Science, Medicine, and Animals
Science, Medicine, and Animals

Author: National Research Council

Publisher: National Academies Press

Published: 2006-02-19

Total Pages: 23

ISBN-13: 0309101174

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Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.

Small Clinical Trials
Small Clinical Trials

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2001-01-01

Total Pages: 221

ISBN-13: 0309171148

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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
The Prevention and Treatment of Missing Data in Clinical Trials

Author: National Research Council

Publisher: National Academies Press

Published: 2010-12-21

Total Pages: 163

ISBN-13: 030918651X

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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.

Evolution of Translational Omics
Evolution of Translational Omics

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-09-13

Total Pages: 354

ISBN-13: 0309224187

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Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

Sharing Clinical Trial Data
Sharing Clinical Trial Data

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-04-20

Total Pages: 236

ISBN-13: 0309316324

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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.

The Official ACT Prep Guide, 2018
The Official ACT Prep Guide, 2018

Author: ACT

Publisher: John Wiley & Sons

Published: 2017-06-09

Total Pages: 724

ISBN-13: 1119398843

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The only guide from the ACT organization, the makers of the exam, revised and updated for 2017 and beyond The Official ACT Prep Guide, 2018 Edition, Revised and Updated is the must-have resource for college bound students. The guide is the go-to handbook for ACT preparation and the only guide from the makers of the exam. The book and online content includes the actual ACT test forms (taken from real ACT exams). In addition, this comprehensive resource has everything students need to know about when they are preparing for and taking the ACT. The book contains information on how to register for the exam, proven test-taking strategies, ideas for preparing mentally and physically, gearing up for test day, and much more. This invaluable guide includes additional questions and material that contains articles on everything from preparing a standout college application and getting into your top-choice school to succeeding in college The bestselling prep guide from the makers of the ACT test Offers bonus online content to help boost college readiness Contains the real ACT test forms used in previous years This new edition offers students updated data on scoring your writing test, new reporting categories, as well as updated tips on how to do your best preparing for the test and on the actual test day from the team at ACT. It also offers additional 400 practice questions that are available online.

After 50 Years of Ministry
After 50 Years of Ministry

Author: Bob Russell

Publisher: Moody Publishers

Published: 2016-05-13

Total Pages: 245

ISBN-13: 0802493718

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“If I had my entire life to live over, I’d choose to be a preacher again. It’s been extremely rewarding and gratifying. But I could do ministry a lot better if given a second try. As I look back on my forty years at Southeast Christian Church in Louisville, KY, I wish I had a mulligan. This book lists seven things I’d do differently and seven I’d do about the same. They are written in hopes they’ll be a source of encouragement for those growing weary and losing heart. I pray my observations will inspire others to conclude, ‘If he can do it, I can, too.’ In this book I share both the joys and sorrows of my ministry, both the successes and failures. I’m going to be as transparent as possible in hopes that it will encourage ministers to stand firm in the faith and be faithful unto death. If just one minister is motivated to pick up the sword of the Spirit and re-enter the battle, it will be well worth the effort.” — Bob Russell

Group Sequential Methods with Applications to Clinical Trials
Group Sequential Methods with Applications to Clinical Trials

Author: Christopher Jennison

Publisher: CRC Press

Published: 1999-09-15

Total Pages: 416

ISBN-13: 9781584888581

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Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion. Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.

In the Name of Science
In the Name of Science

Author: F. Barbara Orlans

Publisher: Oxford University Press

Published: 1993-07-08

Total Pages: 312

ISBN-13: 0199762805

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Few arguments in biomedical experimentation have stirred such heated debate in recent years as those raised by animal research. In this comprehensive analysis of the social, political, and ethical conflicts surrounding the use of animals in scientific experiments, Barbara Orlans judges both ends of the spectrum in this debate -- unconditional approval or rejection of animal experimentation -- to be untenable. Instead of arguing for either view, she thoughtfully explores the ground between the extremes, and convincingly makes the case for public policy reforms that serve to improve the welfare of laboratory animals without jeopardizing scientific endeavor. This book presents controversial issues in a balanced manner based on careful historical analysis and original research. Different mechanisms of oversight for animal experiments are compared and those that have worked well are identified. This compelling work will be of interest to biomedical scientists, ethicists, animal welfare advocates and other readers concerned with this critical issue.