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A paradigm shift in pharmacogenomics and in the diagnosis of genetic inherited diseases and infectious diseases is unfolding as the result of implementation of next generation genomic technologies.

An Information Technology Surrogate for Religion: The Veneration of Deceased Family in Online Games

Quality Assurance for Clinical Trials. PubMed Central. Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial , the cooperative group prepares a protocol to define the goals of the trial , the rationale for its design, and the details of the treatment procedure to be followed.

The Radiological Physics Center RPC is one of several quality assurance QA offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable.

The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials 4.

The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. Quality of clinical trials : A moving target. Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging.

To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process.

The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action.

With an objective to improve quality , the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems.

The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

The quality of registration of clinical trials. Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems.

However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-meaningful. If these studies are accurate, this negates the possible benefits of registration of clinical trials. More than half of the records were registered after recruitment of the first participant. The name of a contact person was available in Either an email address or a phone number was present in Although a drug name or company serial number was almost always provided, other drug intervention specifics were often omitted from registration.

Of reported outcomes, Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records.

The Quality of Registration of Clinical Trials. Background Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Conclusions Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. Enhancing clinical evidence by proactively building quality into clinical trials.

Stakeholders across the clinical trial enterprise have expressed concern that the current clinical trial enterprise is unsustainable.

The cost and complexity of trials have continued to increase, threatening our ability to generate reliable evidence essential for making appropriate decisions concerning the benefits and harms associated with clinical interventions. Overcoming this inefficiency rests on improving protocol design, trial planning, and quality oversight. The Clinical Trials Transformation Initiative convened a project to evaluate methods to prospectively build quality into the scientific and operational design of clinical trials " quality -by-design" , such that trials are feasible to conduct and important errors are prevented rather than remediated.

A working group evaluated aspects of trial design and oversight and developed the Clinical Trials Transformation Initiative quality -by-design principles document, outlining a series of factors generally relevant to the reliability of trial conclusions and to patient safety. These principles were then applied and further refined during a series of hands-on workshops to evaluate their utility in facilitating proactive, cross-functional dialogue, and decision-making about trial design and planning.

Following these workshops, independent qualitative interviews were conducted with 19 workshop attendees to explore the potential challenges for implementing a quality -by-design approach to clinical trials. The Clinical Trials Transformation Initiative project team subsequently developed recommendations and an online resource guide to support implementation of this approach.

The Clinical Trials Transformation Initiative quality -by-design principles provide a framework for assuring that clinical trials adequately safeguard participants and provide reliable information on which to make decisions on the effects of treatments. The quality -by-design workshops highlighted the value of active discussions incorporating the.

Clinical trial quality : From supervision to collaboration and beyond. Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct.

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research.

This paper is devoted to various choices of data quality metrics. They are categorized by study status, e. Some general quality metrics frequently used are also introduced.

This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials.

We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry. Introduction The benefits of clinical trials registration include improved transparency on clinical trials for healthcare workers and patients, increased accountability of trialists, the potential to address publication bias and selective reporting, and possibilities for research collaboration and prioritization.

However, poor quality of information in registered records of trials has been found to undermine these benefits in the past. Trialists' increasing experience with trial registration and recent developments in registration systems may have positively affected data quality. This study was conducted to investigate whether the quality of registration has improved.

Methods We repeated a study from , using the same methods and the same research team. Results were compared to the equivalent assessments from our previous study. Results There was a small and not statistically significant increase from There was a significant increase from Approximately half of all trials continued to be retrospectively registered.

Discussion There have been small but significant improvements in the quality of registration since Important problems with quality remain and continue to constitute an impediment to the. Linking quality indicators to clinical trials : an automated approach.

Abstract Objective Quality improvement of health care requires robust measurable indicators to track performance. However identifying which indicators are supported by strong clinical evidence, typically from clinical trials , is often laborious. This study tests a novel method for automatically linking indicators to clinical trial registrations. Design A set of quality of care indicators for 22 common conditions drawn from the CareTrack study were automatically mapped to outcome measures reported in 13 trials from ClinicalTrials.

Intervention Text mining methods extracted phrases mentioning indicators and outcome phrases, and these were compared using the Levenshtein edit distance ratio to measure similarity. Main Outcome Measure Number of care indicators that mapped to outcome measures in clinical trials. Of the indicators known to have evidence behind them, only 5. Conclusions We automatically linked indicators to clinical trial registrations with high precision.

Whilst the majority of quality indicators studied could be directly linked to research evidence, a small portion could not and these require closer scrutiny. It is feasible to support the process of indicator development using automated methods to identify research evidence. Background Historically, only partial assessments of data quality have been performed in clinical trials , for which the most common method of measuring database error rates has been to compare the case report form CRF to database entries and count discrepancies.

Importantly, errors arising from medical record abstraction and transcription are rarely evaluated as part of such quality assessments. We characterize the average source-to-database error rate This error rate was significantly lower than the average of published error rates for source-to-database audits, and was similar to CRF-to-database error rates reported in the published literature.

We attribute this largely to an absence of medical record abstraction on the trials we examined, and to an outpatient setting characterized by less acute patient conditions. Conclusions Historically, medical record abstraction is the most significant source of error by an order of magnitude, and should be measured and managed during the course of clinical trials. Source-to-database error rates are highly dependent on the amount of structured data collection in the clinical setting and on the complexity of the medical record, dependencies that should be considered when developing data quality benchmarks.

A systematic review of the quality of homeopathic clinical trials. Background While a number of reviews of homeopathic clinical trials have been done, all have used methods dependent on allopathic diagnostic classifications foreign to homeopathic practice. In addition, no review has used established and validated quality criteria allowing direct comparison of the allopathic and homeopathic literature.

Methods In a systematic review, we compared the quality of clinical-trial research in homeopathy to a sample of research on conventional therapies using a validated and system-neutral approach. All clinical trials on homeopathic treatments with parallel treatment groups published between — in English were selected. All were evaluated with an established set of 33 validity criteria previously validated on a broad range of health interventions across differing medical systems.

Criteria covered statistical conclusion, internal, construct and external validity. Reliability of criteria application is greater than 0. Results 59 studies met the inclusion criteria. There was practically no replication of or overlap in the conditions studied and most studies were relatively small and done at a single-site.

Compared to research on conventional therapies the overall quality of studies in homeopathy was worse and only slightly improved in more recent years. Conclusions Clinical homeopathic research is clearly in its infancy with most studies using poor sampling and measurement techniques, few subjects, single sites and no replication.

Many of these problems are correctable even within a "holistic" paradigm given sufficient research expertise, support and methods. The clinical research triad: how can we ensure quality in out-sourced clinical trials? The importance of quality within clinical trials cannot be underestimated.

An Information Technology Surrogate for Religion: The Veneration of Deceased Family in Online Games

Abstracts are listed in alphabetical order. Caregivers and social workers provided positive feedback. Caregiver participation rates were lower than anticipated. Participants recommended continuing the intervention. Impact: This intervention should be continued with efforts to adapt sessions to a nonacademic community healthcare setting. This work reports the electrical characterization of inkjet-printed Ge 2 Sb 2 Te 5 GST thin films to explore the possibility of an all-printed phase-change memory PCM device.

Quality Assurance for Clinical Trials. PubMed Central. Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial , the cooperative group prepares a protocol to define the goals of the trial , the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center RPC is one of several quality assurance QA offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable.

L-R Douglas L. Starkey 17 , Peter P. Holwager 7 , William M. Fraser 10 , and Bruce G. Toy


Financial Management and Accountability Programme (FINMAP III). I observed case backlogs across several entities in government. ethical requirements and plan and perform the audit to obtain reasonable of the assets of departed Asians declared under Form PRO/4 Two x-rays not working.


Student Abstracts

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