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Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.
In the United States, approximately 14 million people have had cancer and more than 1.6 million new cases are diagnosed each year. However, more than a decade after the Institute of Medicine (IOM) first studied the quality of cancer care, the barriers to achieving excellent care for all cancer patients remain daunting. Care often is not patient-centered, many patients do not receive palliative care to manage their symptoms and side effects from treatment, and decisions about care often are not based on the latest scientific evidence. The cost of cancer care also is rising faster than many sectors of medicine--having increased to $125 billion in 2010 from $72 billion in 2004--and is projected to reach $173 billion by 2020. Rising costs are making cancer care less affordable for patients and their families and are creating disparities in patients' access to high-quality cancer care. There also are growing shortages of health professionals skilled in providing cancer care, and the number of adults age 65 and older--the group most susceptible to cancer--is expected to double by 2030, contributing to a 45 percent increase in the number of people developing cancer. The current care delivery system is poorly prepared to address the care needs of this population, which are complex due to altered physiology, functional and cognitive impairment, multiple coexisting diseases, increased side effects from treatment, and greater need for social support. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis presents a conceptual framework for improving the quality of cancer care. This study proposes improvements to six interconnected components of care: (1) engaged patients; (2) an adequately staffed, trained, and coordinated workforce; (3) evidence-based care; (4) learning health care information technology (IT); (5) translation of evidence into clinical practice, quality measurement and performance improvement; and (6) accessible and affordable care. This report recommends changes across the board in these areas to improve the quality of care. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis provides information for cancer care teams, patients and their families, researchers, quality metrics developers, and payers, as well as HHS, other federal agencies, and industry to reevaluate their current roles and responsibilities in cancer care and work together to develop a higher quality care delivery system. By working toward this shared goal, the cancer care community can improve the quality of life and outcomes for people facing a cancer diagnosis.
This volume examines in detail the role of chronic inflammatory processes in the development of several types of cancer. Leading experts describe the latest results of molecular and cellular research on infection, cancer-related inflammation and tumorigenesis. Further, the clinical significance of these findings in preventing cancer progression and approaches to treating the diseases are discussed. Individual chapters cover cancer of the lung, colon, breast, brain, head and neck, pancreas, prostate, bladder, kidney, liver, cervix and skin as well as gastric cancer, sarcoma, lymphoma, leukemia and multiple myeloma.
Freedom in the World, the Freedom House flagship survey whose findings have been published annually since 1972, is the standard-setting comparative assessment of global political rights and civil liberties. The survey ratings and narrative reports on 194 countries and 14 territories are used by policymakers, the media, international corporations, civic activists, and human rights defenders to monitor trends in democracy and track improvements and setbacks in freedom worldwide. The Freedom in the World political rights and civil liberties ratings are determined through a multi-layered process of research and evaluation by a team of regional analysts and eminent scholars. The analysts used a broad range of sources of information, including foreign and domestic news reports, academic studies, nongovernmental organizations, think tanks, individual professional contacts, and visits to the region, in conducting their research. The methodology of the survey is derived in large measure from the Universal Declaration of Human Rights, and these standards are applied to all countries and territories, irrespective of geographical location, ethnic or religious composition, or level of economic development.
While many effective interventions can reduce cancer risk, incidence, and death, as well as enhance quality of life, they are of no benefit if they cannot be delivered to those in need. In the face of increasingly dynamic and resource-constrained conditions, implementation science plays a critical role in delivering cancer control practices. This 30-page workbook was written by members of the NCI (National Cancer Institute) implementation Science team and reviewed by nearly 100 public health practitioners and implementation science researchers. Through summaries of key theories, methods, and models, the guide shows how greater use of implementation science can support the effective adoption of evidence-based interventions. Case studies illustrate how practitioners are successfully applying implementation science in their cancer control programs
This book explores in depth the relation between physical activity and cancer control, including primary prevention, coping with treatments, recovery after treatments, long-term survivorship, secondary prevention, and survival. The first part of the book presents the most recent research on the impact of physical activity in preventing a range of cancers. In the second part, the association between physical activity and cancer survivorship is addressed. The effects of physical activity on supportive care endpoints (e.g., quality of life, fatigue, physical functioning) and disease endpoints (e.g., biomarkers, recurrence, survival) are carefully analyzed. In addition, the determinants of physical activity in cancer survivors are discussed, and behavior change strategies for increasing physical activity in cancer survivors are appraised. The final part of the book is devoted to special topics, including the relation of physical activity to pediatric cancer survivorship and to palliative cancer care.