Search results for: clinical-trial-registries

Clinical Trial Registries

Author : MaryAnn Foote
File Size : 84.52 MB
Format : PDF, Docs
Download : 493
Read : 727
Download »
ICMJE editors and other journal editors require registration of clinical trial information on publicly available Web sites before enrollment of study subjects. Not only does this book discuss the genesis of these requirements, it also provides practical information for researchers and sponsors on how to establish a workflow for a clinical registry project, how to file to a registry, and how to post results.

Developing a National Registry of Pharmacologic and Biologic Clinical Trials

Author : Committee on Clinical Trial Registries
File Size : 26.61 MB
Format : PDF, Kindle
Download : 536
Read : 969
Download »
To improve public confidence in clinical research, a number of public and private groups have called for a publicly accessible, comprehensive, and transparent registry of relevant information on clinical trials for drugs and biologics. The public and various entities within the medical community (health care providers, researchers, medical journal editors, pharmaceutical companies, health insurers, and regulators) have different expectations and perceived needs regarding a public clinical trial registry. The IOM Committee on Clinical Trial Registries hosted a workshop on June 27, 2005, to obtain much-needed input from members of the public, public advocate groups, and the broader community of journal editors, pharmaceutical and biotech leaders, NIH, and the FDA. Participants discussed the data elements that have been at the core of debate and commented on issues of compliance and implementation of a national clinical trial registry. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report inlcudes discussions at the workshop centered on the following five concepts, and are described within this report: 1) Purpose, 2) Which Trials to Include, 3) Delayed Disclosure Mechanism, 4) Reporting Results of Completed Trials, and 5) Compliance.

Journal of the National Cancer Institute

Author :
File Size : 53.70 MB
Format : PDF, Docs
Download : 142
Read : 906
Download »

Transparent and Reproducible Social Science Research

Author : Garret Christensen
File Size : 75.23 MB
Format : PDF, Mobi
Download : 190
Read : 374
Download »
Recently, social science has had numerous episodes of influential research that was found invalid when placed under rigorous scrutiny. The growing sense that many published results are potentially erroneous has made those conducting social science research more determined to ensure the underlying research is sound. Transparent and Reproducible Social Science Research is the first book to summarize and synthesize new approaches to combat false positives and non-reproducible findings in social science research, document the underlying problems in research practices, and teach a new generation of students and scholars how to overcome them. Understanding that social science research has real consequences for individuals when used by professionals in public policy, health, law enforcement, and other fields, the book crystallizes new insights, practices, and methods that help ensure greater research transparency, openness, and reproducibility. Readers are guided through well-known problems and are encouraged to work through new solutions and practices to improve the openness of their research. Created with both experienced and novice researchers in mind, Transparent and Reproducible Social Science Research serves as an indispensable resource for the production of high quality social science research.

Extending Medicare Reimbursement in Clinical Trials

Author : Institute of Medicine
File Size : 64.23 MB
Format : PDF
Download : 737
Read : 367
Download »
Increasingly over the past five years, uncertainty about reimbursement for routine patient care has been suspected as contributing to problems enrolling people in clinical trials. Clinical trial investigators cannot guarantee that Medicare will pay for the care required, and they must disclose this uncertainty to potential participants during the informed consent process. Since Medicare does not routinely "preauthorize" care (as do many commercial insurers) the uncertainty cannot be dispelled in advance. Thus, patients considering whether to enter trials must assume that they may have to pay bills that Medicare rejects simply because they have enrolled in the trial. This report recommends an explicit policy for reimbursement of routine patient care costs in clinical trials. It further recommends that HCFA provide additional support for selected clinical trials, and that the government support the establishment of a national clinical trials registry. These policies (1) should assure that beneficiaries would not be denied coverage merely because they have volunteered to participate in a clinical trial; and (2) would not impose excessive administrative burdens on HCFA, its fiscal intermediaries and carriers, or investigators, providers, or participants in clinical trials. Explicit rules would have the added benefit of increasing the uniformity of reimbursement decisions made by Medicare fiscal intermediaries and carriers in different parts of the country. Greater uniformity would, in turn, decrease the uncertainty about reimbursement when providers and patients embark on a clinical trial.

Product Safety Liability Reporter

Author :
File Size : 31.81 MB
Format : PDF, Docs
Download : 381
Read : 400
Download »

Journal of the National Cancer Institute

Author :
File Size : 29.69 MB
Format : PDF, ePub
Download : 866
Read : 365
Download »
"Summaries of papers" contained in the journal accompany each issue, 19--

Issues in Biological and Life Sciences Research 2011 Edition

Author :
File Size : 21.92 MB
Format : PDF, ePub, Docs
Download : 142
Read : 871
Download »
Issues in Biological and Life Sciences Research: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Biological and Life Sciences Research. The editors have built Issues in Biological and Life Sciences Research: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Biological and Life Sciences Research in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Biological and Life Sciences Research: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

Food and Drug Law Journal

Author :
File Size : 27.75 MB
Format : PDF, ePub
Download : 573
Read : 496
Download »

Bulletin of the World Health Organization

Author : World Health Organization
File Size : 49.75 MB
Format : PDF, Docs
Download : 315
Read : 712
Download »

Understanding Clinical Research

Author : Renato D. Lopes
File Size : 78.44 MB
Format : PDF, ePub, Docs
Download : 814
Read : 611
Download »
A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials

The Australian Journal of Physiotherapy

Author :
File Size : 22.43 MB
Format : PDF, Mobi
Download : 514
Read : 934
Download »

Publication Bias in Meta Analysis

Author : Hannah R. Rothstein
File Size : 29.1 MB
Format : PDF, ePub
Download : 914
Read : 1224
Download »
Publication bias is the tendency to decide to publish a study based on the results of the study, rather than on the basis of its theoretical or methodological quality. It can arise from selective publication of favorable results, or of statistically significant results. This threatens the validity of conclusions drawn from reviews of published scientific research. Meta-analysis is now used in numerous scientific disciplines, summarizing quantitative evidence from multiple studies. If the literature being synthesised has been affected by publication bias, this in turn biases the meta-analytic results, potentially producing overstated conclusions. Publication Bias in Meta-Analysis examines the different types of publication bias, and presents the methods for estimating and reducing publication bias, or eliminating it altogether. Written by leading experts, adopting a practical and multidisciplinary approach. Provides comprehensive coverage of the topic including: Different types of publication bias, Mechanisms that may induce them, Empirical evidence for their existence, Statistical methods to address them, Ways in which they can be avoided. Features worked examples and common data sets throughout. Explains and compares all available software used for analysing and reducing publication bias. Accompanied by a website featuring software, data sets and further material. Publication Bias in Meta-Analysis adopts an inter-disciplinary approach and will make an excellent reference volume for any researchers and graduate students who conduct systematic reviews or meta-analyses. University and medical libraries, as well as pharmaceutical companies and government regulatory agencies, will also find this invaluable.

Clinical Research and the Law

Author : Patricia M. Tereskerz
File Size : 32.71 MB
Format : PDF, ePub
Download : 308
Read : 606
Download »
The legal implications of conducting clinical research and trials are becoming more complex. Everyone involved in clinical research increasingly needs to be aware of not only the ethical issues at stake but also how the law affects medical practice and research. Much of clinical research and trial law and litigation is comparatively recent and researchers need to ensure current compliance on a wide range of issues. Including: standards and duty of care informed consent conflicts of interest research contracts establishing clinical trials the disclosure and withholding of clinical trial results Clinical Research and the Law comprehensively discusses these topics and provides the answers to the legal questions and potential pitfalls encountered in medical research. It is an up-to-date, practical guide for clinical investigators and their institutional administrators, particularly risk managers and research administrators, as well as healthcare administrators and members of institutional review boards. This book is also a key resource for medical students, postgraduate research students, practicing attorneys and counselors for teaching hospitals and institutions undertaking clinical research and contract research organizations.

WHO Drug Information

Author :
File Size : 49.8 MB
Format : PDF, Kindle
Download : 340
Read : 351
Download »

Wiley Encyclopedia of Clinical Trials

Author : Lisa Marie Sullivan
File Size : 41.39 MB
Format : PDF, Mobi
Download : 643
Read : 613
Download »
Here you'll find more than 500 entries from the world's leading experts in the field on the basic concepts, methodologies, and applications in clinical trials. The range of topics includes: basic statistical concepts, design and analysis of clinical trials, ethics, regulatory issues, and methodologies for clinical data management and analysis

Assessing the safety of our nation s drug supply

Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
File Size : 22.75 MB
Format : PDF, Mobi
Download : 515
Read : 711
Download »

Ceylon Medical Journal

Author :
File Size : 22.82 MB
Format : PDF
Download : 952
Read : 828
Download »

Pharmacotherapy Self Assessment Program

Author : American College of Clinical Pharmacy
File Size : 87.45 MB
Format : PDF, ePub
Download : 170
Read : 481
Download »

The Lancet

Author :
File Size : 65.6 MB
Format : PDF
Download : 157
Read : 339
Download »