Preparing clinicians to be site investigators in multicenter clinical trials: A training program at an academic medical center

Clinical trials are essential in the translation of biomedical discoveries to new clinical interventions and therapeutics. Successful multisite clinical trials require qualified site investigators with an understanding of the full spectrum of processes and requirements from trial identification through closeout. New site investigators may be deterred by competing demands on their time, the complexity of administrative and regulatory processes for trial initiation and conduct, and limited access to experienced mentor networks. We established a Clinical Trialist Training Program (CTTP) and complimentary Clinical Trials Bootcamp at our institution to address these barriers and increase the number of local site investigators enabled to lead successful clinical trials. An initial cohort of four CTTP scholars received salary support with protected time, didactic training, assistance with study identification and start-up navigation, and quarterly progress meetings. By the end of the 12-month program, this initial cohort identified 33 new trials, utilized feasibility assessments, and reported being on target to sustain their protected time from new clinical trials. Bootcamp attendees demonstrated increased knowledge of resources, offices, and processes associated with clinical trial conduct. Our results support providing compensated protected time, training, and access to experienced clinical research professionals to enable clinicians to become successful site investigators

A registry-based follow-up study, comparing the incidence of cardiovascular disease in native Danes and immigrants born in Turkey, Pakistan and the former Yugoslavia: do social inequalities play a role?

<p>Abstract</p> <p>Background</p> <p>This study compared the incidence of cardiovascular disease (CVD) and acute myocardial infarction (AMI) between native Danes and immigrants born in Turkey, Pakistan and the former Yugoslavia. Furthermore, we examined whether different indicators of socioeconomic status (SES), such as employment, income and housing conditions influenced potential differences.</p> <p>Methods</p> <p>In this registry-based follow-up study individuals were identified in a large database that included individuals from two major regions in Denmark, corresponding to about 60% of the Danish population. Incident cases of CVD and AMI included fatal and non-fatal events and were taken from registries. Using Cox regression models, we estimated incidence rates at 5-year follow-up.</p> <p>Results</p> <p>Immigrant men and women from Turkey and Pakistan had an increased incidence of CVD, compared with native Danish men. In the case of AMI, a similar pattern was observed; however, differences were more pronounced. Pakistanis and Turks with a shorter duration of residence had a lower incidence, compared with those of a longer residence. Generally, no notable differences were observed between former Yugoslavians and native Danes. In men, differences in CVD and AMI were reduced after adjustment for SES, in particular, among Turks regarding CVD. In women, effects were particularly reduced among Yugoslavians in the case of CVD and in Turks in the case of CVD and AMI after adjustment for SES.</p> <p>Conclusions</p> <p>In conclusion, country of birth-related differences in the incidence of CVD and AMI were observed. At least some of the differences that we uncovered were results of a socioeconomic effect. Duration of residence also played a certain role. Future studies should collect and test different indicators of SES in studies of CVD among immigrants.</p

VivoPoster2016v4_JO.pdf

Using data from research studies and clinical trials to enrich researcher profiles.<br

Introduction to citizen science. The case of Fangstjournalen.dk

DTU Library is celebrating Love Data Week 2020 with the mission to raise awareness about the data surrounding us and library-based research data services. In this video Researcher Christian Skov from DTU Aqua tells about the Citizen Science project “Fangstjournalen” and how Citizens engage in collecting data and co-creating knowledge. A knowledge- creation helping us to learn more about the world we live in. This video is produced by four Danish Universities as part of a project financially supported by DEFF. The aim of the project is to identify the role of Danish Research Libraries in the dissemination and support of Citizen Science

9 things to make citizen science data FAIR. A research librarian’s guide.

This guide aims to support research librarians serve citizen science projects with the competencies already embedded in many university libraries; they have long been the hub for knowledge of Open Science, they have a multidisciplinary outreach and organise activities connecting students, faculty and the public. Citizen science has a broad scope, and involve voluntary and active public engagement. Embedding citizen science projects in academia may prove useful for many reasons: expanding and improving current research activities and strengthening the interaction of scientists with the public. Citizen Science belongs to the Open Science domain, and is therefore, perceived as a discipline, where research data are shared openly, with open access to publications and full transparency of data availability. However, in some cases, data use have to be limited to comply with ethical and legal conditions, for example due to privacy concerns. For many scientists, major obstacles to share data openly with citizens are the concern of handling personal data, but also the academic reward system weighing publications over data sharing. The FAIR principles are applicable to data regardless of their public availability. The four elements, Findable, Accessible, Interoperable and Reusable are designed to help lower barriers to access generated research and to facilitate potential new findings by promoting the availability and reuse of data. With this guide, we aim to show how research data management in citizen science can benefit from the FAIR principles. The 9 things of this guide are based on research data management challenges identified for citizen science projects (Holmstrand et al. 2020). Understanding these challenges is an important foundation for guidance provided by the research librarian to any citizen science project manager. The 9 things are structured with the FAIR elements in focus, highlighting practical aspects and benefits of FAIR data in citizen science projects

FAIR data in a Citizen Science project “Fangstjournalen”

In this video Researcher Christian Skov from DTU Aqua tells about the Citizen Science project “Fangstjournalen” and how Research Data Management, data sharing and following the FAIR guiding principles for research data can increase the impact and the value of the research - even beyond the scope of the project. This video is produced by four Danish Universities as part of a project financially supported by DEFF. The aim of the project is to identify the role of Danish Research Libraries in the dissemination and support of Citizen Science

Male breast cancer: a nation-wide population-based comparison with female breast cancer

Objective: Describe prognostic parameters of Danish male breast cancer patients (MBCP) diagnosed from 1980–2009. Determine all-cause mortality compared to the general male population and analyze survival/mortality compared with Danish female breast cancer patients (FBCP) in the same period. Material and methods: The MBCP cohort was defined from three national registers. Data was extracted from medical journals. Data for FBCP is from the DBCG database. Overall survival (OS) was quantified by Kaplan–Meier estimates. Standardized mortality ratios (SMRs) were calculated based on mortality rate among patients relative to the mortality rate in the general population. The association between SMR and risk factors were analyzed in univariate and multivariable Poisson regression models. Separate models for each gender were used for the analyses. Results: We found a marked difference in OS for the two genders. For the total population of MBCP, 5- and 10-year survivals were 55.1% and 31.7%, respectively. For FBCP, the corresponding figures were 76.8% and 59.3%. Median age at diagnosis for FBCP was 61 years and 70 years for MBCP. By applying SMR, the difference in mortality between genders equalized and showed pronounced age-dependency. For male

Additional file 1 of Associations of health literacy with socioeconomic position, health risk behavior, and health status: a large national population-based survey among Danish adults

Additional file 1: Table S1. Demographic and socioeconomic characteristics of Danish residents aged 25 years or older in 2016 and 2017 by interview or web-based distribution. Data are presented as medians with 25th (Q1) and 75th (Q3) percentiles (age) or number of residents and percentage (all others)