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Author: Institute of Medicine
Publisher: National Academies Press
Published: 2011-04-03
Total Pages: 442
ISBN-13: 0309158060
DOWNLOAD EBOOKRare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author: Roger Walker (Ph. D.)
Publisher:
Published: 2003
Total Pages: 956
ISBN-13:
DOWNLOAD EBOOKThe new edition of this popular, well-established textbook addresses the expanding role of the pharmacist in treating patients. It covers treatment of common diseases as well as other medical, therapeutic and patient related issues. Written by both pharmacists and clinicians to reflect a team approach, it offers an in-depth analysis of drug therapy in the treatment of disease, relying on input from the pharmacist as a member of the "team" in hospital and community settings. Information is easy to locate in a logical format organized primarily by systems and disorders.
Author: National Research Council
Publisher: National Academies Press
Published: 2010-12-21
Total Pages: 163
ISBN-13: 030918651X
DOWNLOAD EBOOKRandomized 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.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2001-01-01
Total Pages: 221
ISBN-13: 0309171148
DOWNLOAD EBOOKClinical 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.
Author: Alfred Careño Croftan
Publisher:
Published: 1912
Total Pages: 754
ISBN-13:
DOWNLOAD EBOOKAuthor: Gerard A. McKay
Publisher: John Wiley & Sons
Published: 2021-01-26
Total Pages: 313
ISBN-13: 1119599954
DOWNLOAD EBOOKA must-have companion for medical students and junior doctors for almost four decades, Lecture Notes: Clinical Pharmacology and Therapeutics provides concise yet thorough coverage of the principles of clinical pharmacology, the major characteristics of therapeutics, and the practical aspects of prescribing drugs to alleviate symptoms and to treat disease. Whether you are preparing for examinations or prescribing to patients, the tenth edition offers readers current and authoritative insight into the essential practical and clinical knowledge. Logically organised chapters allow for rapid location of key information, while examples of commonly encountered scenarios illustrate how and when to use drugs in clinical situations. Throughout the text, practice questions, prescribing guidelines, and self-assessment tests clarify and reinforce the principles that inform appropriate clinical decision-making. Presents an up-to-date review of drug use across all major clinical disciplines Offers a timely overview of clinical drug trials and development Provides new clinical scenarios to relate chapter content to real-life application Contains colour-coded "Key Points" and "Prescribing Points" to highlight important information Includes chapter introductions and summaries, and numerous figures, tables, and colour illustrations Lecture Notes: Clinical Pharmacology and Therapeutics, Tenth Edition, is an essential resource for medical students, junior doctors, and other prescribers looking for an up-to-date reference on pharmacological principles, prescribing, and therapeutics.
Author: Shivaani Kummar
Publisher: Academic Press
Published: 2018-05-26
Total Pages: 0
ISBN-13: 9780128125120
DOWNLOAD EBOOKNovel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials.
Author: Derek G. Waller
Publisher: Elsevier Health Sciences
Published: 2013-08-07
Total Pages: 741
ISBN-13: 0702055034
DOWNLOAD EBOOKThis book covers all the pharmacology you need, from basic science pharmacology and pathophysiology, through to clinical pharmacology to therapeutics, in line with the integrated approach of new medical curricula. The first section covers the basic principles, and the rest is organised by body systems. The book ends with sections on toxicity and prescribing practice. Integrates basic science pharmacology, clinical pharmacology and therapeutics Brief review of pathophysiology of major diseases Case histories and multiple choice questions (and answers) Tabular presentation of all common drugs within each class Section on further reading Kinetics chapter simplified with more practical examples Includes more on genetic issues Drug tables made more concise to make information more accessible Fully updated to reflect current clinical practice
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2015-04-20
Total Pages: 236
ISBN-13: 0309316324
DOWNLOAD EBOOKData 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.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Published: 2020-08-27
Total Pages: 127
ISBN-13: 0309672988
DOWNLOAD EBOOKRecognizing the potential design complexities and ethical issues associated with clinical trials for gene therapies, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop in Washington, DC, on November 13, 2019. Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients. The workshop also included discussions of topics related to gene therapies in the context of other available and potentially curative treatments, such as bone marrow transplantation for hemoglobinopathies. This publication summarizes the presentation and discussion of the workshop.
