Novel Designs Of Early Phase Trials For Cancer Therapeutics

Download or read book Novel Designs of Early Phase Trials for Cancer Therapeutics written by Shivaani Kummar and published by Academic Press. This book was released on 2018-05-26 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials.

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Novel Designs of Early Phase Trials for Cancer Therapeutics written by Shivaani Kummar and published by Academic Press. This book was released on 2018-05-22 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. - Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics - Provides the reader with a better understanding on how to design and implement early phase oncology trials - Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development

Download or read book Dosage Forms, Formulation Developments and Regulations written by Amit Kumar Nayak and published by Elsevier. This book was released on 2023-12-09 with total page 759 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics. - Examines trends and recent technologies in dosage, formulation and regulation - Contains contributions from leading experts in academia, research, industry and regulatory agencies - Includes high-quality illustrations, flow charts and tables for easy understanding of concepts - Discusses practical examples and research case studies

Download or read book Oncology Clinical Trials written by William Kevin Kelly, DO and published by Springer Publishing Company. This book was released on 2018-03-28 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included

Download or read book Medical Geology of Africa written by Theophilus Clavell Davies and published by Elsevier. This book was released on 2024-06-14 with total page 756 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Geology of Africa explores the connection between geological materials, processes and the health of humans and animals. The book fosters an improved understanding of the ways in which the geological environment impacts the geographical distribution of health problems and how they contribute to better diagnoses and therapy. Africa's unique geoenvironmental condition gives added relevance to such studies, underlining the need for geoscience and public health students and practitioners to understand new principles and applications. Chapters in the book provide extended enquiry-based investigations and examples that employ real geochemical datasets, epidemiological records, public health statistics and visualizations. - Provides a summary of current research on Medical Geology of Africa - Identifies gaps in knowledge of the role of the geo-environment in deciphering unknown aetiologies - Assembles the most recent literature on current thematic issues, and prescribes directions of future research

Download or read book Early Phase Cancer Immunotherapy written by Sandip Pravin Patel and published by Springer. This book was released on 2017-11-03 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, a state-of-the-art review of early phase clinical trials for cancer immunotherapy, discusses biomarker selection, combinatorial strategies and their safety or toxicity, determination of Phase 2 dosing, endpoints in the setting of radiographic pseudoprogression, histology selection, and novel immunotherapeutics as they relate to early phase cancer immunotherapy.