Supporting the clinical trial recruitment process through the grid

Patient recruitment for clinical trials and studies is a large-scale task. To test a given drug for example, it is desirable that as large a pool of suitable candidates is used as possible to support reliable assessment of often moderate effects of the drugs. To make such a recruitment campaign successful, it is necessary to efficiently target the petitioning of these potential subjects. Because of the necessarily large numbers involved in such campaigns, this is a problem that naturally lends itself to the paradigm of Grid technology. However the accumulation and linkage of data sets across clinical domain boundaries poses challenges due to the sensitivity of the data involved that are atypical of other Grid domains. This includes handling the privacy and integrity of data, and importantly the process by which data can be collected and used, and ensuring for example that patient involvement and consent is dealt with appropriately throughout the clinical trials process. This paper describes a Grid infrastructure developed as part of the MRC funded VOTES project (Virtual Organisations for Trials and Epidemiological Studies) at the National e-Science Centre in Glasgow that supports these processes and the different security requirements specific to this domain

Initial experiences in developing e-health solutions across Scotland

The MRC funded Virtual Organisations for Trials and Epidemiological Studies (VOTES) project is a collaborative effort between e-Science, clinical and ethical research centres across the UK including the universities of Oxford, Glasgow, Imperial, Nottingham and Leicester. The project started in September 2005 and is due to run for 3 years. The primary goal of VOTES is to develop a reusable Grid framework through which a multitude of clinical trials and epidemiological studies can be supported. The National e-Science Centre (NeSC) at the University of Glasgow are looking at developing the Scottish components of this framework. This paper presents the initial experiences in developing this framework and in accessing and using existing data sets, services and software across the NHS in Scotland

Leadership considerations for executive vice chairs, new chairs, and chairs in the 21st century.

The need to fulfill academic goals in the context of significant economic challenges, new regulatory requirements, and ever-changing expectations for leadership requires continuous adaptation. This paper serves as an educational resource for emerging leaders from the literature, national leaders, and other “best practices” in the following domains: 1. Mentorship; 2. Faculty Development; 3. Promotion; 4. Demonstrating value in each of the academic missions; 5. Marketing and communications; and 6. Barrier

Comparison of Electronic Record Types Concerning the Applicability for Patient Recruitment (Preprint)

Background Clinical trials constitute an important pillar in medical research. It is beneficial to support recruitment for clinical trials using software tools, so-called patient recruitment support systems; however, such information technology systems have not been frequently used to date. Because medical information systems' underlying data collection methods strongly influence the benefits of implementing patient recruitment support systems, we investigated patient recruitment support system requirements and corresponding electronic record types such as electronic medical record, electronic health record, electronic medical case record, personal health record, and personal cross-enterprise health record. Objective The aim of this study was to (1) define requirements for successful patient recruitment support system deployment and (2) differentiate and compare patient recruitment support system-relevant properties of different electronic record types. Results Patient recruitment support system requirements (n=16) were grouped into 4 categories (consent management, patient recruitment management, trial management, and general requirements). All 16 requirements could be partially met by at least 1 type of electronic record. Only 1 requirement was fully met by all 5 types. According to our analysis, personal cross-enterprise health records fulfill most requirements for patient recruitment support systems. They demonstrate advantages especially in 2 domains (1) supporting patient empowerment and (2) granting access to the complete medical history of patients. Conclusions In combination with patient recruitment support systems, personal cross-enterprise health records prove superior to other electronic record types, and therefore, this integration approach should be further investigated

Patient-powered research networks: building capacity for conducting patient-centered clinical outcomes research.

The Patient-Centered Outcomes Research Institute (PCORI) recently launched PCORnet to establish a single inter-operable multicenter data research network that will support observational research and randomized clinical trials. This paper provides an overview of the patient-powered research networks (PPRNs), networks of patient organizations focused on a particular health condition that are interested in sharing health information and engaging in research. PPRNs will build on their foundation of trust within the patient communities and draw on their expertise, working with participants to identify true patient-centered outcomes and direct a patient-centered research agenda. The PPRNs will overcome common challenges including enrolling a diverse and representative patient population; engaging patients in governance; designing the data infrastructure; sharing data securely while protecting privacy; prioritizing research questions; scaling small networks into a larger network; and identifying pathways to sustainability. PCORnet will be the first distributed research network to bring PCOR to national scale

Prototype of running clinical trials in an untrustworthy environment using blockchain.

Monitoring and ensuring the integrity of data within the clinical trial process is currently not always feasible with the current research system. We propose a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially more trustworthy. We use raw data from a real completed clinical trial, simulate the trial onto a proof of concept web portal service, and test its resilience to data tampering. We also assess its prospects to provide a traceable and useful audit trail of trial data for regulators, and a flexible service for all members within the clinical trials network. We also improve the way adverse events are currently reported. In conclusion, we advocate that this service could offer an improvement in clinical trial data management, and could bolster trust in the clinical research process and the ease at which regulators can oversee trials

Family in Rehabilitation, Empowering Carers for Improved Malnutrition Outcomes: Protocol for the FREER Pilot Study

Interventions to improve the nutritional status of older adults and the integration of formal and family care systems are critical research areas to improve the independence and health of aging communities and are particularly relevant in the rehabilitation setting.The primary outcome aimed to determine if the FREER (Family in Rehabilitation: EmpowERing Carers for improved malnutrition outcomes) intervention in malnourished older adults during and postrehabilitation improve nutritional status, physical function, quality of life, service satisfaction, and hospital and aged care admission rates up to 3 months postdischarge, compared with usual care. Secondary outcomes evaluated include family carer burden, carer services satisfaction, and patient and carer experiences. This pilot study will also assess feasibility and intervention fidelity to inform a larger randomized controlled trial.This protocol is for a mixed-methods two-arm historically-controlled prospective pilot study intervention. The historical control group has 30 participants, and the pilot intervention group aims to recruit 30 patient-carer pairs. The FREER intervention delivers nutrition counseling during rehabilitation, 3 months of postdischarge telehealth follow-up, and provides supportive resources using a novel model of patient-centered and carer-centered nutrition care. The primary outcome is nutritional status measured by the Scored Patient-Generated Subjective Global Assessment Score. Qualitative outcomes such as experiences and perceptions of value will be measured using semistructured interviews followed by thematic analysis. The process evaluation addresses intervention fidelity and feasibility.Recruitment commenced on July 4, 2018, and is ongoing with eight patient-carer pairs recruited at the time of manuscript submission.This research will inform a larger randomized controlled trial, with potential for translation to health service policies and new models of dietetic care to support the optimization of nutritional status across a continuum of nutrition care from rehabilitation to home.Australian New Zealand Clinical Trials Registry Number (ACTRN) 12618000338268; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374608&isReview=true (Archived by WebCite at http://www.webcitation.org/74gtZplU2).DERR1-10.2196/12647