Methods And Impact Of Controlled Therapeutic Trials In Cancer

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Small Clinical Trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309171148
Total Pages : 221 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

The Prevention and Treatment of Missing Data in Clinical Trials

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 030918651X
Total Pages : 163 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council

Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Sharing Clinical Trial Data

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Author : Agency for Health Care Research and Quality (U.S.)
Publisher : Government Printing Office
ISBN 13 : 1587634236
Total Pages : 236 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide by : Agency for Health Care Research and Quality (U.S.)

Download or read book Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide written by Agency for Health Care Research and Quality (U.S.) and published by Government Printing Office. This book was released on 2013-02-21 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

The Social Impact of AIDS in the United States

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309046289
Total Pages : 337 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis The Social Impact of AIDS in the United States by : National Research Council

Download or read book The Social Impact of AIDS in the United States written by National Research Council and published by National Academies Press. This book was released on 1993-02-01 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: Europe's "Black Death" contributed to the rise of nation states, mercantile economies, and even the Reformation. Will the AIDS epidemic have similar dramatic effects on the social and political landscape of the twenty-first century? This readable volume looks at the impact of AIDS since its emergence and suggests its effects in the next decade, when a million or more Americans will likely die of the disease. The Social Impact of AIDS in the United States addresses some of the most sensitive and controversial issues in the public debate over AIDS. This landmark book explores how AIDS has affected fundamental policies and practices in our major institutions, examining: How America's major religious organizations have dealt with sometimes conflicting values: the imperative of care for the sick versus traditional views of homosexuality and drug use. Hotly debated public health measures, such as HIV antibody testing and screening, tracing of sexual contacts, and quarantine. The potential risk of HIV infection to and from health care workers. How AIDS activists have brought about major change in the way new drugs are brought to the marketplace. The impact of AIDS on community-based organizations, from volunteers caring for individuals to the highly political ACT-UP organization. Coping with HIV infection in prisons. Two case studies shed light on HIV and the family relationship. One reports on some efforts to gain legal recognition for nonmarital relationships, and the other examines foster care programs for newborns with the HIV virus. A case study of New York City details how selected institutions interact to give what may be a picture of AIDS in the future. This clear and comprehensive presentation will be of interest to anyone concerned about AIDS and its impact on the country: health professionals, sociologists, psychologists, advocates for at-risk populations, and interested individuals.

Phase I Cancer Clinical Trials

Author : Elizabeth A. Eisenhauer
Publisher : Oxford University Press, USA
ISBN 13 : 0199359016
Total Pages : 369 pages
Book Rating : 4.1/5 (993 download)

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Book Synopsis Phase I Cancer Clinical Trials by : Elizabeth A. Eisenhauer

Download or read book Phase I Cancer Clinical Trials written by Elizabeth A. Eisenhauer and published by Oxford University Press, USA. This book was released on 2014-06 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. As this title is the only comprehensive book on this topic, it is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials.

A National Cancer Clinical Trials System for the 21st Century

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309157870
Total Pages : 317 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis A National Cancer Clinical Trials System for the 21st Century by : Institute of Medicine

Download or read book A National Cancer Clinical Trials System for the 21st Century written by Institute of Medicine and published by National Academies Press. This book was released on 2010-07-08 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.

Clinical Trials in Oncology, Third Edition

Author : Stephanie Green
Publisher : CRC Press
ISBN 13 : 1439814481
Total Pages : 266 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Clinical Trials in Oncology, Third Edition by : Stephanie Green

Download or read book Clinical Trials in Oncology, Third Edition written by Stephanie Green and published by CRC Press. This book was released on 2012-05-09 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.

Cancer Incidence and Survival Among Children and Adolescents

Author :
Publisher :
ISBN 13 :
Total Pages : 194 pages
Book Rating : 4.:/5 (327 download)

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Book Synopsis Cancer Incidence and Survival Among Children and Adolescents by :

Download or read book Cancer Incidence and Survival Among Children and Adolescents written by and published by . This book was released on 1999 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Beyond the HIPAA Privacy Rule

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309124999
Total Pages : 334 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine

Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Managing Cancer and Living Meaningfully

Author : Gary Rodin
Publisher : Oxford University Press
ISBN 13 : 0190236442
Total Pages : 265 pages
Book Rating : 4.1/5 (92 download)

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Book Synopsis Managing Cancer and Living Meaningfully by : Gary Rodin

Download or read book Managing Cancer and Living Meaningfully written by Gary Rodin and published by Oxford University Press. This book was released on 2021-04-27 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: Managing Cancer and Living Meaningfully provides valuable insight into the experience of patients and families living with advanced cancer and describes a novel psychotherapeutic approach to help them live meaningfully, while also facing the threat of mortality. Managing Cancer and Living Meaningfully, also known by the acronym CALM, is a brief supportive-expressive intervention that can be delivered by a wide range of trained healthcare providers as part of cancer care or early palliative care. The authors provide an overview of the clinical experience and research that led to the development of CALM, a clear description of the intervention, and a manualized guide to aid in its delivery. Situated in the context of early palliative care, this text is destined to be become essential reading for healthcare professionals engaged in providing psychological support to patients and their families who face the practical and profound problems of advanced disease.

The Health Effects of Cannabis and Cannabinoids

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309453070
Total Pages : 487 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis The Health Effects of Cannabis and Cannabinoids by : National Academies of Sciences, Engineering, and Medicine

Download or read book The Health Effects of Cannabis and Cannabinoids written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-03-31 with total page 487 pages. Available in PDF, EPUB and Kindle. Book excerpt: Significant changes have taken place in the policy landscape surrounding cannabis legalization, production, and use. During the past 20 years, 25 states and the District of Columbia have legalized cannabis and/or cannabidiol (a component of cannabis) for medical conditions or retail sales at the state level and 4 states have legalized both the medical and recreational use of cannabis. These landmark changes in policy have impacted cannabis use patterns and perceived levels of risk. However, despite this changing landscape, evidence regarding the short- and long-term health effects of cannabis use remains elusive. While a myriad of studies have examined cannabis use in all its various forms, often these research conclusions are not appropriately synthesized, translated for, or communicated to policy makers, health care providers, state health officials, or other stakeholders who have been charged with influencing and enacting policies, procedures, and laws related to cannabis use. Unlike other controlled substances such as alcohol or tobacco, no accepted standards for safe use or appropriate dose are available to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively. Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives, and this lack of aggregated knowledge has broad public health implications. The Health Effects of Cannabis and Cannabinoids provides a comprehensive review of scientific evidence related to the health effects and potential therapeutic benefits of cannabis. This report provides a research agendaâ€"outlining gaps in current knowledge and opportunities for providing additional insight into these issuesâ€"that summarizes and prioritizes pressing research needs.

Therapeutic Uses of Cannabis

Author : British Medical Association
Publisher : CRC Press
ISBN 13 : 1000159655
Total Pages : 160 pages
Book Rating : 4.0/5 (1 download)

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Book Synopsis Therapeutic Uses of Cannabis by : British Medical Association

Download or read book Therapeutic Uses of Cannabis written by British Medical Association and published by CRC Press. This book was released on 2020-08-17 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: At the last Annual Representative Meeting of the British Medical Association a motion was passed that `certain additional cannabinoids should be legalized for wider medicinal use.'' This report supports this landmark statement by reviewing the scientific evidence for the therapeutic use of cannabinoids and sets the agenda for change. It will be welcomed by those who believe that cannabinoids can be used in medical treatment. The report discusses in a clear and readable form the use and adverse effects of the drug for nausea, multiple sclerosis, pain, epilepsy, glaucoma, and asthma.

Diagnosing and Treating Adult Cancers and Associated Impairments

Author : National Academies Of Sciences Engineeri
Publisher : National Academies Press
ISBN 13 : 9780309684002
Total Pages : pages
Book Rating : 4.6/5 (84 download)

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Book Synopsis Diagnosing and Treating Adult Cancers and Associated Impairments by : National Academies Of Sciences Engineeri

Download or read book Diagnosing and Treating Adult Cancers and Associated Impairments written by National Academies Of Sciences Engineeri and published by National Academies Press. This book was released on 2021-11-10 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Cancer is the second leading cause of death among adults in the United States after heart disease. However, improvements in cancer treatment and earlier detection are leading to growing numbers of cancer survivors. As the number of cancer survivors grows, there is increased interest in how cancer and its treatments may affect a person's ability to work, whether the person has maintained employment throughout the treatment or is returning to work at a previous, current, or new place of employment. Cancer-related impairments and resulting functional limitations may or may not lead to disability as defined by the U.S. Social Security Administration (SSA), however, adults surviving cancer who are unable to work because of cancer-related impairments and functional limitations may apply for disability benefits from SSA. At the request of SSA, Diagnosing and Treating Adult Cancers and Associated Impairments provides background information on breast cancer, lung cancer, and selected other cancers to assist SSA in its review of the listing of impairments for disability assessments. This report addresses several specific topics, including determining the latest standards of care as well as new technologies for understanding disease processes, treatment modalities, and the effect of cancer on a person's health and functioning, in order to inform SSA's evaluation of disability claims for adults with cancer.

Methods and Impact of Controlled Therapeutic Trials in Cancer

Author : Natale Cascinelli
Publisher :
ISBN 13 : 9789290180593
Total Pages : 172 pages
Book Rating : 4.1/5 (85 download)

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Book Synopsis Methods and Impact of Controlled Therapeutic Trials in Cancer by : Natale Cascinelli

Download or read book Methods and Impact of Controlled Therapeutic Trials in Cancer written by Natale Cascinelli and published by . This book was released on 1978 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Clinical Judgment and Decision-making in Oncology

Author : Claude Lagarde (professeur.)
Publisher :
ISBN 13 :
Total Pages : 176 pages
Book Rating : 4.:/5 (311 download)

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Book Synopsis Clinical Judgment and Decision-making in Oncology by : Claude Lagarde (professeur.)

Download or read book Clinical Judgment and Decision-making in Oncology written by Claude Lagarde (professeur.) and published by . This book was released on 1981 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Randomization in Clinical Trials

Author : William F. Rosenberger
Publisher : John Wiley & Sons
ISBN 13 : 1118742249
Total Pages : 284 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Randomization in Clinical Trials by : William F. Rosenberger

Download or read book Randomization in Clinical Trials written by William F. Rosenberger and published by John Wiley & Sons. This book was released on 2015-11-23 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition “All medical statisticians involved in clinical trials should read this book...” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley.