The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials PDF

Author: National Research Council

Publisher: National Academies Press

Published: 2010-12-21

Total Pages: 163

ISBN-13: 030918651X

DOWNLOAD EBOOK →

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.

NIH Data Book

NIH Data Book PDF

Author:

Publisher:

Published: 1982

Total Pages: 132

ISBN-13:

DOWNLOAD EBOOK →

A source for financial information on NIH programs and related federal and national activities. Contains data on health R&D costs, NIH appropriations and obligations, extramural awards, research training, NIH staff and clinical center, and national mortality and morbidity data.

Sharing Clinical Trial Data

Sharing Clinical Trial Data PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-04-20

Total Pages: 236

ISBN-13: 0309316324

DOWNLOAD EBOOK →

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.

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes PDF

Author: Agency for Healthcare Research and Quality/AHRQ

Publisher: Government Printing Office

Published: 2014-04-01

Total Pages: 396

ISBN-13: 1587634333

DOWNLOAD EBOOK →

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. 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.

Guide to Effective Grant Writing

Guide to Effective Grant Writing PDF

Author: Otto O. Yang

Publisher: Springer Science & Business Media

Published: 2007-02-16

Total Pages: 96

ISBN-13: 0387277498

DOWNLOAD EBOOK →

Guide to Effective Grant Writing: How to Write a Successful NIH Grant is written to help the 100,000+ post-graduate students and professionals who need to write effective proposals for grants. There is little or no formal teaching about the process of writing grants for NIH, and many grant applications are rejected due to poor writing and weak formulation of ideas. Procuring grant funding is the central key to survival for any academic researcher in the biological sciences; thus, being able to write a proposal that effectively illustrates one's ideas is essential. Covering all aspects of the proposal process, from the most basic questions about form and style to the task of seeking funding, this volume offers clear advice backed up with excellent examples. Included are a number of specimen proposals to help shed light on the important issues surrounding the writing of proposals. The Guide is a clear, straight-forward, and reader-friendly tool. Guide to Effective Grant Writing: How to Write a Successful NIH Grant Writing is based on Dr. Yang's extensive experience serving on NIH grant review panels; it covers the common mistakes and problems he routinely witnesses while reviewing grants.

Lanterna Rally - Theme by Grace Themes