Daniel Strech
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View article: Towards monitoring of global health research: an exploratory analysis of transparency and stakeholder engagement
Towards monitoring of global health research: an exploratory analysis of transparency and stakeholder engagement Open
Objectives Monitoring systems exist for clinical research transparency in high-income countries, but systematic assessment of these practices in global health (GH) research (GHR) is limited. We evaluated methods for monitoring GHR transpar…
View article: Exploring scalable assessment methods for terminated trials in ClinicalTrials.gov: A cohort analysis of German and Californian trials
Exploring scalable assessment methods for terminated trials in ClinicalTrials.gov: A cohort analysis of German and Californian trials Open
Introduction Clinical trials can terminate early for many reasons, including non-scientific reasons. We aimed to develop scalable semi-automated methods to characterize terminated trials and explore a methodology to estimate the risk of ex…
View article: Operationalising ethics in secondary health-data use: an operator-focused framework for normative governance with audit and performance metrics
Operationalising ethics in secondary health-data use: an operator-focused framework for normative governance with audit and performance metrics Open
BackgroundOperators of health data hubs play a central role in enabling ethical secondary use by implementing consent mechanisms, privacy safeguards, data access procedures, stakeholder engagement and other practices. Despite their normati…
View article: Registration and Reporting of Clinical Trials Affiliated with California Universities and with Primary Completion Date from 2014 to 2017
Registration and Reporting of Clinical Trials Affiliated with California Universities and with Primary Completion Date from 2014 to 2017 Open
Background Public information on US clinical trials is shared through the ClinicalTrials.gov registry. This study’s goal was to determine prospective registration, results reporting, trial registration number reporting, and publication acc…
View article: Accounting for cross-registration in monitoring responsible research in clinical trials: A cross-sectional study of trials at German university medical centers
Accounting for cross-registration in monitoring responsible research in clinical trials: A cross-sectional study of trials at German university medical centers Open
Background Identifying and monitoring clinical trials is crucial for responsible research systems and is relevant to all stakeholders in clinical research. Trial registries support accountability and transparency by providing a publicly av…
View article: Benefits and risks of health data reuse for healthcare providers: stakeholder perspectives from a qualitative interview study
Benefits and risks of health data reuse for healthcare providers: stakeholder perspectives from a qualitative interview study Open
Background Reusing health data, for example for research into the quality of care or healthcare planning, has far-reaching potential. Current ethical discussions on developing health data platforms (e.g. the German Medical Informatics Init…
View article: Resources to aid ethical review of clinical studies: an exploratory scoping review identifying gaps and opportunities
Resources to aid ethical review of clinical studies: an exploratory scoping review identifying gaps and opportunities Open
Background Research Ethics Committees (RECs) review the ethical, legal, and methodological standards of clinical research. Complying with all requirements and professional expectations while maintaining the necessary scientific and ethical…
View article: Transparency in the secondary use of health data: assessing the status quo of guidance and best practices
Transparency in the secondary use of health data: assessing the status quo of guidance and best practices Open
We evaluated what guidance exists in the literature to improve the transparency of studies that make secondary use of health data. To find peer-reviewed papers, we searched PubMed and Google Scholar. To find institutional documents, we use…
View article: Towards Monitoring of Global Health Research: An Exploratory Analysis of Transparency and Stakeholder Engagement
Towards Monitoring of Global Health Research: An Exploratory Analysis of Transparency and Stakeholder Engagement Open
Introduction Global health research (GHR) requires transparent practices and stakeholder engagement to maximize impact. While monitoring systems exist for clinical research transparency in high-income countries, there is limited systematic…
View article: Ethics practices associated with reusing health data: an assessment of patient registries
Ethics practices associated with reusing health data: an assessment of patient registries Open
Background As routinely collected patient data have become increasingly accessible over the years, more attention has been directed at the ethics of using such data for research. Patient data is often available to researchers through patie…
View article: Transparency in the secondary use of health data: Assessing the status quo of guidance and best practices
Transparency in the secondary use of health data: Assessing the status quo of guidance and best practices Open
We evaluated what guidance exists in the literature to improve the transparency of studies that make secondary use of health data. To find relevant literature, we searched PubMed and Google Scholar and drafted a list of health organization…
View article: Navigating the healthcare provider’s data dilemma: stakeholder perspectives on provider risks and benefits of health data reuse. A qualitative interview study
Navigating the healthcare provider’s data dilemma: stakeholder perspectives on provider risks and benefits of health data reuse. A qualitative interview study Open
Background: Reusing health data has far-reaching potential for improving health and healthcare. Current ethical discussions on developing health data platforms (e.g. the German Medical Informatics Initiative, MII) have primarily addressed …
View article: Informing pandemic management in Germany with trustworthy living evidence syntheses and guideline development: lessons learned from the COVID-19 evidence ecosystem
Informing pandemic management in Germany with trustworthy living evidence syntheses and guideline development: lessons learned from the COVID-19 evidence ecosystem Open
CEOsys provided a proof-of-concept for a functioning evidence ecosystem at the national level. Lessons learned include that similar networks should, among others, involve methodological and clinical key stakeholders early on, aim for (inte…
View article: Informed consent and trial prioritization for clinical studies during the COVID-19 pandemic. Stakeholder experiences and viewpoints
Informed consent and trial prioritization for clinical studies during the COVID-19 pandemic. Stakeholder experiences and viewpoints Open
Background Very little is known about the practice-oriented challenges and potential response strategies for effective and efficient translation of informed consent and study prioritization in times of a pandemic. This stakeholder intervie…
View article: Ethics practices associated with reusing health data: An assessment of patient registries
Ethics practices associated with reusing health data: An assessment of patient registries Open
Background As routinely collected patient data have become increasingly accessible over the years, more and more attention has been directed at the ethics of using such data for research purposes. Patient data is often available to researc…
View article: Improving research transparency with individualized report cards: A feasibility study in clinical trials at a large university medical center
Improving research transparency with individualized report cards: A feasibility study in clinical trials at a large university medical center Open
Research transparency is crucial for ensuring the relevance, integrity, and reliability of scientific findings. However, previous work indicates room for improvement across transparency practices. The primary objective of this study was to…
View article: Results reporting for clinical trials led by medical universities and university hospitals in the Nordic countries was often missing or delayed
Results reporting for clinical trials led by medical universities and university hospitals in the Nordic countries was often missing or delayed Open
Objective To systematically evaluate timely reporting of clinical trial results at medical universities and university hospitals in the Nordic countries. Study Design and Setting In this cross-sectional study, we included trials (regardles…
View article: Resources to Aid Ethical Review of Clinical Studies: An Exploratory Scoping Review Identifying Gaps and Opportunities
Resources to Aid Ethical Review of Clinical Studies: An Exploratory Scoping Review Identifying Gaps and Opportunities Open
Background Research Ethics Committees (RECs) review the ethical, legal, and methodological standard of clinical research. However, complying with all requirements and professional expectations while maintaining the necessary scientific and…
View article: Frequency of multiple changes to prespecified primary outcomes of clinical trials completed between 2009 and 2017 in German university medical centers: A meta-research study
Frequency of multiple changes to prespecified primary outcomes of clinical trials completed between 2009 and 2017 in German university medical centers: A meta-research study Open
Background Clinical trial registries allow assessment of deviations of published trials from their protocol, which may indicate a considerable risk of bias. However, since entries in many registries can be updated at any time, deviations m…
View article: Final Dataset for the DIssemination of REgistered COVID-19 Clinical Trials (DIRECCT) Study
Final Dataset for the DIssemination of REgistered COVID-19 Clinical Trials (DIRECCT) Study Open
The DIRECCT study is a multi-phase examination of clinical trial results dissemination during the COVID-19 pandemic. Interim data for trials completed during the first six months of the pandemic (i.e., 1 January 2020 – 30 June 2020) was pr…
View article: Final Dataset for the DIssemination of REgistered COVID-19 Clinical Trials (DIRECCT) Study
Final Dataset for the DIssemination of REgistered COVID-19 Clinical Trials (DIRECCT) Study Open
The DIRECCT study is a multi-phase examination of clinical trial results dissemination during the COVID-19 pandemic. Interim data for trials completed during the first six months of the pandemic (i.e., 1 January 2020 – 30 June 2020) was pr…
View article: Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials
Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials Open
Objective Prospective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported …
View article: Institutional dashboards on clinical trial transparency for University Medical Centers: A case study
Institutional dashboards on clinical trial transparency for University Medical Centers: A case study Open
Background University Medical Centers (UMCs) must do their part for clinical trial transparency by fostering practices such as prospective registration, timely results reporting, and open access. However, research institutions are often un…
View article: Hidden changes to prespecified primary outcomes of clinical trials completed between 2009 and 2017 in German University Medical Centres: A meta-research study
Hidden changes to prespecified primary outcomes of clinical trials completed between 2009 and 2017 in German University Medical Centres: A meta-research study Open
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 registrat…
View article: Should the governance of individual treatment attempts (“Individuelle Heilversuche”) include praxis evaluation? Results from qualitative stakeholder interviews.
Should the governance of individual treatment attempts (“Individuelle Heilversuche”) include praxis evaluation? Results from qualitative stakeholder interviews. Open
The current situation with a complete lack of evaluation insufficiently reflects safety concerns. German health policy decision makers should be more explicit about where and why evaluation is needed. Prospective and retrospective evaluati…
View article: Community consensus on core open science practices to monitor in biomedicine
Community consensus on core open science practices to monitor in biomedicine Open
The state of open science needs to be monitored to track changes over time and identify areas to create interventions to drive improvements. In order to monitor open science practices, they first need to be well defined and operationalized…