Analysing Survival Data From Clinical Trials And Observational Studies PDF Download
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| Author | : Ettore Marubini |
| Publisher | : John Wiley & Sons |
| Total Pages | : 435 |
| Release | : 2004-07-02 |
| Genre | : Mathematics |
| ISBN | : 0470093412 |
Download Analysing Survival Data from Clinical Trials and Observational Studies Book in PDF, ePub and Kindle
A practical guide to methods of survival analysis for medical researchers with limited statistical experience. Methods and techniques described range from descriptive and exploratory analysis to multivariate regression methods. Uses illustrative data from actual clinical trials and observational studies to describe methods of analysing and reporting results. Also reviews the features and performance of statistical software available for applying the methods of analysis discussed.
| Author | : Ettore Marubini |
| Publisher | : John Wiley & Sons |
| Total Pages | : 436 |
| Release | : 2004-07-02 |
| Genre | : Mathematics |
| ISBN | : 9780470093412 |
Download Analysing Survival Data from Clinical Trials and Observational Studies Book in PDF, ePub and Kindle
A practical guide to methods of survival analysis for medical researchers with limited statistical experience. Methods and techniques described range from descriptive and exploratory analysis to multivariate regression methods. Uses illustrative data from actual clinical trials and observational studies to describe methods of analysing and reporting results. Also reviews the features and performance of statistical software available for applying the methods of analysis discussed.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 221 |
| Release | : 2001-01-01 |
| Genre | : Medical |
| ISBN | : 0309171148 |
Download Small Clinical Trials Book in PDF, ePub and Kindle
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.
| Author | : Agency for Health Care Research and Quality (U.S.) |
| Publisher | : Government Printing Office |
| Total Pages | : 236 |
| Release | : 2013-02-21 |
| Genre | : Medical |
| ISBN | : 1587634236 |
Download Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide Book in PDF, ePub and Kindle
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)
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 236 |
| Release | : 2015-04-20 |
| Genre | : Medical |
| ISBN | : 0309316324 |
Download Sharing Clinical Trial Data Book in PDF, ePub and Kindle
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.
| Author | : David Collett |
| Publisher | : CRC Press |
| Total Pages | : 413 |
| Release | : 2003-03-28 |
| Genre | : Mathematics |
| ISBN | : 1584883251 |
Download Modelling Survival Data in Medical Research, Second Edition Book in PDF, ePub and Kindle
Critically acclaimed and resoundingly popular in its first edition, Modelling Survival Data in Medical Research has been thoroughly revised and updated to reflect the many developments and advances--particularly in software--made in the field over the last 10 years. Now, more than ever, it provides an outstanding text for upper-level and graduate courses in survival analysis, biostatistics, and time-to-event analysis.The treatment begins with an introduction to survival analysis and a description of four studies that lead to survival data. Subsequent chapters then use those data sets and others to illustrate the various analytical techniques applicable to such data, including the Cox regression model, the Weibull proportional hazards model, and others. This edition features a more detailed treatment of topics such as parametric models, accelerated failure time models, and analysis of interval-censored data. The author also focuses the software section on the use of SAS, summarising the methods used by the software to generate its output and examining that output in detail. Profusely illustrated with examples and written in the author's trademark, easy-to-follow style, Modelling Survival Data in Medical Research, Second Edition is a thorough, practical guide to survival analysis that reflects current statistical practices.
| Author | : National Research Council |
| Publisher | : National Academies Press |
| Total Pages | : 163 |
| Release | : 2010-12-21 |
| Genre | : Medical |
| ISBN | : 030918651X |
Download The Prevention and Treatment of Missing Data in Clinical Trials Book in PDF, ePub and Kindle
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.
| Author | : David Collett |
| Publisher | : CRC Press |
| Total Pages | : 538 |
| Release | : 2015-05-04 |
| Genre | : Mathematics |
| ISBN | : 1498731694 |
Download Modelling Survival Data in Medical Research Book in PDF, ePub and Kindle
Modelling Survival Data in Medical Research describes the modelling approach to the analysis of survival data using a wide range of examples from biomedical research.Well known for its nontechnical style, this third edition contains new chapters on frailty models and their applications, competing risks, non-proportional hazards, and dependent censo
| Author | : Peter F. Thall |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 263 |
| Release | : 2012-12-06 |
| Genre | : Medical |
| ISBN | : 1461520096 |
Download Recent Advances in Clinical Trial Design and Analysis Book in PDF, ePub and Kindle
Clinical trials have two purposes -- to treat the patients in the trial, and to obtain information which increases our understanding of the disease and especially how patients respond to treatment. Statistical design provides a means to achieve both these aims, while statistical data analysis provides methods for extracting useful information from the trial data. Recent advances in statistical computing have enabled statisticians to implement very rapidly a broad array of methods which previously were either impractical or impossible. Biostatisticians are now able to provide much greater support to medical researchers working in both clinical and laboratory settings. As our collective toolkit of techniques for analyzing data has grown, it has become increasingly difficult for biostatisticians to keep up with all the developments in our own field. Recent Advances in Clinical Trial Design and Analysis brings together biostatisticians doing cutting-edge research and explains some of the more recent developments in biostatistics to clinicians and scientists who work in clinical trials.
| Author | : David Machin |
| Publisher | : John Wiley & Sons |
| Total Pages | : 278 |
| Release | : 2006-03-30 |
| Genre | : Medical |
| ISBN | : 0470870419 |
Download Survival Analysis Book in PDF, ePub and Kindle
Well received in its first edition, Survival Analysis: A Practical Approach is completely revised to provide an accessible and practical guide to survival analysis techniques in diverse environments. Illustrated with many authentic examples, the book introduces basic statistical concepts and methods to construct survival curves, later developing them to encompass more specialised and complex models. During the years since the first edition there have been several new topics that have come to the fore and many new applications. Parallel developments in computer software programmes, used to implement these methodologies, are relied upon throughout the text to bring it up to date.
