Envisioning A Transformed Clinical Trials Enterprise For 2030 Proceedings Of A Workshop

Author : National Academies Of Sciences Engineeri,National Academies of Sciences Engineering and Medicine,Health And Medicine Division,Board On Health Sciences Policy,Forum on Drug Discovery Development and Translation
Publisher : National Academies Press
Page : 128 pages
File Size : 53,5 Mb
Release : 2022-08-09
Category : Medical
ISBN : 0309269288

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Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop by National Academies Of Sciences Engineeri,National Academies of Sciences Engineering and Medicine,Health And Medicine Division,Board On Health Sciences Policy,Forum on Drug Discovery Development and Translation Pdf

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. Looking 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.

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 248 pages
File Size : 51,6 Mb
Release : 2012-10-13
Category : Medical
ISBN : 9780309253154

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Envisioning a Transformed Clinical Trials Enterprise in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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. With 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.

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 151 pages
File Size : 45,9 Mb
Release : 2010-10-22
Category : Medical
ISBN : 9780309163354

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Transforming Clinical Research in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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 the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 127 pages
File Size : 49,5 Mb
Release : 2019-11-16
Category : Medical
ISBN : 9780309494885

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Virtual Clinical Trials by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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. On 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.

Author : Institute of Medicine,Board on Health Sciences Policy,Clinical Research Roundtable
Publisher : National Academies Press
Page : 97 pages
File Size : 44,6 Mb
Release : 2003-07-25
Category : Medical
ISBN : 9780309089463

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Exploring Challenges, Progress, and New Models for Engaging the Public in the Clinical Research Enterprise by Institute of Medicine,Board on Health Sciences Policy,Clinical Research Roundtable Pdf

This report is a summary of a workshop focused on exploring the role of the public in the Clinical Research Enterprise. The Clinical Research Enterprise depends upon practitioners, policy makers, and others for participation in trials, ethical review of research, and continued support of research funding. However, the role of the public has expanded beyond this traditional model as consumers have begun to demand a role in the formulation of the research agenda and in the design, review, and pursuit of research. This report identifies four major challenges to the Clinical Research Enterprise: enhancing public participation in clinical research, which includes making the system safer and faster; developing the necessary information systems that are needed to make the clinical research enterprise a coordinated and seamless whole; fostering an adequately trained workforce; and ensuring adequate funding for clinical research. In addition, the report identifies two translational blocks-from basic science into clinical practice and from the clinical identification of things that work into broader application to improve medical care and the public's health. This workshop summary addresses the contribution of the public to overcoming these obstacles.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Board on Health Sciences Policy,Roundtable on Genomics and Precision Health,National Cancer Policy Forum,Forum on Neuroscience and Nervous System Disorders,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 163 pages
File Size : 43,8 Mb
Release : 2020-11-20
Category : Medical
ISBN : 9780309679152

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Reflections on Sharing Clinical Trial Data by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Board on Health Sciences Policy,Roundtable on Genomics and Precision Health,National Cancer Policy Forum,Forum on Neuroscience and Nervous System Disorders,Forum on Drug Discovery, Development, and Translation Pdf

On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop in Washington, DC, titled Sharing Clinical Trial Data: Challenges and a Way Forward. The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, and was designed to examine the current state of clinical trial data sharing and reuse and to consider ways in which policy, technology, incentives, and governance could be leveraged to further encourage and enhance data sharing. This publication summarizes the presentations and discussions from the workshop.

Author : Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health,National Cancer Policy Forum,Forum on Neuroscience and Nervous System Disorders,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 157 pages
File Size : 45,9 Mb
Release : 2013-05-07
Category : Medical
ISBN : 9780309268776

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Sharing Clinical Research Data by Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health,National Cancer Policy Forum,Forum on Neuroscience and Nervous System Disorders,Forum on Drug Discovery, Development, and Translation Pdf

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 within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Genomics and Precision Health,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 143 pages
File Size : 44,9 Mb
Release : 2020-11-28
Category : Medical
ISBN : 9780309679596

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The Role of Digital Health Technologies in Drug Development by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Genomics and Precision Health,Forum on Drug Discovery, Development, and Translation Pdf

On March 24, 2020, a 1-day public workshop titled The Role of Digital Health Technologies in Drug Development was convened by the National Academies of Sciences, Engineering, and Medicine. This workshop builds on prior efforts to explore how virtual clinical trials facilitated by digital health technologies (DHTs) might change the landscape of drug development. To explore the challenges and opportunities in using DHTs for improving the probability of success in drug R&D, enabling better patient care, and improving precision medicine, the workshop featured presentations and panel discussions on the integration of DHTs across all phases of drug development. Throughout the workshop, participants considered how DHTs could be applied to achieve the greatest impactâ€"and perhaps even change the face of how clinical trials are conductedâ€"in ways that are also ethical, equitable, safe, and effective. This publication summarizes the presentations and discussions from the workshop.

Author : Institute of Medicine,Board on Health Sciences Policy,Clinical Research Roundtable
Publisher : National Academies Press
Page : 120 pages
File Size : 53,7 Mb
Release : 2002-06-14
Category : Medical
ISBN : 9780309182904

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The Role of Purchasers and Payers in the Clinical Research Enterprise by Institute of Medicine,Board on Health Sciences Policy,Clinical Research Roundtable Pdf

In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.

Author : Forum on Drug Discovery Development and Translation,Forum on Neuroscience and Nervous System Disorders,National Cancer Policy Forum,Roundtable on Translating Genomic-Based Research on Health,Board on Health Sciences Policy,Institute Of Medicine
Publisher : Unknown
Page : 156 pages
File Size : 49,9 Mb
Release : 2013-05-07
Category : Electronic
ISBN : 0309384842

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Sharing Clinical Research Data by Forum on Drug Discovery Development and Translation,Forum on Neuroscience and Nervous System Disorders,National Cancer Policy Forum,Roundtable on Translating Genomic-Based Research on Health,Board on Health Sciences Policy,Institute Of Medicine Pdf

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 within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Trial Registries
Publisher : National Academies Press
Page : 124 pages
File Size : 54,6 Mb
Release : 2006-07-12
Category : Medical
ISBN : 9780309100786

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Trial Registries Pdf

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. The 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. Developing 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.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Population Health and Public Health Practice,Roundtable on the Promotion of Health Equity and the Elimination of Health Disparities
Publisher : National Academies Press
Page : 85 pages
File Size : 43,7 Mb
Release : 2016-09-24
Category : Medical
ISBN : 9780309443579

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Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Population Health and Public Health Practice,Roundtable on the Promotion of Health Equity and the Elimination of Health Disparities Pdf

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.

Author : Anonim
Publisher : Unknown
Page : 128 pages
File Size : 48,5 Mb
Release : 2018
Category : Electronic
ISBN : OCLC:1048121923

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Examining the Impact of Real-World Evidence on Medical Product Development by Anonim Pdf

Author : Rieckmann, Marco
Publisher : UNESCO Publishing
Page : 67 pages
File Size : 55,9 Mb
Release : 2017-03-20
Category : Electronic
ISBN : 9789231002090

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Education for Sustainable Development Goals by Rieckmann, Marco Pdf

Author : National Intelligence Council
Publisher : Cosimo Reports
Page : 158 pages
File Size : 53,5 Mb
Release : 2021-03
Category : Electronic
ISBN : 1646794974

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Global Trends 2040 by National Intelligence Council Pdf

"The ongoing COVID-19 pandemic marks the most significant, singular global disruption since World War II, with health, economic, political, and security implications that will ripple for years to come." -Global Trends 2040 (2021) Global Trends 2040-A More Contested World (2021), released by the US National Intelligence Council, is the latest report in its series of reports starting in 1997 about megatrends and the world's future. This report, strongly influenced by the COVID-19 pandemic, paints a bleak picture of the future and describes a contested, fragmented and turbulent world. It specifically discusses the four main trends that will shape tomorrow's world: - Demographics-by 2040, 1.4 billion people will be added mostly in Africa and South Asia. - Economics-increased government debt and concentrated economic power will escalate problems for the poor and middleclass. - Climate-a hotter world will increase water, food, and health insecurity. - Technology-the emergence of new technologies could both solve and cause problems for human life. Students of trends, policymakers, entrepreneurs, academics, journalists and anyone eager for a glimpse into the next decades, will find this report, with colored graphs, essential reading.