Showing papers on "Electronic data capture published in 2003"

Electronic data capture and verification

Abstract: Apparatus for automatically building an electronic form for presentation to a user during a data capture process segregates the data capture intent behind the form from the presentation and execution of the form to a data capture user. In this way, the data capture process, including generation of the form and display of user input prompts, can be carried out on any computing platform independent of the system used to generate a data capture definition file that specifies the intent of the data capture requirements. The specification of data elements required during data capture, each having a type specification and a logical relationship relative to other data elements in a hierarchical structure are defined in a data capture definition file in a predetermined format. A data capture process executes the data capture definition file and automatically generates a plurality of visual displays for presentation to a user, each input screen comprising a plurality of user input areas corresponding to the data elements and physically positioned on the screen in a manner corresponding to the defined logical hierarchical structure.

Mobile clinical support system for pediatric emergencies

Abstract: This paper describes the process and methodology of designing and developing a mobile support system to triage abdominal pain in the emergency room (ER) of a hospital. Application of rough sets theory and fuzzy measures to data collected at Children's Hospital of Eastern Ontario allowed us to identify the most relevant clinical symptoms and signs while evaluating an abdominal pain patient. This information was used to develop a multilevel clinical algorithm that forms the reasoning module of a clinical support system. We describe a client system called Mobile Emergency Triage (MET) that is installed on Palm handheld and that can be used to triage a child irrespective of the available information. We present MET's functions allowing for the electronic data capture and wireless data transfer.

Conducting clinical trials over the internet: feasibility study.

Abstract: Can randomised controlled trials be successfully conducted over the internet? The authors report a feasibility study of such a trial in patients with osteoarthritis of the knee The possibility of conducting clinical trials entirely on line is an enticing but relatively unexplored medical application of the internet. The penetrance of the internet in the population offers the possibility of rapid recruitment of participants, and technological advances enable instant collection of data in a secure and confidential manner.1 These attributes could theoretically accelerate the evaluation of many compounds by cutting costs and reducing the duration of each study. Many components of an online trial, such as recruitment websites and electronic data capture technologies, have been separately described,2–4 but few attempts have been made to integrate these into a single process, and no study has evaluated the performance of such an endeavour. We set out to explore these issues by attempting a prototype double blind randomised placebo controlled trial in people recruited and followed entirely over the internet. The underlying intention in the design was to translate, as far as possible, all elements of a rigorous randomised placebo controlled trial into the virtual domain. To maximise the chance of success we chose to test glucosamine, a safe nutritional product popularly taken for symptoms of osteoarthritis of the knee,5 by using a trial design appropriate for this purpose. We designed a 14 week (2 week run-in, 12 week intervention) internet based placebo controlled randomised trial of glucosamine with biweekly scheduled online assessments of knee pain with the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) as the primary outcome measure.6 The WOMAC was developed and validated as a self report questionnaire, can be used on a computer screen, and is recommended as a primary outcome for osteoarthritis …

Statistical Approaches to Effectiveness Measurement and Outcome-Driven Re-Randomizations in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Studies

Abstract: The design of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia and Alzheimer's disease studies pose several statistical challenges, including issues related to performing multiple comparisons, defining effectiveness outcomes, and collecting and analyzing data from a design with multiple outcome-driven re-randomizations. We discuss the CATIE strategy for addressing many hypotheses within the context of one clinical trial while controlling the overall type I error rate. We provide motivation for the use of two effectiveness outcomes: time to all-cause discontinuation and composite endpoints that combine outcomes from multiple domains, such as efficacy, safety, cost-effectiveness, and quality of life. Methods for statistical analysis of an outcome-driven re-randomization trial are compared and evaluated. We describe analysis within each phase, analysis based on the first randomization or treatment algorithms, and repeated measures modeling. Finally, strategies are described for designing an electronic data collection system for trials with repeated outcome-driven re-randomizations.

Eliciting remote data entry system requirements for the collection of cancer clinical trial data.

Abstract: Information regarding the clinical course of a patient in a clinical trial is critical for cancer research. Nurses and clinical research associates must locate data stored in many formats and transfer data to paper case report forms. These forms are associated with a unique protocol document that specifies the set of data to be collected. This paper-based process involves a series of abstractions that pose a significant potential for error. Remote data entry has been advocated to facilitate and streamline the collection of clinical trial data. A systematic process to elicit system requirements from end-users is described as an approach to integrate computer technology with cancer research. Nurses and clinical research associates, as end-users of remote data entry, can provide invaluable input into the requirements necessary to develop an efficient and practical system. By incorporating this input, remote data entry can offer a potential benefit for preserving data integrity.

Globalization of clinical trials

Abstract: Based on reviews of the Japanese clinical trial situation in lung cancer, gastric cancer, prostate cancer and breast cancer, it was clear that much progress has been made in short time. There are considerable differences between Japan and the West and also differences between clinical areas in Japan. For regulatory purposes bridging studies have become increasingly important. Use of identical protocols are required for effective bridging. Participations in global phase III trials is the best way of achieving registration in Japan. For successful global trials in Japan it is important to include Japanese investigators in the preparation of the protocol and to recognise the challenges facing such a project. Clinical practice in diagnosis and treatment have many differences, thus it is recommended to have clear and detailed information in the protocol. Hard end points like survival are important since they are not biased by cultural differences. There are clear difficulties with HE or QOL outcomes. The emergence of focus on evidence based medicine is also happening in Japan and will help to harmonize documentation across the world. For large adjuvant or prevention cancer global trials are essential. To facilitate global studies further development of infrastructure is necessary in Japan. Use of electronic data capture web based communication etc. will help overcome communication difficulties. Other improvements that will make Japanese participation in global trials easier and better include establishment of clinical trial centre at each hospital, introduction of trial coordinators or study nurses and an improved collaboration with company staff. A critical issue that also need addressing is agreement of centre target recruitment. We need to introduce a new flexible system in Japan if participation in global trial is to be optimised. If we can address these issues Japanese investigators and collaborative groups should be able to initiate and lead global trials in the future.

Open source or commercial products for electronic data capture in clinical trials? a scorecard comparison

Abstract: Collection and organization of data in clinical trials requires a sophisticated information management system. An ideal system should be easily accessible over web-technology and should provide high security of data. When deciding for a solution meanwhile even mid- and big-sized companies also evaluate open-source platforms against pure commercial solutions as the use of open-source products seems to get more and more feasible: early open-source disadvantages like limited support and limited user-friendliness seem to disappear. With this work the authors intended to discuss a basic scheme for which software and strategy to choose: objective was to develop a scorecard for decision support with parameters of the trial, user-needs, scale/dimension of the trial, financial budget, IT-resources and long term objectives of the companies IT-strategy. The scorecard can be obtained free from the authors.

CommLog/spl copy/: A communication log system for clinical trials

Abstract: Thanks to the advent of information technologies, the emergence of commercial products for electronic clinical trials has improved many aspects of conducting clinical trials. While there are many new options available to facilitate the collection of patient data, little advancements have been made in the way in which information generated from the coordination of a clinical trial is managed. The coordination of a clinical trial has proven to have a significant impact on the quality and economy of clinical trials. The Vanderbilt Coordinating Center has designed and implemented a communication log system (CommLog/spl copy/) to streamline the coordination of clinical trials in order to improve the quality and economy of clinical trials. The CommLog/spl copy/ has been operational for several industry-sponsored phase II/III clinical trails and has provided a knowledge base for the studies and repository for useful study information.

The Clinical Data Interchange Standards Consortium Laboratory Model: Standardizing Laboratory Data Interchange in Clinical Trials

Abstract: The Laboratory Data Standards Model team of the Clinical Data Interchange Standards Consortium (CDISC) has defined a model for representing, in a standardized manner, the laboratory data generated during the conduct of clinical trials. The CDISC Laboratory Data Standards Model is the first step in proposing independent standards for the interchange of clinical trial laboratory data. Standards will decrease the time and resources that are required to exchange data by stakeholders in the pharmaceutical development process. Cost containment and improved data quality should result from the adoption of such a standard for interchanging laboratory data.

Use wireless web services to improve patient compliance in clinical drug trials

Abstract: Outpatient clinical drug trials and therapies conducted in the patients' natural environments not only drastically reduce clinical trial costs but also make the results more accurate. However, a major challenge in outpatient trials is to monitor the patients and make sure that they are compliant with trial protocols. In this paper, we first discuss why patient compliance is so important in clinical trials and identify two crucial compliance issues: drug dosing compliance and symptom self-report compliance. We suggest that pervasive wireless EDC (Electronic Data Capture) devices powered by web services can potentially provide solutions to those outpatient compliance issues. A wireless front-end architecture based on short-range wireless networks is proposed. Then, we survey current and emerging technologies that could be used to implement such clinical trial information systems. We put special emphases on core technologies including multimodal user interfaces, interoperable back end services and security.