clinical research data
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Author(s):  
Mary Banach ◽  
Kaye H Fendt ◽  
Johann Proeve ◽  
Dale Plummer ◽  
Samina Qureshi ◽  
...  

With the focus of the COVID-19 pandemic, we wanted to reach all stakeholders representing communities concerned with good clinical data management practices. We wanted to represent not only data managers but bio-statisticians, clinical monitors, data scientists, informaticians, and all those who collect, organize, analyze, and report on clinical research data. In our paper we will discuss the history of clinical data management in the US and its evolution from the early days of FDA guidance. We will explore the role of biomedical research focusing on the similarities and differences in industry and academia clinical research data management and what we can learn from each other. We will talk about our goals for recruitment and training for the CDM community and what we propose for increasing the knowledge and understanding of good clinical data practice to all – particularly our front-line data collectors i.e., nurses, medical assistants, patients, other data collectors. Finally, we will explore the challenges and opportunities to see CDM as the hub for good clinical data research practices in all of our communities.We will also discuss our survey on how the COVID-19 pandemic has affected the work of CDM in clinical research.


2021 ◽  
Vol 22 (16) ◽  
pp. 8649
Author(s):  
Lenka Koklesova ◽  
Alena Liskova ◽  
Marek Samec ◽  
Kevin Zhai ◽  
Raghad Khalid AL-Ishaq ◽  
...  

Multi-factorial mitochondrial damage exhibits a “vicious circle” that leads to a progression of mitochondrial dysfunction and multi-organ adverse effects. Mitochondrial impairments (mitochondriopathies) are associated with severe pathologies including but not restricted to cancers, cardiovascular diseases, and neurodegeneration. However, the type and level of cascading pathologies are highly individual. Consequently, patient stratification, risk assessment, and mitigating measures are instrumental for cost-effective individualized protection. Therefore, the paradigm shift from reactive to predictive, preventive, and personalized medicine (3PM) is unavoidable in advanced healthcare. Flavonoids demonstrate evident antioxidant and scavenging activity are of great therapeutic utility against mitochondrial damage and cascading pathologies. In the context of 3PM, this review focuses on preclinical and clinical research data evaluating the efficacy of flavonoids as a potent protector against mitochondriopathies and associated pathologies.


2021 ◽  
Vol 11 (1) ◽  
pp. 42-59
Author(s):  
V.  A. Aliev ◽  
Z.  Z. Mamedli ◽  
Yu.  A. Barsukov ◽  
Z.   A. Dudaev ◽  
P.  A. Tikhonov ◽  
...  

This article explores evolution of treatment options in colorectal cancer with synchronous metastatic disease, role of surgical approach on different stages of combined‑modality therapy, including “liver first” strategy. Prospects of perioperative and neoadjuvant polychemotherapy in patients with colorectal cancer with synchronous distant metastases to liver, data on possibility of using radiation therapy in treatment of primary tumor and liver metastases, as well as risks and benefits of this approach and available clinical research data are analyzed.


Author(s):  
Thaer Idrees ◽  
Wesley H Prieto ◽  
Sabina Casula ◽  
Aswathy Ajith ◽  
Matthew Etthelson ◽  
...  

Abstract Background Treatment with levothyroxine (LT4) that normalize serum TSH is expected to restore lipid metabolism. Methods Here we assessed statin utilization in LT4-treated patients through an observational drug utilization study in 3 sites: #1: 10,723 outpatients placed on LT4 during 2006-2019 identified from the Clinical Research Data Warehouse of the University of Chicago; #2: ∼1.4 million LT4 prescriptions prepared by primary care physicians during January-December 2018, identified from the AQVIA™ database of medical prescriptions in Brazil; #3: ~5.4 million patient interviews during 2009-2019, including ~0.32 million patients on LT4, identified from the Fleury Group database in Brazil. Results On Site #1, initiation of therapy with LT4 increased the frequency of statin utilization (19.1 vs 24.6%), which occurred ~1.5 years later (median 76 wks) and, among those patients that were on statins, increased intensity of treatment by 33%, despite normalization of serum TSH levels; on Site #2, after matching for sex and age, the frequency of statins prescription was higher for those patients using LT4: females: 2.1 vs 3.4% (OR: 1.656 [1.639 - 1.673]); males: 3.1 vs 4.4% (OR: 1.435 [1.409 - 1.462]); and, on Site #3, after matching for sex and age, the frequency of statins utilization was higher in those patients using LT4: females: 10 vs 18% (OR: 2.02 [2.00 - 2.04]); males: 15 vs 25% (OR: 1.92 [1.88 - 1.96]); all P-values were <.0001. Conclusion Prescription and utilization of statins were higher in patients taking LT4. The reasons for this association should be addressed in future studies.


2021 ◽  
pp. 532-543
Author(s):  
Matthias Ganzinger ◽  
Enrico Glaab ◽  
Jules Kerssemakers ◽  
Sven Nahnsen ◽  
Ulrich Sax ◽  
...  

2020 ◽  
Vol 108 ◽  
pp. 103491
Author(s):  
Lauren Houston ◽  
Ping Yu ◽  
Allison Martin ◽  
Yasmine Probst

Author(s):  
Giridhar Murali

This poster presentation contains clinical research data that was used in order to enhance IPF (Idiopathic Pulmonary Fibrosis) patient experience, and education about the OFEV drug to treat the rare disease. This data and presentation was published internally in Boehringer Ingelheim.


2020 ◽  
Vol 59 (02/03) ◽  
pp. 075-085
Author(s):  
Samuel Hume ◽  
Surendra Sarnikar ◽  
Cherie Noteboom

Abstract Background The clinical research data lifecycle, from data collection to analysis results, functions in silos that restrict traceability. Traceability is a requirement for regulated clinical research studies and an important attribute of nonregulated studies. Current clinical research software tools provide limited metadata traceability capabilities and are unable to query variables across all phases of the data lifecycle. Objectives To develop a metadata traceability framework that can help query and visualize traceability metadata, identify traceability gaps, and validate metadata traceability to improve data lineage and reproducibility within clinical research studies. Methods This research follows the design science research paradigm where the objective is to create and evaluate an information technology (IT) artifact that explicitly addresses an organizational problem or opportunity. The implementation and evaluation of the IT artifact demonstrate the feasibility of both the design process and the final designed product. Results We present Trace-XML, a metadata traceability framework that extends standard clinical research metadata models and adapts graph traversal algorithms to provide clinical research study traceability queries, validation, and visualization. Trace-XML was evaluated using analytical and qualitative methods. The analytical methods show that Trace-XML accurately and completely assesses metadata traceability within a clinical research study. A qualitative study used thematic analysis of interview data to show that Trace-XML adds utility to a researcher's ability to evaluate metadata traceability within a study. Conclusion Trace-XML benefits include features that (1) identify traceability gaps in clinical study metadata, (2) validate metadata traceability within a clinical study, and (3) query and visualize traceability metadata. The key themes that emerged from the qualitative evaluation affirm that Trace-XML adds utility to the task of creating and assessing end-to-end clinical research study traceability.


2020 ◽  
Vol 33 (4) ◽  
pp. 1016-1025
Author(s):  
Mathias Kaspar ◽  
Leon Liman ◽  
Maximilian Ertl ◽  
Georg Fette ◽  
Lea Katharina Seidlmayer ◽  
...  

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