This volume contains a selection of chapters base on papers presented at the Fourth Seattle Symposium in Biostatistics: Clinical Trials. The symposium was held in 2010 to celebrate the 40th anniversary of the University of Washington School of Public Health and Community Medicine. It featured keynote lectures by David DeMets and Susan Ellenberg and 16 invited presentations by other prominent researchers. The papers contained in this volume encompass recent methodological advances in several important clinical trials research, such as biomarkers, meta-analyses, sequential and adaptive clinical trials, and various genetic bioinformatic techniques. This volume will be a valuable reference for researchers and practitioners in the field of clinical trials.
In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, industry, and health organizations address various aspects of the important problems in global clinical development and MRCTs. The book first provides a high-level introduction to the context, motivation, opportunities, and challenges in simultaneous global clinical development using MRCTs. It then focuses on the design, monitoring, and analysis/interpretation of MRCTs. The book concludes with an examination of the latest research topics from MRCT perspectives, such as special considerations by local health authorities, health economic evaluations, benefit-risk assessment, and medical devices. Explaining how to design, conduct, and interpret MRCTs, this book will help biostatisticians working in the late-stage clinical development of medical products. It will also be useful for statisticians and clinicians in the biopharmaceutical industry, regulatory agencies, and medical research institutes.
This volume contains a selection of papers presented at the Second Seattle Symposium in Biostatistics: Analysis of Correlated Data. The symposium was held in 2000 to celebrate the 30th anniversary of the University of Washington School of Public Health and Community Medicine. It featured keynote lectures by Norman Breslow, David Cox and Ross Prentice and 16 invited presentations by other prominent researchers. The papers contained in this volume encompass recent methodological advances in several important areas, such as longitudinal data, multivariate failure time data and genetic data, as well as innovative applications of the existing theory and methods. This volume is a valuable reference for researchers and practitioners in the field of correlated data analysis.
This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.
Methodologic issues fundamental to clinical trials
Author: Ton J. Cleophas
Publisher: Springer Science & Business Media
Despite their effectiveness in the evaluation of new pharmacological compounds, controlled clinical trials are sometimes inadequate. Using data from the literature as well as from the author's own experience with clinical trials, Human Experimentation: Methodologic Issues Fundamental to Clinical Trials addresses such inadequacies and tries to provide solutions. This work is the first to thoroughly examine these unsolved inadequacies and problems with the design and the execution of clinical trials and, more importantly, to provide solutions for these problems. It is important for anyone who is involved in clinical research: clinicians, pharmacists, biochemists, statisticians, nurses, sponsors, etc., and anyone who is involved in applying results of research to patients, i.e. physicians.
Presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. Emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references.
Proceedings of the Seventeenth Annual Detroit Cancer Symposium Detroit, Michigan — April 12–13, 1984
Author: L.O. Baker
Publisher: Springer Science & Business Media
This year notes two major changes in the annual Detroit Cancer Symposium. The first is our intention of selecting top ics of broad interest to the cancer community and examining the subject from both a basic laboratory and clinical viewpoint. In this way, the importance of both elements of cancer research are noted and the interplay between them emphasized. Further, we believe that Symposia such as this act to stimulate the basic scientist and clinician to continue their studies with the know ledge of the impact that each has upon the other and the nec essary cooperation required to solve the cancer problem. The second change is the publication of this Symposium. The pre vious sixteen were not committed to manuscript form. Given the change in format and intent of the series, we believe that this and subsequent volumes will make important contributions to the cancer literature. The topic of "Biology and Therapy of Acute Leukemia" was chosen for the first Symposium because of its historical signif icance in cancer chemotherapy. The therapeutic rationale for human leukemia is the result of understanding the basic tumor biology largely derived from transplantable leukemias in exper imental animals. It is through these models, as discussed by Dr. Fred Valeriote, that we learned the cellular kinetics of leukemia, the antileukemic effects of new agents and the ef fect of growth perturbation by various chemotherapeutic agents and their combinations.