Patient self-reported data has become increasingly important in today's clinical trials. Trials in some disease indications rely upon patient recorded diary data as the primary endpoint to demonstrate drug efficacy - including, for example, indications such as insomnia, migraine and pain. In addition, improvements in quality of life measured using patient questionnaires can now be included as claims on drug labelling. Traditionally these data have been collected using paper questionnaires and diaries issued to subjects. Regulators and the industry have become increasingly aware of the limitations of recording patient reported outcomes data on paper including data quality and integrity issues. As a result there is a growing interest in collection of patient reported outcomes data using electronic means (ePRO). Solutions include handheld PDAs, Interactive Voice Response (IVR) systems, and other site-based hardware such as touchscreen PCs. Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern the community. These include: ¢ How should instruments developed on paper be adapted for electronic use, and what degree of validation should be done between paper and electronic forms? ¢ How can researchers ensure they are complying with regulatory requirements including the PRO guidance published by FDA in 2009 when using ePRO solutions? ¢ Can fewer patients be exposed in a clinical trial as a result of improved data quality obtained using electronic diaries? ¢ What type of solution should be used for certain patient populations and protocols, and how can ePRO solutions be designed optimally to increase patient acceptability and compliance? Bill Byrom and Brian Tiplady's ePro addresses all these issues, reviews the new FDA guidance, and provides a very contemporary view on this important subject.
In 1996, a groundbreaking television drama debuted on the Fox network. Created by Chris Carter, Millennium tells the story of Frank Black (Lance Henriksen), a legendary forensic profiler gifted with the ability to see into the minds of killers. Through his work as a consultant with the F.B.I. and the mysterious Millennium Group, the series offers a thoughtful exploration of the nature and manifestations of evil in the modern world. Back to Frank Black offers an unprecedented volume of material exploring this landmark series. With forewords from Lance Henriksen and Frank Spotnitz and an introduction by series creator Chris Carter, the collection features interviews with cast and crew as well as in-depth essays analyzing Millennium's characters, themes, and enduring legacy. Inspired by the growing movement to return this iconic hero to the screen, Back to Frank Black finds its focus in an incomparable figure of hope: Frank Black. We need him now more than ever.
Expectations have been raised in Australia and comparable countries for an 'education revolution' that will secure success for all students in all settings. Such a revolution must ensure the alignment of educational outcomes, the skills required for a strong economy, and the needs of a harmonious society. Why not the Best Schools?
This book is an easy-to-read introduction to the principles and methods of building procurement and is aimed at first year students or non-cognate graduates starting out on a career in construction, property, quantity surveying and construction management. The book starts with a brief introduction to the construction industry, including how the industry is organised into contractors, consultants and clients. After a discussion of the historical development of procurement methods, which show a steady shift of risk and responsibility towards the supply side (contractors), the various roles and responsibilities which must be carried out in any project are discussed in detail. The aim is to show the reader that procurement routes are effectively a permutation of these responsibilities between the various parties. The book then explains the various methods by which the contractor(s) are paid, either by pre-negotiated lump sums or by some form of cost reimbursement. Variants of these two systems are also discussed. Several chapters are given to the detailed discussion of the main procurement routes together with the appropriate standard forms of contract designed for that route. More modern developments such as Private Financing and PPP are discussed and a chapter covering emerging trends in procurement completes the book. Containing discussion points, chapter summaries and case studies, this book is ideal for use in a variety of degree programs and courses across the built environment and engineering.
The Future of Pharma examines the causes of the industry's potential decline and offers a convincing and rigorous analysis of the options open to it. What emerges is a landscape defined, on the one hand, by the changing marketplace of mass-market consumers, institutional healthcare systems and wealthy individuals; and on the other by the alternate sources of commercial value - innovative therapies; super-efficient processes, supply chains and operations; and closer customer relations and increasingly tailored health services.
The procurement stage of the building process is critical to the success of any building project, and as such must be understood by everybody entering the industry. Introduction to Building Procurement is designed to familiarize the novice with the principles and methods of building procurement, starting at the most basic level. With chapter summaries and tutorial questions provided throughout the book, the reader will get to grips with the following topics: the structure of the construction industry the nature of clients the historical development of building procurement methods the roles and responsibilities carried out in any project. Having developed the necessary background knowledge, the reader is then introduced to the more complex aspects of procurement in detail, such as: methods of paying contractors the main procurement routes in use standard forms of contract. The concluding chapter discusses emerging procurement trends, and speculates on future developments to bring the reader right up to speed with the modern industry. With its clear layout and highly accessible approach, Introduction to Building Procuremen is the perfect introductory text for undergraduate students and professionals starting out on a career in quantity surveying, construction project management or construction commercial management.
By any standard, the pharmaceutical industry's history has been a successful one. In addition to its profits and shareholder dividends, it has been seen by investors as relatively low risk and, largely, counter-cyclical to stock market trends. However, that important contribution appears to be petering out, with significant global implications for employees, shareholders, governments and patients. This is not just caused by the economic crisis. Long before this, several distinct but related streams of evidence emerged that now point to the stalling of the pharmaceutical industry. The Future of Pharma examines the causes of the industry's potential decline and offers a convincing and rigorous analysis of the options open to it. What emerges is a landscape defined, on the one hand, by the changing marketplace of mass-market consumers, institutional healthcare systems and wealthy individuals; and on the other by the alternate sources of commercial value - innovative therapies; super-efficient processes, supply chains and operations; and closer customer relations and increasingly tailored health services. The challenges to the pharmaceutical industry now and in the medium and long-term are very significant. Brian Smith's highly readable research findings are a wake-up call and a first step forward for anyone concerned with the future of the industry; whether executive, customer, policymaker or investor.
Why not the best schools is drawn from a major research project undertaken by Brain Caldwell and Jessica Harris involving studies of successful schools in six countries (Finland, Wales, Australia, USA, China, England). It compares a total of 30 schools and examines the conditions necessary for schools anywhere to improve and attain high standard for students."--Publisher's website.
What has led to the church's vibrant growth throughout the Global South? Brian Stiller identifies five key factors that have shaped the church, from a renewed openness to the move of the Holy Spirit to the empowerment of indigenous leadership. Discover the surprising story of the global advance of the gospel. And be encouraged that Jesus' witness continues to the ends of the earth.
Preeminent designer Barry Dixon approaches each project with the design philosophy that the greatest quality ahome might possess is that of innate, soulful hospitality. His work features a masterful blend of traditional and contemporary décor that mixes color and texture in astounding ways. Barry Dixon Interiors exemplifies Dixon’s belief that our homes reflect our past, emanate our present and suggest our future.From a Manhattan loft choreographed for entertaining to Arts and Crafts in a woodland glade, to embassy elegance in Washington, D.C., Barry Dixon has seen and designed it all. From a Manhattan loft choreographed for entertaining to Arts and Crafts in a woodland glade, to embassy elegance in Washington, D.C., Barry Dixon has seen and designed it all. As one of America's top up-and-coming designers, Dixon's work is a masterful blend of traditional and contemporary that mixes color and texture in creative ways that have clients across the country clamoring for his designs. Barry Dixon Interiors (subtitle?), written by well-known author Brian Coleman (Scalamandre; Farrow & Ball), with luminous photography by Edward Addeo and a foreword by Sherrie Donghia, is the highly-anticipated first book to highlight Dixon's innovative designs. His work has been featured in scores of publications, including House Beautiful, Better Homes & Gardens, Traditional Home, and more, and Dixon's own furniture and soft furnishings line is carried in showrooms nationally. Brian D. Coleman, MD, divides his time between Seattle and New York. His articles have appeared in magazines ranging from Old House Journal, where he is the West Coast editor, to Period Living in the U.K. Brian is the author of seven books on the decorative arts, including the recent hits Farrow & Ball and Cottages. Edward Addeo is a New York-based photographer whose work has appeared in Vogue, House Beautiful, and the New York Times magazine among other publications. He has also photographed several books, including Cherished Objects and The Art of The Party. He lives with his family in New York. www.barrydixon.com.
Collecting Jessica Jones (2016) #7-12. Jessica Jones is back where she belongs - in her own comic, and taking on cases as Alias Investigations! But as the most dangerous book on the stands digs even deeper into the new mysteries of the Marvel Universe, Jessica has uncovered a truly startling secret. Is this case too hot for even her? Will it shatter everything she has built for herself? Can she put the pieces of her life back together...or is it already too late?
The un-Bond-like British spy is back—from a multimillion-selling author who “hauls you aboard and won’t let you off until the roller coaster stops” (Los Angeles Times). “If Brian Freemantle isn’t the best writer of spy novels around, he’s certainly, along with John le Carré, in the top two.” —The Philadelphia Inquirer In his long-running Charlie Muffin series, Freemantle gives us an atypical British spy. Charlie is neither high cultured nor well mannered. He’s working-class, scruffy, and fond of a drink. But he gets the job done . . . Charlie Muffin U.S.A.: Officially declared dead, Charlie can breathe again without the intelligence forces of Great Britain and the United States hunting him. He puts his espionage skills to work for an English insurance company, ensuring the security of the Romanov stamps, a priceless collection assembled before the Russian Revolution. When the American government decides to use them as bait for a vicious drug lord, Charlie gets stuck in the middle. But he’s not licked yet. “Fine, lightweight-caper entertainment.” —Kirkus Reviews Madrigal for Charlie Muffin: Since British intelligence first turned on him and forced him to go into hiding, the ex-spy has had a rough few years. He takes a job for his only friend, Rupert Willoughby, who sends Charlie to Rome to check the security system for some valuable jewels. But Charlie has chosen the wrong time to visit the Eternal City. There’s a mole in the British embassy there, and with agents of the East and West homing in fast, he’s soon caught between a rock and a hard place. “The most degenerate and lovable character ever cast in the role of secret agent.” —Manchester Evening News The Blind Run: In this Edgar Award finalist, after a trumped-up trial, Charlie lands in jail for treason. But when KGB agents stage a prison break to free his fellow inmate, a convicted British traitor, Charlie also flees to Moscow. There he meets Natalia Fedova, the KGB interrogator assigned to determine if his defection is genuine. For anyone else, the risk would be suicidal. But for Charlie, the greatest danger may be falling in love. “Unpretentious, sly rather than stately, but powerful nonetheless: the best of the Muffin novels thus far.” —Kirkus Reviews See Charlie Run: Back at work for British intelligence, Charlie finally has a real assignment: A KGB agent in Tokyo wants to defect to the other side. Charlie’s role is to bring him across. But as he himself has learned from all those evasive years, there’s never anything simple or safe about running away. “Freemantle has merged the good humor of a Lawrence Block thriller, the seriousness of a le Carré spy novel and the slam-bang adventure of a popular espionage caper.” —Publishers Weekly
An ex-spy is about to upend the world of international intrigue. Meet “the most degenerate and lovable character ever cast in the role of secret agent” (Manchester Evening News). Charlie Muffin is back at rock bottom. The ex-spy has had a rough few years since British intelligence first turned on him and forced him to go into hiding. He’s drinking again, forgetting things—getting soft. He hasn’t even noticed the tap on his phone. Though Charlie doesn’t know it yet, the walls are closing in again. He takes a job for his only friend, Rupert Willoughby, who sends Charlie to Rome to check the security system for some valuable jewels. Charlie has chosen the wrong time to visit the Eternal City. There’s a mole in the British embassy there, and the agents of the East and West are homing in fast. Charlie, unlucky as always, is about to find himself caught between a very solid rock and an equally hard place. This ebook features an illustrated biography of Brian Freemantle including rare photos from the author’s personal collection.
The only comprehensive guide to the clinical management of hematologic and lymphatic cancers 4 STAR DOODY'S REVIEW! "This will be an ideal and a must-have book for anyone involved in the daily care of patients with hematologic malignancies. It would be particularly useful for physicians-in-training trying to make sense of the ever more complicated treatment plans for these patients....This is a unique book that provides easily accessible information that would be useful to almost any practicing oncologist or hematologist."--Doody's Review Service Filling an unmet need in the clinical literature, this commanding, just-in-time reference sheds light on the full spectrum of cancers in the blood, bone marrow, and lymphatic system (leukemia, lymphoma, myeloma). Clinical Malignant Hematology is edited by staff members from the renowned Taussig Cancer Center at the Cleveland Clinic, which has pioneered some of the most important clinical discoveries and treatment trends in recent years. Look inside and you'll see a consistent, unified patient management strategy in each chapter, as well as a streamlined three-section format that expertly examines ontogeny and physiology of blood cells, myeloid neoplasia, and lymphoid neoplasia. You'll also find never-before-published perspectives and precise recommendations for dosing and other critical areas that reflect the latest scholarship of this increasingly vital field. Features Full coverage of all treatment modalities --chemotherapy, monoclonal antibodies, and hematopoietic stem cell transplantation Strong background chapters that offer guidance on how to address treatment complications and other supportive care issues A detailed, regimen-based orientation in each chapter Abundance of clinical pictures and photomicrographs displaying examples of peripheral blood smears and bone marrow aspirates Uniform headings and tables in each chapter, which convey specific recommendations on the work-up, staging, diagnosis, differential diagnosis, and treatment of hematologic malignancies Nearly 200 illustrations
Patient self-reported data has become increasingly important in today's clinical trials. Trials in some disease indications rely upon patient recorded diary data as the primary endpoint to demonstrate drug efficacy - including, for example, indications such as insomnia, migraine and pain. In addition, improvements in quality of life measured using patient questionnaires can now be included as claims on drug labelling. Traditionally these data have been collected using paper questionnaires and diaries issued to subjects. Regulators and the industry have become increasingly aware of the limitations of recording patient reported outcomes data on paper including data quality and integrity issues. As a result there is a growing interest in collection of patient reported outcomes data using electronic means (ePRO). Solutions include handheld PDAs, Interactive Voice Response (IVR) systems, and other site-based hardware such as touchscreen PCs. Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern the community. These include: ¢ How should instruments developed on paper be adapted for electronic use, and what degree of validation should be done between paper and electronic forms? ¢ How can researchers ensure they are complying with regulatory requirements including the PRO guidance published by FDA in 2009 when using ePRO solutions? ¢ Can fewer patients be exposed in a clinical trial as a result of improved data quality obtained using electronic diaries? ¢ What type of solution should be used for certain patient populations and protocols, and how can ePRO solutions be designed optimally to increase patient acceptability and compliance? Bill Byrom and Brian Tiplady's ePro addresses all these issues, reviews the new FDA guidance, and provides a very contemporary view on this important subject.
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