@BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Kirsten Bibbins-Domingo and Alex Helman", title = "Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups", isbn = "978-0-309-27820-1", abstract = "The United States has long made substantial investments in clinical research with the goal of improving the health and well-being of our nation. There is no doubt that these investments have contributed significantly to treating and preventing disease and extending human life. Nevertheless, clinical research faces a critical shortcoming. Currently, large swaths of the U.S. population, and those that often face the greatest health challenges, are less able to benefit from these discoveries because they are not adequately represented in clinical research studies. While progress has been made with representation of white women in clinical trials and clinical research, there has been little progress in the last three decades to increase participation of racial and ethnic minority population groups. This underrepresentation is compounding health disparities, with serious consequences for underrepresented groups and for the nation.\nAt the request of Congress, Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups identifies policies, procedures, programs, or projects aimed at increasing the inclusion of these groups in clinical research and the specific strategies used by those conducting clinical trials and clinical and translational research to improve diversity and inclusion. This report models the potential economic benefits of full inclusion of men, women, and racial and ethnic groups in clinical research and highlights new programs and interventions in medical centers and other clinical settings designed to increase participation.", url = "https://nap.nationalacademies.org/catalog/26479/improving-representation-in-clinical-trials-and-research-building-research-equity", year = 2022, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Theresa Wizemann and Amanda Wagner Gee and Carolyn Shore", title = "Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop", isbn = "978-0-309-26928-5", abstract = "The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands.\nLooking ahead to 2030, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine convened a public workshop for stakeholders from across the drug research and development life cycle to reflect on the lessons learned over the past 10 years and consider opportunities for the future. The workshop was designed to consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system so that outcomes and experiences for all stakeholders are improved. This Proceedings of a Workshop summarizes the presentations and discussions that took place during the four-part virtual public workshop held on January 26, February 9, March 24, and May 11, 2021.", url = "https://nap.nationalacademies.org/catalog/26349/envisioning-a-transformed-clinical-trials-enterprise-for-2030-proceedings-of", year = 2022, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Theresa Wizemann and Andrew March and Carolyn Shore", title = "Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop", isbn = "978-0-309-69637-1", abstract = "Approximately 4 million pregnant people in the United States give birth annually, and 70 percent of these individuals take at least one prescription medication during their pregnancy. Yet, due to a number of historical, ethical, legal, scientific, and societal issues, pregnant and lactating persons are often excluded from clinical trials. As a result, pregnant and lactating persons are often taking drugs based on limited information about the benefits and risks to themselves and their developing or newborn baby.\nThe National Academies Forum on Drug Discovery, Development, and Translation convened a workshop in June 2022 for stakeholders to examine the current state of evidence generation for drug products used by pregnant and lactating persons and discuss barriers and opportunities for including these populations in clinical trials. This publication summarizes the presentations and discussion of the workshop.", url = "https://nap.nationalacademies.org/catalog/26790/inclusion-of-pregnant-and-lactating-persons-in-clinical-trials-proceedings", year = 2023, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Sheena M. Posey Norris and Lisa Bain and Clare Stroud", title = "Neuroscience Trials of the Future: Proceedings of a Workshop", isbn = "978-0-309-44255-8", abstract = "On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine\u2019s Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.", url = "https://nap.nationalacademies.org/catalog/23502/neuroscience-trials-of-the-future-proceedings-of-a-workshop", year = 2016, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Joe Alper and Eeshan Khandekar and Carolyn Shore", title = "Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop", isbn = "978-0-309-49488-5", abstract = "Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. \n\nOn November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/25502/virtual-clinical-trials-challenges-and-opportunities-proceedings-of-a-workshop", year = 2019, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Victoria Weisfeld and Rebecca A. English and Anne B. Claiborne", title = "Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary", isbn = "978-0-309-21929-7", abstract = "Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.", url = "https://nap.nationalacademies.org/catalog/13237/public-engagement-and-clinical-trials-new-models-and-disruptive-technologies", year = 2012, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Sharyl J. Nass and Margie Patlak", title = "Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary", isbn = "978-0-309-28724-1", abstract = "The National Clinical Trials Network (NCTN) supported by the National Cancer Institute (NCI) has played an integral role in cancer research and in establishing the standard of care for cancer patients for more than 50 years. Formerly known as the NCI Clinical Trials Cooperative Group Program, the NCTN is comprised of more than 2,100 institutions and 14,000 investigators, who enroll more than 20,000 cancer patients in clinical trials each year across the United States and internationally.\n \nRecognizing the recent transformative advances in cancer research that necessitate modernization in how cancer clinical trials are run, as well as inefficiencies and other challenges impeding the national cancer clinical trials program, the NCI asked the IOM to develop a set of recommendations to improve the federally funded cancer clinical trials system. These recommendations were published in the 2010 report, A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. \n \nIn early 2011, the NCPF and the American Society of Clinical Oncology (ASCO) held a workshop in which stakeholders discussed the changes they planned to implement in response to the IOM goals and recommendations. Two years later, on February 11-12, 2013, in Washington, DC, the NCPF and ASCO reconvened stakeholders to report on the changes they have made thus far to address the IOM recommendations. At this workshop, representatives from the NCI, the NCTN, comprehensive cancer centers, patient advocacy groups, the Food and Drug Administration (FDA), industry, and other stakeholders highlighted the progress that has been made in achieving the goals for a reinvigorated national cancer clinical trials system. Implementing a National Cancer Clinical Trials System for the 21st Century is a summary of that workshop. \n ", url = "https://nap.nationalacademies.org/catalog/18362/implementing-a-national-cancer-clinical-trials-system-for-the-21st-century", year = 2013, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Alison Mack and Sharyl J. Nass", title = "Implementing a National Cancer Clinical Trials System for the 21st Century: Workshop Summary", isbn = "978-0-309-21268-7", abstract = "Clinical trials enable scientific discoveries to advance patient care, in addition to informing and guiding subsequent research. The National Cancer Institute's (NCI's) Clinical Trials Cooperative Group Program works to advance patient care and research. The Cooperative Group Program has been instrumental in establishing the standards for cancer patient care and clinical research methods. Despite broad participation in the program, financial strain and procedural burdens limit the ability of the Cooperative Group Program to undertake medical practice-changing clinical research.\nThus, the Institute of Medicine's (IOM's) National Cancer Policy Forum and the American Society of Clinical Oncology held a workshop on March 21, 2011 to follow up on the 2010 IOM report, A National Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, which made recommendations to strengthen the NCI Cooperative Group Program. In keeping with the established commitment to excellence Implementing a National Cancer Clinical Trials System for the 21st Century outlines how to improve the current system by incorporating innovative science and trial design into cancer clinical trials. It also examines the impact of increasing quality in regards to speed, efficiency, design, launch, and conduct, as well as improving prioritization, and incentivized participation.", url = "https://nap.nationalacademies.org/catalog/13154/implementing-a-national-cancer-clinical-trials-system-for-the-21st-century", year = 2011, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Claudia Grossmann and Julia Sanders and Rebecca A. English", title = "Large Simple Trials and Knowledge Generation in a Learning Health System: Workshop Summary", isbn = "978-0-309-28911-5", abstract = "Randomized clinical trials (RCTs) are often referred to as the \"gold standard\" of clinical research. However, in its current state, the U.S. clinical trials enterprise faces substantial challenges to the efficient and effective conduct of research. Streamlined approaches to RCTs, such as large simple trials (LSTs), may provide opportunities for progress on these challenges. Clinical trials support the development of new medical products and the evaluation of existing products by generating knowledge about safety and efficacy in pre- and post-marketing settings and serve to inform medical decision making and medical product development. Although well-designed and -implemented clinical trials can provide robust evidence, a gap exists between the evidence needs of a continuously learning health system, in which all medical decisions are based on the best available evidence, and the reality, in which the generation of timely and practical evidence faces significant barriers.\nLarge Simple Trials and Knowledge Generation in a Learning Health System is the summary of a workshop convened by the Institute of Medicine's Roundtable on Value & Science-Driven Health Care and the Forum on Drug Discovery, Development, and Translation. Experts from a wide range of disciplines--including health information technology, research funding, clinical research methods, statistics, patients, product development, medical product regulation, and clinical outcomes research--met to marshal a better understanding of the issues, options, and approaches to accelerating the use of LSTs. This publication summarizes discussions on the potential of LSTs to improve the speed and practicality of knowledge generation for medical decision making and medical product development, including efficacy and effectiveness assessments, in a continuously learning health system.\nLarge Simple Trials and Knowledge Generation in a Learning Health System explores acceleration of the use of LSTs to improve the speed and practicality of knowledge generation for medical decision making and medical product development; considers the concepts of LST design, examples of successful LSTs, the relative advantages of LSTs, and the infrastructure needed to build LST capacity as a routine function of care; identifies structural, cultural, and regulatory barriers hindering the development of an enhanced LST capacity; discusses needs and strategies in building public demand for and participation in LSTs; and considers near-term strategies for accelerating progress in the uptake of LSTs in the United States.", url = "https://nap.nationalacademies.org/catalog/18400/large-simple-trials-and-knowledge-generation-in-a-learning-health-system", year = 2013, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Henry J. Aaron and Hellen Gelband", title = "Extending Medicare Reimbursement in Clinical Trials", isbn = "978-0-309-06888-8", abstract = "Increasingly over the past five years, uncertainty about reimbursement for routine patient care has been suspected as contributing to problems enrolling people in clinical trials. Clinical trial investigators cannot guarantee that Medicare will pay for the care required, and they must disclose this uncertainty to potential participants during the informed consent process. Since Medicare does not routinely \"preauthorize\" care (as do many commercial insurers) the uncertainty cannot be dispelled in advance. Thus, patients considering whether to enter trials must assume that they may have to pay bills that Medicare rejects simply because they have enrolled in the trial.\nThis report recommends an explicit policy for reimbursement of routine patient care costs in clinical trials. It further recommends that HCFA provide additional support for selected clinical trials, and that the government support the establishment of a national clinical trials registry. These policies (1) should assure that beneficiaries would not be denied coverage merely because they have volunteered to participate in a clinical trial; and (2) would not impose excessive administrative burdens on HCFA, its fiscal intermediaries and carriers, or investigators, providers, or participants in clinical trials. Explicit rules would have the added benefit of increasing the uniformity of reimbursement decisions made by Medicare fiscal intermediaries and carriers in different parts of the country. Greater uniformity would, in turn, decrease the uncertainty about reimbursement when providers and patients embark on a clinical trial.", url = "https://nap.nationalacademies.org/catalog/9742/extending-medicare-reimbursement-in-clinical-trials", year = 2000, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Karen M. Anderson and Steve Olson", title = "Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials: Proceedings of a Workshop", isbn = "978-0-309-44357-9", abstract = "Even as the U.S. population becomes steadily more diverse, minorities and women remain underrepresented in clinical trials to develop new drugs and medical devices. Although progress in increasing minority participation in clinical trials has occurred, participation rates do not fully represent the overall population of minorities in the United States. This underrepresentation threatens the health of both these populations and the general population, since greater minority representation could reveal factors that affect health in all populations. Federal legislation has sought to increase the representation of minorities and women in clinical trials, but legislation by itself has not been sufficient to overcome the many barriers to greater participation. Only much broader changes will bring about the meaningful participation of all population groups in the clinical research needed to improve health. To examine the barriers to participation in clinical trials and ways of overcoming those barriers, the National Academies of Sciences, Engineering, and Medicine held a workshop in April 2015. This publication summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/23530/strategies-for-ensuring-diversity-inclusion-and-meaningful-participation-in-clinical-trials", year = 2016, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Charles H. Evans, Jr. and Suzanne T. Ildstad", title = "Small Clinical Trials: Issues and Challenges", isbn = "978-0-309-07333-2", abstract = "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.\nSmall 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.", url = "https://nap.nationalacademies.org/catalog/10078/small-clinical-trials-issues-and-challenges", year = 2001, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Neil Weisfeld and Rebecca A. English and Anne B. Claiborne", title = "Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary", isbn = "978-0-309-25315-4", abstract = "There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions.\n\n\nWith the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.", url = "https://nap.nationalacademies.org/catalog/13345/envisioning-a-transformed-clinical-trials-enterprise-in-the-united-states", year = 2012, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Transportation Research Board and National Academies of Sciences, Engineering, and Medicine", title = "System Trials to Demonstrate Mileage-Based Road Use Charges", abstract = "TRB\u2019s National Cooperative Highway Research Program (NCHRP) Web-Only Document 161: System Trials to Demonstrate Mileage-Based Road Use Charges explores factors to be considered in designing and implementing large-scale trials of mechanisms for collecting road-user charges based on vehicle-miles of travel.", url = "https://nap.nationalacademies.org/catalog/22910/system-trials-to-demonstrate-mileage-based-road-use-charges", year = 2010, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Stephen W. Lagakos and Alicia R. Gable", title = "Methodological Challenges in Biomedical HIV Prevention Trials", isbn = "978-0-309-11430-1", abstract = "The number of people infected with HIV or living with AIDS is increasing at unprecedented rates as various scientists, organizations, and institutions search for innovative solutions to combating and preventing the disease. At the request of the Bill & Melinda Gates Foundation, Methodological Challenges in Biomedical HIV Prevention Trials addresses methodological challenges in late-stage nonvaccine biomedical HIV prevention trials with a specific focus on microbicide and pre-exposure prophylaxis trials. This book recommends a number of ways to improve the design, monitoring, and analysis of late-stage clinical trials that evaluate nonvaccine biomedical interventions. The objectives include identifying a beneficial method of intervention, enhancing quantification of the impact, properly assessing the effects of using such an intervention, and reducing biases that can lead to false positive trial results.\n\nAccording to Methodological Challenges in Biomedical HIV Prevention Trials, the need to identify a range of effective, practical, and affordable preventive strategies is critical. Although a large number of promising new HIV prevention strategies and products are currently being tested in late-stage clinical trials, these trials face a myriad of methodological challenges that slow the pace of research and limit the ability to identify and fully evaluate effective biomedical interventions. \n ", url = "https://nap.nationalacademies.org/catalog/12056/methodological-challenges-in-biomedical-hiv-prevention-trials", year = 2008, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Margie Patlak and Sharyl Nass", title = "Improving the Quality of Cancer Clinical Trials: Workshop Summary", isbn = "978-0-309-11668-8", abstract = "Scientists and clinicians seek a new paradigm that could improve the efficiency, cost-effectiveness, and overall success rate of cancer clinical trials, while maintaining the highest standards of quality. \n\nTo explore innovative paradigms for cancer clinical trials and other ways to improve their quality, the National Cancer Policy Forum held a workshop, Improving the Quality of Cancer Clinical Trials, in Washington, DC. The main goals of the workshop were to examine new approaches to clinical trial design and execution that would:\n (1) better inform decisions and plans of those responsible for developing new cancer therapies \n (2) more rapidly move new diagnostic tests and treatments toward regulatory approval and use in the clinic \n (3) be less costly than current trials\n \nThe resulting workshop summary will serve as input to the deliberations of an Institute of Medicine committee that will develop consensus-based recommendations for moving the field of cancer clinical trials forward.\n", url = "https://nap.nationalacademies.org/catalog/12146/improving-the-quality-of-cancer-clinical-trials-workshop-summary", year = 2008, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council", title = "The Prevention and Treatment of Missing Data in Clinical Trials", isbn = "978-0-309-15814-5", abstract = "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. \n\nMissing 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. \n\nThe 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.", url = "https://nap.nationalacademies.org/catalog/12955/the-prevention-and-treatment-of-missing-data-in-clinical-trials", year = 2010, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council", editor = "Lisa Towne and Margaret Hilton", title = "Implementing Randomized Field Trials in Education: Report of a Workshop", isbn = "978-0-309-09192-3", abstract = "The central idea of evidence-based education-that education policy and practice ought to be fashioned based on what is known from rigorous research-offers a compelling way to approach reform efforts. Recent federal trends reflect a growing enthusiasm for such change. Most visibly, the 2002 No Child Left Behind Act requires that \"scientifically based [education] research\" drive the use of federal education funds at the state and local levels. This emphasis is also reflected in a number of government and nongovernment initiatives across the country. As consensus builds around the goals of evidence-based education, consideration of what it will take to make it a reality becomes the crucial next step. In this context, the Center for Education of the National Research Council (NRC) has undertaken a series of activities to address issues related to the quality of scientific education research. In 2002, the NRC released Scientific Research in Education (National Research Council, 2002), a report designed to articulate the nature of scientific education research and to guide efforts aimed at improving its quality. Building on this work, the Committee on Research in Education was convened to advance an improved understanding of a scientific approach to addressing education problems; to engage the field of education research in action-oriented dialogue about how to further the accumulation of scientific knowledge; and to coordinate, support, and promote cross-fertilization among NRC efforts in education research. The main locus of activity undertaken to meet these objectives was a year-long series of workshops. This report is a summary of the third workshop in the series, on the implementation and implications of randomized field trials in education.", url = "https://nap.nationalacademies.org/catalog/10943/implementing-randomized-field-trials-in-education-report-of-a-workshop", year = 2004, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Margie Patlak and Sharyl Nass and Christine Micheel", title = "Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary", isbn = "978-0-309-12867-4", abstract = "The NCI-sponsored cooperative groups have made important contributions to improving treatment for many types of cancer, including breast, ovarian, colorectal, and childhood cancers. Cooperative group research has been instrumental in establishing innovative treatments that improve outcomes and quality of life. Despite these successes, the Cooperative Group Program has faced a number of challenges that threaten its effectiveness.\nTo address this problem, the National Cancer Policy Forum (NCPF) convened a workshop titled \"Multi-Center Phase III Clinical Trials and NCI Cooperative Groups\" in Washington, DC, on July 1-2, 2008. The purpose of the workshop was to outline the challenges that the public clinical cancer research enterprise faces, and to identify possible solutions to these challenges.", url = "https://nap.nationalacademies.org/catalog/12535/multi-center-phase-iii-clinical-trials-and-nci-cooperative-groups", year = 2009, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report", isbn = "978-0-309-10078-6", abstract = "To improve public confidence in clinical research, a number of public and private groups have called for a publicly accessible, comprehensive, and transparent registry of relevant information on clinical trials for drugs and biologics. The public and various entities within the medical community (health care providers, researchers, medical journal editors, pharmaceutical companies, health insurers, and regulators) have different expectations and perceived needs regarding a public clinical trial registry.\n\nThe IOM Committee on Clinical Trial Registries hosted a workshop on June 27, 2005, to obtain much-needed input from members of the public, public advocate groups, and the broader community of journal editors, pharmaceutical and biotech leaders, NIH, and the FDA. Participants discussed the data elements that have been at the core of debate and commented on issues of compliance and implementation of a national clinical trial registry.\n\nDeveloping a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report inlcudes discussions at the workshop centered on the following five concepts, and are described within this report: 1) Purpose, 2) Which Trials to Include, 3) Delayed Disclosure Mechanism, 4) Reporting Results of Completed Trials, and 5) Compliance.\n ", url = "https://nap.nationalacademies.org/catalog/11561/developing-a-national-registry-of-pharmacologic-and-biologic-clinical-trials", year = 2006, publisher = "The National Academies Press", address = "Washington, DC" }