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Clinical Trials (1,864 Books)


Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

 
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Final Draft Pilot Study to Estimate Asbestos Exposure from Vermicu...

By: Environmental Protection Agency

Excerpt: This project began in November 2000 as a preliminary or pilot study of the analysis of vermiculite attic insulation. There were two general objectives for the pilot study: (1) obtain a rough estimate of amount of asbestos in attics having vermiculite attic insulation; and (2) obtain a rough estimate of a person’s exposure to asbestos while performing common household activities. The budget and the timing for the completion of the both parts of this pilot study p...

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Controlled Clinical Studies of Air Pollutant Exposure : Evaluating...

By: Jack D. Hackney

Government Reference Publication

Introduction: This paper focuses on clinical studies of human volunteers deliberately exposed to specific air pollutants. Most such investigations are performed for the express purpose of guiding air quality regulatory decisions. They establish atmospheric conditions in a controlled laboratory setting which are considered relevant to actual ambient polluted atmospheres and attempt to document any health-related effects which result from breathing the laboratory atmospher...

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Statement of Work : Clinical Research Support Services, 02/11/2005...

By: Department of Health and Human Services

This contract will provide support to principal investigators (PIs) in the Office of Clinical Research (OCR) and Division of Intramural Research (DIR) at the National Institute of Environmental Health Sciences (NIEHS) for all types of clinical research studies, including both observational clinical research studies and interventional clinical trials. Examples of observational studies to be covered by this contract include case report and case series, casecontrol, cross-s...

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Plos One : Partake Survey of Public Knowledge and Perceptions of C...

By: David Joseph Diemert

Description : Results suggest the Indian public is aware of some key features of clinical research (e.g., purpose, value, voluntary nature of participation), and supports clinical research in general but is unaware of other key features (e.g., compensation, confidentiality, protection of human participants) and exhibits some distrust in the conduct and reporting of clinical trials. Larger, cross-cultural surveys are required to inform educational programs addressing these issues.

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Clinical Trials in Cancer Research

By: Edmund A. Gehan

Government Reference Publication

Introduction: The randomized clinical trial was first used for the evaluation of cancer treatments in the mid-1950s (I). Inonly two decades, it has proven to be a useful way oicvlutintgh e relative r.ifcctiveneuftrriitmcnt, and bodv ui knowled-re has hecn developed which provides objective data about cancer treatments. The organization of comparative clinical trials through the cooperative groups program sponsored by the National Cancer Institute in the U.S. and clinical...

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Plos One : Enrichment and Stratification for Predementia Alzheimer...

By: Antony Bayer

Description : The tau and amyloid pathobiological processes underlying Alzheimer disease (AD) progresses slowly over periods of decades before clinical manifestation as mild cognitive impairment (MCI), then more rapidly to dementia, and eventually to end-stage organ failure. The failure of clinical trials of candidate disease modifying therapies to slow disease progression in patients already diagnosed with early AD has led to increased interest in exploring the possibil...

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Ethical Conduct of Clinical Research Involving Children

By: Field Mj

Description: Concerns about the adequacy of the system for protecting child participants in research, combined with the public commitment to expanding clinical research involving children, provided the impetus for this Institute of Medicine (IOM) report, which was requested in the Best Pharmaceuticals for Children Act of 2002 (P.L. 107-109). The legislation charged the IOM with preparing a report that reviewed federal regulations, reports, and research and that made reco...

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Plos One : Using Central Irbs for Multicenter Clinical Trials in t...

By: T. Mark Doherty

Description : Research institutions differ in their willingness to defer to a single, central institutional review board (IRB) for multicenter clinical trials, despite statements from the FDA, OHRP, and NIH in support of using central IRBs to improve the efficiency of conducting trials. The Clinical Trials Transformation Initiative (CTTI) supported this project to solicit current perceptions of barriers to the use of central IRBs and to formulate potential solutions. We ...

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Opportunities to Address Clinical Research Workforce Diversity Nee...

By: Jong-on Hahm

Description: The increasing diversity and age of the U.S. population present new challenges for the U.S. clinical research community, whose role is to develop healthcare therapies and paradigms from the knowledge gained in basic research. A particularly a

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Public Engagement and Clinical Trials : New Models and Disruptive ...

By: National Academies Press US

Description: Rapid advances in biomedical research have drawn attention to the critical need for an effective clinical trial system that can generate the evidence needed to translate discoveries into improved patient care, and illuminate targets for furth

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Transforming Clinical Research in the United States : Challenges a...

By: National Academies Press US

Description: To plan and execute a clinical trial today can take years and cost hundreds of millions of dollars. In the past, the United States was considered the best place to conduct clinical trials because of the right mix of clinical and scientific ex

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Plos One : the Geographical Distribution of Leadership in Globaliz...

By: Nancy M. Sawtell

Description : Despite patient enrolment efforts, the involvement of researchers from nontraditional locations in trial management as measured by their contribution to manuscript writing is modest. This division of labor has significant implications for the scientific and ethical integrity of global clinical research

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Plos One : the Value of Source Data Verification in a Cancer Clini...

By: Salomon M. Stemmer

Description : Quality assurance methods used in clinical trials should be informed by empirical evidence. In this empirical comparison, SDV was expensive and identified random errors that made little impact on results and clinical conclusions of the trial. Central monitoring using an external data source was a more efficient approach for the primary outcome of OS. For the subjective outcome objective response, an independent blinded review committee and tracking system t...

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A Pilot Study for Near Real-Time Aerosol Modeling and Air Quality ...

By: Environmental Protection Agency

Excerpt: Partner with the National Oceanic and Atmospheric Administration (NOAA) and the U.S. Environmental Protection Agency (EPA) for technology transfer in the area of grid-based photochemical modeling -- Apply and evaluate the Community Multiscale Air Quality (CMAQ) stateof- science photochemical modeling system on an ongoing basis with special emphasis on PM2.5 predictions -- Assess the potential usefulness of grid-based photochemical models to provide air quality f...

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Content Evaluation Pilot Study

By: J. Gary Van Nest

Statistical Reference Document

Excerpt: The Content Evaluation Pilot Study of the 1982 Economic Censuses was designed to determine the feasibility of conducting a full scale Content Evaluation of the 1987 Economic Censuses for the more complex items on the census questionnaire. The study was also intended to identify problems respondents have had in reporting accurate figures for the more complex items on the census questionnaires and to develop recommendations that will help reduce these reporting pr...

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A Pilot Study for Near Real-Time Aerosol Modeling and Air Quality ...

By: Alice Gilliland

Excerpt: The poster will present the objectives and initial results of a pilot study conducted as a partnership between the U.S. Environmental Protection Agency (U.S. EPA), National Oceanic and Atmospheric Administration (NOAA), and the New York State Department of Environmental Conservation (NYSDEC). The primary objectives of this study are to implement, operate, and evaluate an automated, numerical, model-based air quality forecast system to provide daily predictions o...

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Content Evaluation Pilot Study

By: J. Gary Van Nest

Statistical Reference Document

Excerpt: 1. Executive Summarv The Content Evaluation Pilot Study of the 1982 Economic Censuses was designed to determine the feasibility of conducting a full scale Content Evaluation of the 1987 Economic Censuses for the more complex items on the census questionnaire. The study was also intended to identify problems respondents have had in reporting accurate figures for the more complex items on the census questionnaires and to develop recommendations that will help redu...

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Randomization in Cancer Clinical Trials : Permutation Test and Dev...

By: Yasuo Ohashi

Government Reference Publication

Excerpt: As seen in the guidelines by Simon and Wittes (I), high quality is being required in cancer clinical trial data for raising the reliability and comparability of trials, and this pressure from abroad is now influencing the design and management of cancer clinical trials in Japan. Until a few years ago, the randomization has been done almost exclusively by the envelop method in Japan, and a high rate of ineligibility and protocol violations have often deteriorated...

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New Drug Development: Estimating Entry from Human Clinical Trials

By: Christopher P. Adams

Government Reference Publication

Abstract: This paper analyses a detailed data set on drugs in human clinical trials around the world between 1989 and 2002. The data provides information on the probabilities with which drugs successfully complete the different phases of the trials and the durations of successful completions. The paper shows that success rates and durations can vary substantially across observable characteristics of the drugs, including primary indication, originating company, route of a...

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Feasibility of Using Subject-Collected Dust Samples in Epidemiolog...

By: Samuel J. Arbes

Government Reference Publication

Excerpt: Studies of indoor allergen exposures are often limited by the cost and logistics of sending technicians to homes to collect dust. In this study we evaluated the feasibility of having subjects collect their own dust samples. The objectives were to compare allergen concentrations between subject- and technician-collected samples and to examine the sample return rate. Using a dust collection device and written instructions provided to them by mail, 102 subjects col...

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