Tag Archives: clinical research

Sharing Clinical Trial Data to Advance Scientific Discovery and Improve Care

Clinical trials generate vast amounts of data, yet a large portion of this information is never published or made available to other researchers. Data sharing could advance scientific discovery and improve clinical care, but it involves potential risks and costs for key stakeholders, including clinical trialists, sponsors, researchers, and patients. Our publications discuss the challenges and opportunities for stakeholders to better harmonize incentives, policy, data standards, and governance to encourage the sharing and reuse of clinical trial data sharing.

Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk

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 …

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The Prevention and Treatment of Missing Data in Clinical Trials

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 …

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Sharing Clinical Research Data: Workshop Summary

Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely …

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Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine

Every patient is unique, and the evolving field of precision medicine aims to ensure the delivery of the right treatment to the right patient at the right time. In an era of rapid advances in biomedicine and enhanced understanding of the genetic …

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Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities

Sharing data generated through the conduct of clinical trials offers the promise of placing evidence about the safety and efficacy of therapies and clinical interventions on a firmer basis and enhancing the benefits of clinical trials. …

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A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program

The National Cancer Institute’s (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim …

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Ovarian Cancers: Evolving Paradigms in Research and Care

In an era of promising advances in cancer research, there are considerable and even alarming gaps in the fundamental knowledge and understanding of ovarian cancer. Researchers now know that ovarian cancer is not a single disease–several distinct …

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Exploring Vaccination Safety

As vaccine research and development continues to grow, so does the debate regarding vaccination safety and best practices. Our reports review the clinical and biological evidence regarding immunization safety.

The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies

Vaccines are among the most safe and effective public health interventions to prevent serious disease and death. Because of the success of vaccines, most Americans today have no firsthand experience with such devastating illnesses as polio or …

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Adverse Effects of Vaccines: Evidence and Causality

In 1900, for every 1,000 babies born in the United States, 100 would die before their first birthday, often due to infectious diseases. Today, vaccines exist for many viral and bacterial diseases. The National Childhood Vaccine Injury Act, passed …

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Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop

During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs) (e.g., drugs, vaccines, devices) may need to be dispensed or administered to …

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Integrating Clinical Research into Epidemic Response: The Ebola Experience

The 2014–2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two …

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Eliminating the Public Health Problem of Hepatitis B and C in the United States: Phase One Report

Hepatitis B and C cause most cases of hepatitis in the United States and the world. The two diseases account for about a million deaths a year and 78 percent of world’s hepatocellular carcinoma and more than half of all fatal cirrhosis. In 2013 …

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Priorities for the National Vaccine Plan

Vaccination is a fundamental component of preventive medicine and public health. The use of vaccines to prevent infectious diseases has resulted in dramatic decreases in disease, disability, and death in the United States and around the world. …

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Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint

As a number of diseases emerge or reemerge thus stimulating new vaccine development opportunities to help prevent those diseases, it can be especially difficult for decision makers to know where to invest their limited resources. Therefore, it is …

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Ranking Vaccines: A Prioritization Software Tool: Phase II: Prototype of a Decision-Support System

SMART Vaccines–Strategic Multi-Attribute Ranking Tool for Vaccines–is a prioritization software tool developed by the Institute of Medicine that utilizes decision science and modeling to help inform choices among candidates for new vaccine …

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Ranking Vaccines: Applications of a Prioritization Software Tool: Phase III: Use Case Studies and Data Framework

SMART Vaccines – Strategic Multi-Attribute Ranking Tool for Vaccines – is a prioritization software tool developed by the Institute of Medicine that utilizes decision science and modeling to help inform choices among candidates for new vaccine …

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FREE FROM NAP: December 2010

Examination of Front-of-Package Nutrition Rating Systems and Symbols Examination of Front-of-Package Nutrition Rating Systems and Symbols: Phase I Report

The federal government requires that most packaged foods carry a standardized label–the Nutrition Facts panel–that provides nutrition information intended to help consumers make healthful choices. In recent years, manufacturers have begun to include…
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The Power of Renewables The Power of Renewables: Opportunities and Challenges for China and the United States

The United States and China are the world’s top two energy consumers and, as of 2010, the two largest economies. Consequently, they have a decisive role to play in the world’s clean energy future. Both countries are also motivated by related goals, namely…
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High School Dropout, Graduation, and Completion Rates High School Dropout, Graduation, and Completion Rates: Better Data, Better Measures, Better Decisions

High school graduation and dropout rates have long been used as indicators of educational system productivity and effectiveness and of social and economic well being. While determining these rates may seem like a straightforward task, their calculation is in…
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The Role of Human Factors in Home Health Care The Role of Human Factors in Home Health Care: Workshop Summary

The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be…
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Strengthening the National Institute of Justice Strengthening the National Institute of Justice

The National Institute of Justice (NIJ) is the nation’s primary resource for advancing scientific research, development, and evaluation on crime and crime control and the administration of justice in the United States. Headed by a presidentially appointed…
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The 2009 H1N1 Influenza Vaccination Campaign The 2009 H1N1 Influenza Vaccination Campaign: Summary of a Workshop Series

The 2009 H1N1 vaccination campaign was one of the largest public health campaigns in U.S. history, vaccinating one-quarter of the population in the first three months. The IOM held three workshops in Raleigh, NC; Austin, TX; and Seattle, WA to learn from…
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When Weather Matters When Weather Matters: Science and Service to Meet Critical Societal Needs

The past 15 years have seen marked progress in observing, understanding, and predicting weather. At the same time, the United States has failed to match or surpass progress in operational numerical weather prediction achieved by other nations and failed to…
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Research Priorities for Assessing Health Effects from the Gulf of Mexico Oil Spill Research Priorities for Assessing Health Effects from the Gulf of Mexico Oil Spill: A Letter Report

It is as yet uncertain how the Gulf of Mexico oil spill will affect the health of clean-up workers and volunteers, residents, and visitors in the Gulf. The IOM recommends that the U.S. Department of Health and Human Services focus on researching psychological…
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Transforming Clinical Research in the United States Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary

An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and…
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Critical Code Critical Code: Software Producibility for Defense

Critical Code contemplates Department of Defense (DoD) needs and priorities for software research and suggests a research agenda and related actions. Building on two prior books–Summary of a Workshop on Software Intensive Systems and…
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