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Randomized clinical trials are the gold standard for establishing many clinical practice guidelines and are central to evidence based medicine. Obtaining the best evidence through clinical trials must be done within the boundaries of rigorous science and ethical principles. One fundamental principle is that trials should not continue longer than necessary to reach their objectives. Therefore, trials must be monitored for recruitment progress, quality of data, adherence to patient care or prevention standards, and early evidence of benefit or harm. Frequently, a group of external experts, independent from the investigators and trial sponsor, is charged with this monitoring responsibility, especially for safety and early benefit. This group is referred to by various names, such as a data monitoring committee or a data and safety monitoring board. This book, through a series of case studies presented by many distinguished clinical trial experts, illustrates the complexity of this monitoring process. The editors provide an overview of the process and a summary of a multitude of the lessons learned from the cases presented. This book should be useful to anyone serving on a data and safety monitoring board, or planning to do so, for colleagues in academia, industry and governmental agencies, and for teaching students in biostatistics, epidemiology, clinical trials and medical ethics. No other text has as extensive a collection of cases which provide insight into the many issues, often conflicting, that must be examined before recommendations to continue or discontinue a trial can be made. While depth in statistical methods is not required, some familiarity with statistical design and analysis issues in clinical trials is helpful. The cases cover trials which were terminated early for convincing evidence of benefit, or for harmful effects. Cases with complex issues are also included. This series of cases should provide broad background information for potential moni

Biomathematics. Biometry. Biostatistics --- medische statistiek --- biostatistiek --- Clinical Trials --- Automatic Data Processing. --- Clinical trials --- Etudes cliniques --- Case Reports. --- Data processing. --- Case studies. --- Informatique --- Cas, Etudes de --- Clinical trials - Data processing. --- Controlled Clinical Trials as Topic --- Research --- Professional Staff Committees --- Clinical Trials as Topic --- Quality Assurance, Health Care --- Science --- Natural Science Disciplines --- Health Care Quality, Access, and Evaluation --- Epidemiologic Study Characteristics as Topic --- Evaluation Studies as Topic --- Health Care --- Epidemiologic Methods --- Disciplines and Occupations --- Health Care Evaluation Mechanisms --- Investigative Techniques --- Quality of Health Care --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Public Health --- Environment and Public Health --- Randomized Controlled Trials as Topic --- Biomedical Research --- Clinical Trials Data Monitoring Committees --- Mathematics --- Medicine --- Physical Sciences & Mathematics --- Health & Biological Sciences --- Mathematical Statistics --- Medical Research --- Data processing --- Statistics. --- Statistics for Life Sciences, Medicine, Health Sciences. --- Statistical analysis --- Statistical data --- Statistical methods --- Statistical science --- Econometrics --- Statistics .

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Blood Transfusion --- Transplantation Immunology --- Histocompatibility Testing --- Blood --- Transplantation of organs, tissues, etc. --- Transplantation immunology --- Sang --- Greffe (Chirurgie) --- Transfusion. --- Transfusion --- Immunologie --- Bloedtransfusies --- Orgaantransplantaties --- Hematologie --- transfusie --- transplantaties --- immunologie --- Immunology --- Blood Transfusion. --- Transplantation Immunology. --- Histocompatibility Testing. --- Transplantation of organs, tissues, etc --- Medical transplantation --- Organ transplantation --- Organ transplants --- Organs (Anatomy) --- Surgical transplantation --- Tissue transplantation --- Tissues --- Transplants, Organ --- Surgery --- Preservation of organs, tissues, etc. --- Procurement of organs, tissues, etc. --- Blood transfusion --- Blood transfusion therapy --- Hemotherapy --- Transfusion medicine --- Transfusion of blood --- Transfusion therapy --- Transfusion therapy, Blood --- Blood banks --- Blood groups --- Hospitals --- Transfusion-free surgery --- Transplantation --- Transfusion committees --- Transplant surgery --- Transplantation surgery

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Anemia is a frequent complication of cancer and its treatment. It produces many symptoms and significantly impairs metabolic and physiologic functions as well as patients' activity, well-being and quality of life. Life expectancy is also affected. This book, now being published in its second edition, comprehensively presents the current knowledge on anemia in cancer and its treatment with rhEPO. Future developments are also discussed. Based on updated and new chapters, including a broader spectrum of topics, outstanding international experts describe the scientific and clinical aspects of anemia in various fields of oncology and give diagnostic and therapeutic recommendations on when and how to use rhEPO. The book, considered as a standard work, will again serve as an essential source of information for radiotherapists, medical oncologists, hematologists, internists, pediatricians, surgeons, specialists in transfusion and laboratory medicine, and pharmacologists.

Medicine & Public Health. --- Oncology. --- Radiotherapy. --- Hematology. --- Surgery. --- Pharmacology/Toxicology. --- Blood Transfusion Medicine. --- Medicine. --- Toxicology. --- Blood transfusion. --- Médecine --- Toxicologie --- Radiothérapie --- Hématologie --- Cancérologie --- Chirurgie --- Anemia -- Chemotherapy. --- Antineoplastic agents. --- Cancer -- Chemotherapy -- Complications -- Chemotherapy. --- Drug Design. --- Drug Therapy. --- Recombinant erythropoietin -- Therapeutic use. --- Recombinant erythropoietin --- Anemia --- Cancer --- Colony-Stimulating Factors --- Hematologic Diseases --- Diseases --- Hemic and Lymphatic Diseases --- Hematopoietic Cell Growth Factors --- Glycoproteins --- Erythropoietin --- Neoplasms --- Cytokines --- Proteins --- Intercellular Signaling Peptides and Proteins --- Amino Acids, Peptides, and Proteins --- Chemicals and Drugs --- Peptides --- Biological Factors --- Medicine --- Health & Biological Sciences --- Oncology --- Therapeutic use --- Chemotherapy --- Complications --- Therapeutic use. --- Chemotherapy. --- Cancers --- Carcinoma --- Malignancy (Cancer) --- Malignant tumors --- Anaemia --- Epoetin --- Epogen (Trademark) --- Genetically engineered erythropoietin --- Genetic engineering --- Pharmacology. --- Tumors --- Blood --- Recombinant blood proteins --- Oncology  . --- Blood transfusion --- Blood transfusion therapy --- Hemotherapy --- Transfusion medicine --- Transfusion of blood --- Transfusion therapy --- Transfusion therapy, Blood --- Surgery --- Blood banks --- Blood groups --- Hospitals --- Transfusion-free surgery --- Chemicals --- Pharmacology --- Poisoning --- Poisons --- Surgery, Primitive --- Haematology --- Internal medicine --- Radiation therapy --- Electrotherapeutics --- Medical electronics --- Medical radiology --- Therapeutics, Physiological --- Phototherapy --- Transfusion committees --- Toxicology --- Radiological services --- Drug effects --- Medical pharmacology --- Medical sciences --- Drugs --- Pharmacy --- Physiological effect