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Explores the origins of contemporary drug regulation and the modern clinical trial.
Improving your craft is a key skill for product and user experience professionals working in the digital era. There are many established methods of product development to inspire and focus teams—Sprint, Lean, Agile, Kanban—all of which focus on solutions to customer and business problems. Enter XDPD, or Experiment-Driven Product Development—a new approach that turns the spotlight on questions to be answered, rather than on solutions. Within XDPD, discovery is a mindset, not a project phase. In Experiment-Driven Product Development, author Paul Rissen introduces a philosophy of product development that will hone your skills in discovery, research and learning. By guiding you through a practical, immediately applicable framework, you can learn to ask, and answer, questions which will supercharge your product development, making teams smarter and better at developing products and services that deliver for users and businesses alike. When applying the XDPD framework within your organization, the concept of an experiment—a structured way of asking, and answering, questions—becomes the foundation of almost everything you do, instilling a constant sense of discovery that keeps your team inspired. All types of activities, from data analysis to writing software, are seen through the lens of research. Rather than treating research as a separate task from the rest of product development, this book approaches the entire practice as one of research and continuous discovery. Designing successful experiments takes practice. That’s where Rissen’s years of industry expertise come in. In this book, you are given step-by-step tools to ensure that meaningful, efficient progress is made with each experiment. This approach will prove beneficial to your team, your users, and most importantly, to your product’s lasting success. Experiment-Driven Product Development offers a greater appreciation of the craft of experimentation and helps you adapt it in your own context. In our modern age of innovation, XDPD can put you ahead. Go forth and experiment! What You Will LearnKnow how to approach product development in a leaner, more efficient wayUnderstand where and when experiments can be useful, and how they fit into pre-existing organization environments and processesRealize why you should be thinking about the simplest, useful thing rather than the minimum, viable productDiscover how to break down feature and design ideas into the assumptions and the premises that lie behind themAppreciate the importance of designing your experiments, and the statistical concepts that underpin their successMaster the art of communicating the results of experiments back to stakeholders, and help the results guide what happens next Who This Book is For Professionals working in digital product design and development, user experience, and service design. This book is best suited for those who work on digital products every day and want to adopt better approaches to gaining knowledge about their users, what works, and what does not work.
What role have experiments played, and should they play, in physics? How does one come to believe rationally in experimental results? The Neglect of Experiment attempts to provide answers to both of these questions. Professor Franklin's approach combines the detailed study of four episodes in the history of twentieth century physics with an examination of some of the philosophical issues involved. The episodes are the discovery of parity nonconservation ( or the violation of mirror symmetry) in the 1950s; the nondiscovery of parity nonconservation in the 1930s, when the results of experiments indicated, at least in retrospect, the symmetry violation, but the significance of those results was not realized; the discovery and acceptance of CP ( combined parity-charge conjugations, paricle-antiparticle) symmetry; and Millikan's oil-drop experiment. Franklin examines the various roles that experiment plays, including its role in deciding between competing theories, confirming theories, and calling fo new theories. The author argues that one can provide a philosophical justification for these roles. He contends that if experiment plays such important roles, then one must have good reason to believe in experimental results. He then deals with deveral problems concerning such reslults, including the epistemology of experiment, how one comes to believe rationally in experimental results, the question of the influence of theoretical presuppositions on results, and the problem of scientific fruad. This original and important contribution to the study of the philosophy of experimental science is an outgrowth of many years of research. Franklin brings to this work more than a decade of experience as an experimental high-energy physicist, along with his significant contributions to the history and philosophy of science.
The modern classic of race and medicine updated with an additional chapter on the Tuskegee experiment's legacy in the age of AIDS.
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.
Scientific experimentation with humans has a long history. Combining elements of history of science with history of medicine, The Uses of Humans in Experiment illustrates how humans have grappled with issues of consent, and how scientists have balanced experience with empiricism to achieve insights for scientific as well as clinical progress. The modern incarnation of ethics has often been considered a product of the second half of the twentieth century, as enshrined in international laws and codes, but these authors remind us that this territory has long been debated, considered, and revisited as a fundamental part of the scientific enterprise that privileges humans as ideal subjects for advancing research.
NATIONAL BOOK CRITICS CIRCLE AWARD WINNER • The first full history of Black America’s shocking mistreatment as unwilling and unwitting experimental subjects at the hands of the medical establishment. No one concerned with issues of public health and racial justice can afford not to read this masterful book. "[Washington] has unearthed a shocking amount of information and shaped it into a riveting, carefully documented book." —New York Times From the era of slavery to the present day, starting with the earliest encounters between Black Americans and Western medical researchers and the racist pseudoscience that resulted, Medical Apartheid details the ways both slaves and freedmen were used in hospitals for experiments conducted without their knowledge—a tradition that continues today within some black populations. It reveals how Blacks have historically been prey to grave-robbing as well as unauthorized autopsies and dissections. Moving into the twentieth century, it shows how the pseudoscience of eugenics and social Darwinism was used to justify experimental exploitation and shoddy medical treatment of Blacks. Shocking new details about the government’s notorious Tuskegee experiment are revealed, as are similar, less-well-known medical atrocities conducted by the government, the armed forces, prisons, and private institutions. The product of years of prodigious research into medical journals and experimental reports long undisturbed, Medical Apartheid reveals the hidden underbelly of scientific research and makes possible, for the first time, an understanding of the roots of the African American health deficit. At last, it provides the fullest possible context for comprehending the behavioral fallout that has caused Black Americans to view researchers—and indeed the whole medical establishment—with such deep distrust.
Novel collection of essays addressing contemporary trends in political science, covering a broad array of methodological and substantive topics.
Human embryo research touches upon strongly felt moral convictions, and it raises such deep questions about the promise and perils of scientific progress that debate over its development has become a moral and political imperative. From in vitro fertilization to embryonic stem cell research, cloning, and gene editing, Americans have repeatedly struggled with how to define the moral status of the human embryo, whether to limit its experimental uses, and how to contend with sharply divided public moral perspectives on governing science. Experiments in Democracy presents a history of American debates over human embryo research from the late 1960s to the present, exploring their crucial role in shaping norms, practices, and institutions of deliberation governing the ethical challenges of modern bioscience. J. Benjamin Hurlbut details how scientists, bioethicists, policymakers, and other public figures have attempted to answer a question of great consequence: how should the public reason about aspects of science and technology that effect fundamental dimensions of human life? Through a study of one of the most significant science policy controversies in the history of the United States, Experiments in Democracy paints a portrait of the complex relationship between science and democracy, and of U.S. society's evolving approaches to evaluating and governing science's most challenging breakthroughs.
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. Small 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.