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.

Registries for Evaluating Patient Outcomes
Registries for Evaluating Patient Outcomes

Author: Agency for Healthcare Research and Quality/AHRQ

Publisher: Government Printing Office

Published: 2014-04-01

Total Pages: 385

ISBN-13: 1587634333

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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.

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.

Handbook of Economic Evaluation of HIV Prevention Programs
Handbook of Economic Evaluation of HIV Prevention Programs

Author: David R. Holtgrave

Publisher: Springer Science & Business Media

Published: 2013-06-29

Total Pages: 291

ISBN-13: 1489918787

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If resources for HIV prevention efforts were truly unlimited, then this book would be en tirely unnecessary. In a world with limitless support for HIV prevention activities, one would simply implement all effective (or potentially effective) programs without regard to expense. We would do everything useful to prevent the further spread of the virus that has already claimed hundreds of thousands of lives in the United States and millions of lives worldwide. Unfortunately, funding for HIV prevention programs is limited. Even though the amount of available funding may seem quite large (especially in the United States), it is still fixed and not sufficient to meet all needs for such programs. This was very well illustrated in the summer of 1997 when over 500 community-based organizations applied for a combined total of $18 million of HIV prevention funding from the U.S. Centers for Disease Control and Prevention (CDC). Less than one-fifth ofthese organizations received support via this funding mechanism. Hence, although $18 million may seem like a large amount of money at first blush, it is not enough to meet all of the prevention needs that could be addressed by these community-based organizations.

HIV Prevention
HIV Prevention

Author: Kenneth H. Mayer

Publisher: Academic Press

Published: 2009-03-13

Total Pages: 692

ISBN-13: 0080921299

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HIV/AIDS continues to be the pandemic of our times and there has not been a comprehensive medically based AIDS prevention book published in the last 5 years. It is estimated that 36 to 45 million people including 2-3 million children already are infected worldwide and an additional 4-7 million more are infected each year. There are about 6,000 new infections daily and about 12 million AIDS orphans. People receiving AIDS treatments feel well and have no detectable viral load, but still can infect others. And even when a vaccine is found, it will take many years before it can be administered across the developing world. - Discusses all aspects of AIDS prevention, from epidemiology, molecular immunology and virology to the principles of broad-based public health prevention interventions - Special focus on the array of interventions that have been proven effective through rigorous study - Identifies new trends in HIV/AID epidemiology and their impact on creating and implementing prevention interventions - Incorporates virology, biology, infectious diseases, vaccinology, microbicides and research methodologies into AIDS prevention

Non-pricing Methods to Optimize High Occupancy Vehicle Lane Usage
Non-pricing Methods to Optimize High Occupancy Vehicle Lane Usage

Author: George E. Gray

Publisher:

Published: 2001

Total Pages: 82

ISBN-13:

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This study examines the feasibility of broadening the pool of high occupancy vehicle (HOV) users on a no-cost basis for HOV facilities where such inclusion would not lead to capacity problems. Focus is on identifying various potential non-pricing methods for optimizing the use of HOV facilities. A large number of various potential non- pricing user groups are identified, evaluated, and consolidated by using these attributes: air quality, fuel savings, enforcement safety, system efficiency, cost effectiveness, and capacity that is treated as a potential fatal flaw.

Ten Steps to a Results-based Monitoring and Evaluation System
Ten Steps to a Results-based Monitoring and Evaluation System

Author: Jody Zall Kusek

Publisher: World Bank Publications

Published: 2004-06-15

Total Pages: 270

ISBN-13: 0821382896

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An effective state is essential to achieving socio-economic and sustainable development. With the advent of globalization, there are growing pressures on governments and organizations around the world to be more responsive to the demands of internal and external stakeholders for good governance, accountability and transparency, greater development effectiveness, and delivery of tangible results. Governments, parliaments, citizens, the private sector, NGOs, civil society, international organizations and donors are among the stakeholders interested in better performance. As demands for greater accountability and real results have increased, there is an attendant need for enhanced results-based monitoring and evaluation of policies, programs, and projects. This Handbook provides a comprehensive ten-step model that will help guide development practitioners through the process of designing and building a results-based monitoring and evaluation system. These steps begin with a OC Readiness AssessmentOCO and take the practitioner through the design, management, and importantly, the sustainability of such systems. The Handbook describes each step in detail, the tasks needed to complete each one, and the tools available to help along the way."