, selective reporting, and undisclosed changes in the determination of primary and secondary outcomes. Prospective registration allows for public scrutiny of trials, facilitates the identification of gaps in research, and supports the coordination of efforts by preventing unnecessary duplication.
CONTRAST – CalifOrNia TRiAlS Transparency
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Results availability and timeliness of registered COVID-19 clinical trials: interim cross-sectional results from the DIRECCT study
Medical publishing and peer review Results availability and timeliness of registered COVID-19 clinical trials: interim cross-sectional results from the DIRECCT study http://orcid.org/0000-0003-1934-9504Maia Salholz-Hillel1, http://orcid.org/0000-0001-5658-2482Peter Grabitz1, Molly Pugh-Jones1, Daniel Strech1, http://orcid.org/0000-0001-8286-1995Nicholas J DeVito2 1QUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitatsmedizin Berlin, Berlin, Germany...
Results publications are inadequately linked to trial registrations: An automated pipeline and evaluation of German university medical centers
Abstract Objective To evaluate links between registration and publication across clinical trials led by German university medical centers (UMCs) and registered in either ClinicalTrials.gov or the German Clinical Trials Registry (DRKS). Inadequate links make trial publications and registrations less findable and compromise evidence synthesis and health policy decision making. The World Health Organization (WHO) and others call for better adoption of this straightforward transparency practice.
Results Availability and Timeliness of Registered COVID-19 Clinical Trials: A Cross-Sectional Study
ABSTRACT Objective To examine how and when the results of COVID-19 clinical trials are disseminated.
Details of risk–benefit communication in informed consent documents for phase I/II trials - Hannes Kahrass, Sabine Bossert, Christopher Schürmann, Daniel Strech, 2020
1. WMA . World medical association declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013; 310: 2191–2194. Google Scholar | Crossref | Medline | ISI 2. Council for International Organizations of Medical Services . International ethical guidelines for health-related research involving human subjects. Geneva: CIOMS, 2016. Google Scholar 3. European Union .
Investigator brochures for phase I/II trials lack information on the robustness of preclinical safety studies
ORIGINAL ARTICLE Soeren Sievers Corresponding Author E-mail address: sievers.soeren@mh‐hannover.de https://orcid.org/0000-0002-6462-1223 Hannover Medical School, Institute for Ethics, History, and Philosophy of Medicine, 30625 Hannover, Germany Correspondence Soeren Sievers, Hannover Medical School, Institute for Ethics, History, and Philosophy of Medicine, Carl‐Neuberg Str. 1, 30625 Hannover, Germany.
Reporting of prior clinical studies in Investigator’s Brochures did not adhere to the basic principles of evidence synthesis: A cross-sectional study
This paper is only available as a PDF. To read, Please Download here. Abstract Objective International regulations require Investigator’s Brochures (IBs) to compile all available evidence that inform the risk-benefit assessment for the newly planned clinic trial. This study examined the adherence of IBs to the basic principles of evidence synthesis when compiling prior clinical studies.
Improving the trustworthiness, usefulness, and ethics of biomedical research through an innovative and comprehensive institutional initiative
Loading metrics Open Access Community Page Community Page The Community Page is a forum for organizations and societies to highlight their efforts to enhance the dissemination and value of scientific knowledge.
3Rs missing: animal research without scientific value is unethical
3Rs missing: animal research without scientific value is unethical Daniel Strech1,2, Ulrich Dirnagl1,2,3 1 QUEST Center for Transforming Biomedical Research, Berlin Institute of Health (BIH), Berlin, Germany 2 Charité - Universitätsmedizin Berlin, Berlin, Germany 3 NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin, Berlin, Germany Correspondence to Daniel Strech; daniel.strech{at}charite.de Abstract The current, widely established 3R framework for the ethical use of...
Routinely collected data for randomized trials: promises, barriers, and implications
Routinely collected health data (RCD), such as electronic health records (EHRs), registries, or administrative claims data, are useful for randomized controlled trials (RCTs), especially those whose aim is pragmatic. RCTs embedded in routine data collection might be the next disruptive clinical research technology [1]. However, numerous fundamental questions have recently been raised [1–8].
The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review
When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care.
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