Randomized Phase II Cancer Clinical Trials

Randomized Phase II Cancer Clinical Trials PDF

Author: Sin-Ho Jung

Publisher: CRC Press

Published: 2013-05-02

Total Pages: 236

ISBN-13: 1439871868

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In cancer research, a traditional phase II trial is designed as a single-arm trial that compares the experimental therapy to a historical control. This simple trial design has led to several adverse issues, including increased false positivity of phase II trial results and negative phase III trials. To rectify these problems, oncologists and biosta

The Comprehensive Guide To Clinical Research

The Comprehensive Guide To Clinical Research PDF

Author: Chris Sauber

Publisher: Independently Published

Published: 2019-04-21

Total Pages: 218

ISBN-13: 9781090349521

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Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps

Small Clinical Trials

Small Clinical Trials PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2001-01-01

Total Pages: 221

ISBN-13: 0309171148

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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.

Phase I Oncology Drug Development

Phase I Oncology Drug Development PDF

Author: Timothy A. Yap

Publisher: Springer Nature

Published: 2020-09-16

Total Pages: 352

ISBN-13: 3030476820

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This book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials. The book covers strategies to accelerate the development of novel antitumor compounds from the laboratory to clinical trials and beyond through the use of innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies. The reader will learn about all aspects of modern phase I trial designs, including the incorporation of precision medicine strategies, and approaches for rational patient allocation to novel anticancer therapies. Circulating biomarkers to assess mechanisms of response and resistance are changing the way we are assessing patient selection and are also covered in this book. The development of the different classes of antitumor agents are discussed, including chemotherapy, molecularly targeted agents, immunotherapies and also radiotherapy. The authors also discuss the lessons that the oncology field has learnt from the development of hematology-oncology drugs and how such strategies can be carried over into therapies for solid tumors. There is a dedicated chapter that covers the specialized statistical approaches necessary for phase I trial designs, including novel Bayesian strategies for dose escalation. This volume is designed to help clinicians better understand phase I clinical trials, but would also be of use to translational researchers (MDs and PhDs), and drug developers from academia and industry interested in cancer drug development. It could also be of use to phase I trial study coordinators, oncology nurses and advanced practice providers. Other health professionals interested in the treatment of cancer will also find this book of great value.

Artemisinin-Based and Other Antimalarials

Artemisinin-Based and Other Antimalarials PDF

Author: Guoqiao Li

Publisher: Academic Press

Published: 2017-11-28

Total Pages: 736

ISBN-13: 0128132116

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Artemisinin-Based and Other Antimalarials: Detailed Account of Studies by Chinese Scientists Who Discovered and Developed Them provides a historical and scientific background of the discovery and development of artemisinin, artemisinin derivatives, combination drugs and related chemicals. It is a historical document, a scientific treatise, and a fascinating description of innovative research on new drug development that is carried out under extremely difficult conditions. The book also includes detailed experiments, physical-chemical procedures, practical methodologies and clinical trials. It is a valuable reference for students and researchers in the fields of scientific history, medicine, pharmaceutical science, chemistry, pharmacology and toxicology. Presents details of all stages of drug development, including in vitro experiment, animal exploratory studies, animal tests for toxicity, safety and efficacy followed by stages I, II, III and IV, safety and efficacy in human volunteers and patients with malaria Provides many physical-chemical laboratory procedures, such as NMR, MS, HPLC and X-ray diffraction used in drug development Includes practical methodology of clinical trials from many research centers and countries to demonstrate the importance of this discovery

Bayesian Designs for Phase I-II Clinical Trials

Bayesian Designs for Phase I-II Clinical Trials PDF

Author: Ying Yuan

Publisher: CRC Press

Published: 2017-12-19

Total Pages: 233

ISBN-13: 1315354225

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Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.

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