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Sharing Clinical Trial Data

Sharing Clinical Trial Data PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236

Book Description
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.

Sharing Clinical Trial Data

Sharing Clinical Trial Data PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236

Book Description
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.

Public Trials

Public Trials PDF Author: Lida Maxwell
Publisher:
ISBN: 019938374X
Category : Biography & Autobiography
Languages : en
Pages : 257

Book Description
There are certain moments, such as the American founding or the Civil Rights Movement, that we revisit again and again as instances of democratic triumph, and there are other moments that haunt us as instances of democratic failure. How should we view moments of democratic failure, when both the law and citizens forsake justice? Do such moments reveal a wholesale failure of democracy or a more contested failing, pointing to what could have been, and still might be? Public Trials reveals the considerable stakes of how we understand democratic failure. Maxwell argues against a tendency in the thinking of Plato, Rousseau and contemporary theorists to view moments of democratic failure as indicative of the failure of democracy, insomuch as such thinking leads to a deference to authority that unintentionally encourages complicity in elite and legal failures to assure justice. In contrast, what Maxwell calls "lost cause narratives" of democratic failure reveal the contingency of democratic failure by showing that things "could have been" otherwise -- and, with public action and response, might yet be. A politics of lost causes calls for democratic responsiveness to failure via practices of resistance, theatrical claims-making, and re-narration. Maxwell makes a powerful case for the politics of lost causes by examining public controversies over trials. She focuses on the dilemmas and diagnoses of democratic failure in four instances: Edmund Burke's speeches and writings on the Warren Hastings trial in late 18th century Britain, Emile Zola's writings on the Dreyfus Affair in late 19th century France, Hannah Arendt's writings on the Eichmann trial in 1960's Israel, and Kathryn Bigelow's recent narration of (the lack of) trials of alleged terrorist detainees in Zero Dark Thirty. Maxwell marshals her subtle, historically grounded readings of these texts to show the dangers of despairing of democracy altogether, as well as the necessity of re-narrating instances of democratic failure so as to cultivate public responsiveness to such failures in the future.

NPR

NPR PDF Author: Michael P. McCauley
Publisher: Columbia University Press
ISBN: 0231509952
Category : Performing Arts
Languages : en
Pages : 308

Book Description
The people who shaped America's public broadcasting system thought it should be "a civilized voice in a civilized community"—a clear alternative to commercial broadcasting. This book tells the story of how NPR has tried to embody this idea. Michael P. McCauley describes NPR's evolution from virtual obscurity in the early 1970s, when it was riddled with difficulties—political battles, unseasoned leadership, funding problems—to a first-rate broadcast organization. The book draws on a wealth of primary evidence, including fifty-seven interviews with people who have been central to the NPR story, and it places the network within the historical context of the wider U.S. radio industry. Since the late 1970s, NPR has worked hard to understand the characteristics of its audience. Because of this, its content is now targeted toward its most loyal listeners—highly educated baby-boomers, for the most part—who help support their local stations through pledges and fund drives.

The State Trials and the Politics of Justice in Later Stuart England

The State Trials and the Politics of Justice in Later Stuart England PDF Author: Brian Cowan
Publisher: Boydell & Brewer
ISBN: 1783276266
Category : History
Languages : en
Pages : 304

Book Description
The book discusses the 'state trial' as a legal process, a public spectacle, and a point of political conflict - a key part of how constitutional monarchy became constitutional.State trials provided some of the leading media events of later Stuart England. The more important of these trials attracted substantial public attention, serving as pivot points in the relationship between the state and its subjects. Later Stuart England has been known among legal historians for a series of key cases in which juries asserted their independence from judges. In political history, the government's sometimes shaky control over political trials in this period has long been taken as a sign of the waning power of the Crown. This book revisits the process by which the 'state trial' emerged as a legal proceeding, a public spectacle, a point of political conflict, and ultimately, a new literary genre. It investigates the trials as events, as texts, and as moments in the creation of historical memory. By the early nineteenth century, the publication and republication of accounts of the state trials had become a standard part of the way in which modern Britons imagined how their constitutional monarchy had superseded the absolutist pretensions of the Stuart monarchs. This book explores how the later Stuart state trials helped to create that world.tury, the publication and republication of accounts of the state trials had become a standard part of the way in which modern Britons imagined how their constitutional monarchy had superseded the absolutist pretensions of the Stuart monarchs. This book explores how the later Stuart state trials helped to create that world.tury, the publication and republication of accounts of the state trials had become a standard part of the way in which modern Britons imagined how their constitutional monarchy had superseded the absolutist pretensions of the Stuart monarchs. This book explores how the later Stuart state trials helped to create that world.tury, the publication and republication of accounts of the state trials had become a standard part of the way in which modern Britons imagined how their constitutional monarchy had superseded the absolutist pretensions of the Stuart monarchs. This book explores how the later Stuart state trials helped to create that world.

United States Attorneys' Manual

United States Attorneys' Manual PDF Author: United States. Department of Justice
Publisher:
ISBN:
Category : Justice, Administration of
Languages : en
Pages :

Book Description


The Case of Sacco and Vanzetti

The Case of Sacco and Vanzetti PDF Author: Felix Frankfurter
Publisher:
ISBN:
Category : Anarchism
Languages : en
Pages : 140

Book Description
On April 15, 1920, Parmenter, a paymaster, and Berardelli, his guard, were fired upon and killed. Sacco and Vanzetti were charged on May 5, 1920, with the crime of the murders, were indicted on September 14, 1920, and put to trial May 31, 1921, at Dedham, Norfolk County, Massachusetts. compare pages [3]-8.

Field Trials of Health Interventions

Field Trials of Health Interventions PDF Author: Peter G. Smith
Publisher:
ISBN: 0198732864
Category : Health & Fitness
Languages : en
Pages : 479

Book Description
This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.

Michigan Court Rules

Michigan Court Rules PDF Author: Kelly Stephen Searl
Publisher:
ISBN:
Category : Court rules
Languages : en
Pages : 520

Book Description


Model Rules of Professional Conduct

Model Rules of Professional Conduct PDF Author: American Bar Association. House of Delegates
Publisher: American Bar Association
ISBN: 9781590318737
Category : Law
Languages : en
Pages : 216

Book Description
The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.

The Big Trial

The Big Trial PDF Author: Lawrence M. Friedman
Publisher: University Press of Kansas
ISBN: 070062077X
Category : Law
Languages : en
Pages : 238

Book Description
The trial of O. J. Simpson was a sensation, avidly followed by millions of people, but it was also, in a sense, nothing new. One hundred years earlier the Lizzie Borden trial had held the nation in thrall. The names (and the crimes) may change, but the appeal is enduring—and why this is, how it works, and what it means are what Lawrence Friedman investigates in The Big Trial. What is it about these cases that captures the public imagination? Are the “headline trials” of our period different from those of a century or two ago? And what do we learn from them, about the nature of our society, past and present? To get a clearer picture, Friedman first identifies what certain headline trials have in common, then considers particular cases within each grouping. The political trial, for instance, embraces treason and spying, dissenters and radicals, and, to varying degrees, corruption and fraud. Celebrity trials involve the famous—whether victims, as in the case of Charles Manson, or defendants as disparate as Fatty Arbuckle and William Kennedy Smith—but certain high-profile cases, such as those Friedman categorizes as tabloid trials, can also create celebrities. The fascination of whodunit trials can be found in the mystery surrounding the case: Are we sure about O. J. Simpson? What about Claus von Bulow—tried, in another sensational case, for sending his wife into a coma.? An especially interesting type of case Friedman groups under the rubric worm in the bud. These are cases, such as that of Lizzie Borden, that seem to put society itself on trial; they raise fundamental social questions and often suggest hidden and secret pathologies. And finally, a small but important group of cases proceed from moral panic, the Salem witchcraft trials being the classic instance, though Friedman also considers recent examples. Though they might differ in significant ways, these types of trials also have important similarities. Most notably, they invariably raise questions about identity (Who is this defendant? A villain? An innocent unfairly accused?). And in this respect, The Big Trial shows us, the headline trial reflects a critical aspect of modern society. Reaching across the nineteenth and twentieth centuries to the latest outrage, from congressional hearings to lynching and vigilante justice to public punishment, from Dr. Sam Sheppard (the “fugitive”) to Jeffrey Dahmer (the “cannibal”), The Rosenbergs to Timothy McVeigh, the book presents a complex picture of headline trials as displays of power—moments of “didactic theater”" that demonstrate in one way or another whether a society is fair, whom it protects, and whose interest it serves.