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\"This book aims to highlight the gaps and the transparency issues in the clinical research and trials processes and how there is a lack of information flowing back to researchers and patients involved in those trials. Lack of data transparency is an underlying theme within the clinical research world and causes issues of corruption, fraud, errors and a problem of reproducibility. Blockchain can prove to be a method to ensure a much more joined up and integrated approach to data sharing and improving patient outcomes. Surveys undertaken by creditable organisations in the healthcare industry are analysed in this book that show strong support for using blockchain technology regarding strengthening data security, interoperability and a range of beneficial use cases where mostly all respondents of the surveys believe blockchain will be important for the future of the healthcare industry. Another aspect considered in the book is the coming surge of healthcare wearables using Internet of Things (IoT) and the prediction that the current capacity of centralised networks will not cope with the demands of data storage. The benefits are great for clinical research, but will add more pressure to the transparency of clinical trials and how this is managed unless a secure mechanism like, blockchain is used\"--Publisher's description.

Biomedical data warehouses (BDWs) have become an essential tool to facilitate the reuse of health data for both research and decisional applications. Beyond technical issues, the implementation of BDWs requires strong institutional data governance and operational knowledge of the European and national legal framework for the management of research data access and use. In this paper, we describe the compound process of implementation and the contents of a regional university hospital BDW. We present the actions and challenges regarding organizational changes, technical architecture, and shared governance that took place to develop the Nantes BDW. We describe the process to access clinical contents, give details about patient data protection, and use examples to illustrate merging clinical insights. More than 68 million textual documents and 543 million pieces of coded information concerning approximately 1.5 million patients admitted to CHUN between 2002 and 2022 can be queried and transformed to be made available to investigators. Since its creation in 2018, 269 projects have benefited from the Nantes BDW. Access to data is organized according to data use and regulatory requirements. Data use is entirely determined by the scientific question posed. It is the vector of legitimacy of data access for secondary use. Enabling access to a BDW is a game changer for research and all operational situations in need of data. Finally, data governance must prevail over technical issues in institution data strategy vis-à-vis care professionals and patients alike.

\"Data mining has rapidly emerged as an enabling, robust, and scalable technique to analyze data for novel patterns, trends, anomalies, structures, and features that can be employed for a variety of biomedical and clinical domains. Approaching the techniques and challenges of image mining from a multidisciplinary perspective, this book presents data mining techniques, methodologies, algorithms, and strategies to analyze biomedical signals and images. Written by experts, the text addresses data mining paradigms for the development of biomedical systems. It also includes special coverage of knowledge discovery in mammograms and emphasizes both the diagnostic and therapeutic fields of eye imaging\"--Provided by publisher.

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial. In the present scenario, there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of product. With the implementation of regulatory compliant data management tools, CDM team can meet these demands. Additionally, it is becoming mandatory for companies to submit the data electronically. CDM professionals should meet appropriate expectations and set standards for data quality and also have a drive to adapt to the rapidly changing technology. This article highlights the processes involved and provides the reader an overview of the tools and standards adopted as well as the roles and responsibilities in CDM.

The 2019 coronavirus disease (COVID-19) pandemic increased efforts for rapid data sharing and dissemination among researchers as well as to data repositories. Researchers and studies prioritized data sharing, which increased understanding of SARS-CoV-2's pathology. Eventually, this effort to maximize collaboration and data dissemination, led to the development of mRNA vaccines. This successful effort has highlighted the importance of data sharing and the implementation of data management policies, including the National Institutes of Health's (NIH) Data Sharing Policy of 2023. Moreover, programs such as the National Institute of Allergy and Infectious Diseases (NIAID) funded Collaborative Influenza Vaccine Innovation Centers (CIVICs), have beta-tested this policy, with the help of the Statistical, Data Management and Coordination Center (SDMCC) and its data standards, and deemed it useful. However, the process has also initiated pertinent discussion on potential improvements and optimizations for the future of data sharing. Here, I use the CIVICs data sharing reporting standards and process as a data sharing example, and suggest logistical improvements to propose a better-equipped model for the vaccinology community.

To reduce the mortality related to bladder cancer, efforts need to be concentrated on early detection of the disease for more effective therapeutic intervention. Strong risk factors (eg, smoking status, age, professional exposure) have been identified, and some diagnostic tools (eg, by way of cystoscopy) have been proposed. However, to date, no fully satisfactory (noninvasive, inexpensive, high-performance) solution for widespread deployment has been proposed. Some new models based on cytology image classification were recently developed and bring good perspectives, but there are still avenues to explore to improve their performance. Our team aimed to evaluate the benefit of combining the reuse of massive clinical data to build a risk factor model and a digital cytology image-based model (VisioCyt) for bladder cancer detection. The first step relied on designing a predictive model based on clinical data (ie, risk factors identified in the literature) extracted from the clinical data warehouse of the Rennes Hospital and machine learning algorithms (logistic regression, random forest, and support vector machine). It provides a score corresponding to the risk of developing bladder cancer based on the patient's clinical profile. Second, we investigated 3 strategies (logistic regression, decision tree, and a custom strategy based on score interpretation) to combine the model's score with the score from an image-based model to produce a robust bladder cancer scoring system. We collected 2 data sets. The first set, including clinical data for 5422 patients extracted from the clinical data warehouse, was used to design the risk factor-based model. The second set was used to measure the models' performances and was composed of data for 620 patients from a clinical trial for which cytology images and clinicobiological features were collected. With this second data set, the combination of both models obtained areas under the curve of 0.82 on the training set and 0.83 on the test set, demonstrating the value of combining risk factor-based and image-based models. This combination offers a higher associated risk of cancer than VisioCyt alone for all classes, especially for low-grade bladder cancer. These results demonstrate the value of combining clinical and biological information, especially to improve detection of low-grade bladder cancer. Some improvements will need to be made to the automatic extraction of clinical features to make the risk factor-based model more robust. However, as of now, the results support the assumption that this type of approach will be of benefit to patients.

PurposeIn order to meet restrictions and difficulties in the development of hospital medical informatization and clinical databases in China, in this study, a disease-specific clinical database system (DSCDS) was designed and built. It provides support for the full utilization of real world medical big data in clinical research and medical services for specific diseases.MethodsThe development of DSCDS involved (1) requirements analysis on precision medicine, medical big data, and clinical research; (2) design schematics and basic architecture; (3) standard datasets of specific diseases consisting of common data elements (CDEs); (4) collection and aggregation of specific disease data scattered in various medical business systems of the hospital; (5) governance and quality improvement of specific disease data; (6) data storage and computing; and (7) design of data application modules.ResultsA DSCDS for liver cirrhosis was created in the gastrointestinal department of a 3A grade hospital in China and had more than nine data application modules. Based on this DSCDS, a series of clinical studies are being carried out, such as retrospective or prospective cohorts, prognostic studies using multimodal data, and follow-up studies.ConclusionThe development of the DSCDS for liver cirrhosis in this paper provides experience and reference for the design and development of DSCDSs for other specific diseases in China; it can even expand to the development of DSCDSs in other countries if they have the demand for DSCDS and the same or better medical informatization foundation. DSCDS has more accurate, standard, comprehensive, multimodal and usable data of specific diseases than the general clinical database system and clinical data repository (CDR) and provides a credible data foundation for medical research, clinical decision-making and improving the medical service quality of specific diseases.

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

In recent years, many researchers have focused on the use of legacy data, such as pooled analyses that collect and reanalyze data from multiple studies. However, the methodology for the integration of preexisting databases whose data were collected for different purposes has not been established. Previously, we developed a tool to efficiently generate Study Data Tabulation Model (SDTM) data from hypothetical clinical trial data using the Clinical Data Interchange Standards Consortium (CDISC) SDTM. This study aimed to design a practical model for integrating preexisting databases using the CDISC SDTM. Data integration was performed in three phases: (1) the confirmation of the variables, (2) SDTM mapping, and (3) the generation of the SDTM data. In phase 1, the definitions of the variables in detail were confirmed, and the data sets were converted to a vertical structure. In phase 2, the items derived from the SDTM format were set as mapping items. Three types of metadata (domain name, variable name, and test code), based on the CDISC SDTM, were embedded in the Research Electronic Data Capture (REDCap) field annotation. In phase 3, the data dictionary, including the SDTM metadata, was outputted in the Operational Data Model (ODM) format. Finally, the mapped SDTM data were generated using REDCap2SDTM version 2. SDTM data were generated as a comma-separated values file for each of the 7 domains defined in the metadata. A total of 17 items were commonly mapped to 3 databases. Because the SDTM data were set in each database correctly, we were able to integrate 3 independently preexisting databases into 1 database in the CDISC SDTM format. Our project suggests that the CDISC SDTM is useful for integrating multiple preexisting databases.