Catalogue Search | MBRL
Are you sure you want to remove the book from the shelf?
{{itemTitle}}
67,563
result(s) for
"data monitoring"
Sort by:
Independent data monitoring committees: Preparing a path for the future
Independent data monitoring committees (IDMCs) were introduced to monitor patient safety and study conduct in randomized clinical trials (RCTs), but certain challenges regarding the utilization of IDMCs have developed. First, the roles and responsibilities of IDMCs are expanding, perhaps due to increasing trial complexity and heterogeneity regarding medical, ethical, legal, regulatory, and financial issues. Second, no standard for IDMC operating procedures exists, and there is uncertainty about who should determine standards and whether standards should vary with trial size and design. Third, considerable variability in communication pathways exist across IDMC interfaces with regulatory agencies, academic coordinating centers, and sponsors. Finally, there has been a substantial increase in the number of RCTs using IDMCs, yet there is no set of qualifications to help guide the training and development of the next generation of IDMC members. Recently, an expert panel of representatives from government, industry, and academia assembled at the Duke Clinical Research Institute to address these challenges and to develop recommendations for the future utilization of IDMCs in RCTs.
Journal Article
The impact of clinical trial monitoring approaches on data integrity and cost—a review of current literature
Purpose
Monitoring is a costly requirement when conducting clinical trials. New regulatory guidance encourages the industry to consider alternative monitoring methods to the traditional 100 % source data verification (SDV) approach. The purpose of this literature review is to provide an overview of publications on different monitoring methods and their impact on subject safety data, data integrity, and monitoring cost.
Methods
The literature search was performed by keyword searches in MEDLINE and hand search of key journals. All publications were reviewed for details on how a monitoring approach impacted subject safety data, data integrity, or monitoring costs.
Results
Twenty-two publications were identified. Three publications showed that SDV has some value for detection of not initially reported adverse events and centralized statistical monitoring (CSM) captures atypical trends. Fourteen publications showed little objective evidence of improved data integrity with traditional monitoring such as 100 % SDV and sponsor queries as compared to reduced SDV, CSM, and remote monitoring. Eight publications proposed a potential for significant cost reductions of monitoring by reducing SDV without compromising the validity of the trial results.
Conclusions
One hundred percent SDV is not a rational method of ensuring data integrity and subject safety based on the high cost, and this literature review indicates that reduced SDV is a viable monitoring method. Alternative methods of monitoring such as centralized monitoring utilizing statistical tests are promising alternatives but have limitations as stand-alone tools. Reduced SDV combined with a centralized, risk-based approach may be the ideal solution to reduce monitoring costs while improving essential data quality.
Journal Article
Data selves : more-than-human perspectives
\"As people use self-tracking devices and other digital technologies, they generate increasing quantities of personal information online. Lupton develops a fresh and intriguing perspective on how people make sense of and use their personal data, and what they know about others who use this information\"-- Provided by publisher.
Book
Reporting of data monitoring boards in publications of randomized clinical trials is often deficient: ACTTION systematic review
To examine whether primary reports of randomized clinical trials (RCTs) in six high-impact, general medical journals reported (1) whether or not a Data Monitoring Committee/Data and Safety Monitoring Board (DMC/DSMB) was used and (2) the composition of the responsibilities of the reported DSMB/DMCs.
Systematic review of RCTs published in 2014 in Annals of Internal Medicine, BMJ, NEJM, JAMA, JAMA Internal Medicine, and Lancet.
Of the 294 articles identified, 174 (59%) mentioned using a DMC/DSMB. Of these 174, 126 (72%) indicated at least one responsibility of the DMC/DSMB, 26% listed the names of the DMC/DSMB members, and another 14% listed both their names and affiliations. Only one article stated that a DSMB was not used. The remaining 119 articles did not report whether or not a DMC/DSMB was used, although 59 had previously stated in a clinical trials registry entry or a published protocol that a DMC/DSMB was to be used.
Considering the major role that DMC/DSMBs play in protecting participant safety, data quality, and interim analyses in RCTs, we recommend that authors of publications of RCTs report whether a DMC/DSMB was used and the responsibilities and members of DMC/DSMBs to increase transparency regarding study conduct.
Journal Article
DMC reports in the 21st century: towards better tools for decision-making
Data Monitoring Committees (DMCs) have the important task to protect the safety of current and future patients during the conduct of a clinical study. Unfortunately, their work is often made difficult by voluminous DMC reports that are poorly structured and difficult to digest. In this article, we suggest improved solutions. Starting from a principled approach and building upon previous proposals, we offer concrete and easily understood displays, including related computer code. While leveraging modern tools, the most important is that these displays support the DMC’s workflow in answering the relevant questions of interest. We hope that the adoption of these proposals can ease the task of DMCs, and importantly, lead to better decision-making for the benefit of patients.
Journal Article
The Australian National Rabbit Database: 50 yr of population monitoring of an invasive species
With ongoing introductions into Australia since the 1700s, the European rabbit (Oryctolagus cuniculus) has become one of the most widely distributed and abundant vertebrate pests, adversely impacting Australia's biodiversity and agroeconomy. To understand the population and range dynamics of the species and its impacts better, occurrence and abundance data have been collected by researchers and citizens from sites covering a broad spectrum of climatic and environmental conditions in Australia. The lack of a common and accessible repository for these data has, however, limited their use in determining important spatiotemporal drivers of the structure and dynamics of the geographical range of rabbits in Australia. To meet this need, we created the Australian National Rabbit Database, which combines more than 50 yr of historical and contemporary survey data collected from throughout the range of the species in Australia. The survey data, obtained from a suite of complementary monitoring methods, were combined with high‐resolution weather, climate, and environmental information, and an assessment of data quality. The database provides records of rabbit occurrence (689,265 records) and abundance (51,241 records, >120 distinct sites) suitable for identifying the spatiotemporal drivers of the rabbit's distribution and for determining spatial patterns of variation in its key life‐history traits, including maximum rates of population growth. Because all data are georeferenced and date stamped, they can be coupled with information from other databases and spatial layers to explore the potential effects of rabbit occurrence and abundance on Australia's native wildlife and agricultural production. The Australian National Rabbit Database is an important tool for understanding and managing the European rabbit in its invasive range and its effects on native biodiversity and agricultural production. It also provides a valuable resource for addressing questions related to the biology, success, and impacts of invasive species more generally. No copyright or proprietary restrictions are associated with the use of this data set other than citation of this Data Paper.
Journal Article
Prediction analysis of landslide displacement trajectory based on the gradient descent method with multisource remote sensing observations
Landslides can result in extensive casualties and huge economic losses. The accurate discrimination of the main slip direction and deformation trajectory is an important prerequisite for studying landslide formation mechanisms and designing landslide control schemes. In the process of landslide evolution over time, the main slip direction also changes dynamically and provides a comprehensive reflection of the landslide displacement state. However, few studies on this topic have been published. In this paper, a new methodology for analyzing slope stability is proposed based on three techniques: interferometric synthetic aperture radar (InSAR), unmanned aerial vehicle (UAV), and ground-based interferometric synthetic aperture radar (GB-InSAR). The Small Baseline Subset Interferometric SAR (SBAS-InSAR) technique is combined with an overall analysis of the study area to identify the regions of interest (ROIs) with large deformation and the starting target points, and the fusion results of radar deformation data (RDD) and digital surface model (DSM) data are used to fit the deformation surface field of the ROIs. The gradient descent approach is executed to obtain the running trajectory points of the target masses so that the main slip direction and displacement trajectory in the study area can be predicted at small scales. The measured data for the Hongshiyan landslide in Yunnan Province are used to verify the effectiveness of the method, and the predicted results are consistent with the actual landslide direction. The experimental results show that the method can exactly identify the deformation area, especially in the case of a fast-changing deformation trend. This approach can provide more accurate monitoring area results to support the rapid control and prevention of landslide hazards by analyzing the minimum pixel grid (i.e. points), as the smallest spatial unit at a time interval of minutes. The study shows that the method can efficiently combine space-Earth multisource monitoring data to clarify the main slide direction and improve the postslide trajectory prediction of the slope, which is beneficial for assessing disaster risks and improving landslide prevention and control effects, reflecting the engineering application value of the approach.
Journal Article
Inadequate planning and reporting of adjudication committees in clinical trials: Recommendation proposal
Adjudication committees (ACs) are recommended in randomized controlled trials (RCTs) to standardize the assessment of events. We aimed to assess the reporting and functioning of ACs (synonyms: clinical event committees, endpoint committees) in clinical trials.
We searched five high-impact-factor medical journals for reports of RCTs with clinical event endpoints published between January 1, 2004 and December 31, 2005.
ACs were reported in 33.4% of the 314 reports of RCTs. ACs were reported in 29.6% of trials with low risk of misclassification (i.e., “hard” main outcome), in 47.5% of trials with medium risk of misclassification (i.e., subjective main outcome and intervention delivered in a blinded fashion) and in 31% of trials with high risk of misclassification (i.e., subjective main outcome without intervention delivered in a blinded fashion). Selected cases to be adjudicated consisted largely of events identified by site investigators (93.3%). Data provided to the AC were reported for 47.4% of ACs.
Reporting of ACs is not fitted to the risk of biased misclassification. Important aspects of the functioning of ACs are insufficiently reported or raise methodological issues. We propose some recommendations for planning and reporting ACs in clinical trials.
Journal Article