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Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout
In radiation oncology as in many other specialties clinical trials are essential to investigate new therapy approaches. Usually, preparation for a prospective clinical trial is extremely time consuming until ethics approval is obtained. To test a new treatment usually many years pass before it can be implemented in the routine care. During that time, already new interventions emerge, new drugs appear on the market, technical & physical innovations are being implemented, novel biology driven concepts are translated into clinical approaches while we are still investigating the ones from years ago. Another problem is associated with molecular diagnostics and the growing amount of tumor specific biomarkers which allows for a better stratification of patient subgroups. On the other side, this may result in a much longer time for patient recruiting and consequently in larger multicenter trials. Moreover, all of the relevant data must be readily available for treatment decision making, treatment as well as follow-up, and ultimately for trial evaluation. This challenges even more for agreed standards in data acquisition, quality and management. How could we change the way currently clinical trials are performed in a way they are safe and ethically justifiable and speed up the initiation process, so we can provide new and better treatments faster for our patients? Further, while we rely on various quantitative information handling distributed, large heterogeneous amounts of data efficiently is very important. Thus data management becomes a strong focus. A good infrastructure helps to plan, tailor and conduct clinical trials in a way they are easy and quickly analyzable. In this research topic we want to discuss new ideas for intelligent trial designs and concepts for data management.
A compendium of cutting-edge statistical approaches to solving problems in clinical oncology, Handbook of Statistics in Clinical Oncology, Second Edition focuses on clinical trials in phases I, II, and III, proteomic and genomic studies, complementary outcomes and exploratory methods. Cancer Forum called the first edition a
Decision Making in Radiation Oncology is a reference book designed to enable radiation oncologists, including those in training, to make diagnostic and treatment decisions effectively and efficiently. The design is based on the belief that “a picture is worth a thousand words.” Knowledge is conveyed through an illustrative approach using algorithms, schemas, graphics, and tables. Detailed guidelines are provided for multidisciplinary cancer management and radiation therapy techniques. In addition to the attention-riveting algorithms for diagnosis and treatment, strategies for the management of disease at individual stages are detailed for all the commonly diagnosed malignancies. Clinical trials that have yielded “gold standard” treatment and their results are documented in the schemas. Moreover, radiation techniques, including treatment planning and delivery, are presented in an illustrative way. This groundbreaking publication is an essential tool for physicians in their daily clinical practice.
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.
The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.
Since the dawn of civilization, humans have feared the unknown risks associated with the use of new natural herbs or other natural medications to cure their pain, aches and illnesses. In the ancient Indian Ayurvedic Medicine which is over 4000 years old, the Visha (poison) Tantra (wisdom) was developed as a discipline of medicine encompassing Toxicology and Preventive Medicines. Visha Tantra included the study of various toxic herbs and animals and their antidotes as well as the biomarkers of toxic effects. In the Visha Tantra and the practice of Ayurvedic medicine, there have been objective descriptions of the changes in colour and amount of urine, changes in the colour of nails, skin and eyes, breathing patterns, gastrointestinal disturbances, and precautionary measures to prevent adverse effects as biomarkers of toxicity associated with the use of herbal medicines and certain foods. The adverse effects are an inevitable outcome of the environmental and industrial chemicals and pharmaceuticals; however, efforts are ongoing to prevent unexpected life-threatening toxicities and/or irreversible organ damage.The search for non-invasive biomarkers that can be objectively linked to adverse effects associated with manmade synthetic chemicals, including pharmaceuticals and environmental pollutants, is becoming an important priority for academicians, federal agencies, pharmaceutical and industrial companies. This publication is devoted to toxicity biomarkers of target organs of toxicity and molecular epidemiology. It provides a comprehensive review of a wide spectrum of biomarkers, including molecular epidemiology biomarkers of aflatoxin and hepatitis B virus induced hepatocarcinogenesis, cytokines as the biomarkers of hepatocellular injury, drug-induced vascular injury, nephrotoxicity and reproductive toxicity biomarkers.
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
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.