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Author: National Research Council
Publisher: National Academies Press
ISBN: 030918651X
Category : Medical
Languages : en
Pages : 163
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Book Description
Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Author: National Research Council
Publisher: National Academies Press
ISBN: 030918651X
Category : Medical
Languages : en
Pages : 163
Get Book Here
Book Description
Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241547685
Category : Medical
Languages : en
Pages : 62
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Book Description
This guidance is an update of WHO global influenza preparedness plan: the role of WHO and recommendations for national measures before and during pandemics, published March 2005 (WHO/CDS/CSR/GIP/2005.5).
Author: Timothy A. Yap
Publisher: Springer Nature
ISBN: 3030476820
Category : Medical
Languages : en
Pages : 352
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Book Description
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.
Author: U. Metzger
Publisher: Springer Science & Business Media
ISBN: 3642824323
Category : Medical
Languages : en
Pages : 170
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Book Description
One reason for failure to cure solid tumors by surgery appears to be the impossibility of controlling metastases that are present but latent at the time of operation. This failure is a common clinical experience with aggressive neoplasms. but it is not always appreciated in tumors with longer survival times. e. g .• breast and colon cancer. In addition. recent evidence indicates that after resection of a primary tumor micrometas tases from it might be enhanced by suppression of immune and reticu loendothelial functions of the host. Other factors, such as increase of coagulability and stress in the perioperative period, can also promote tumor growth. The development of new metastases might be facilitated by cells forced into the circulation during operative manipulations. Such events could be important for the outcome of treatment and it is suggested that preventive measures should be directed to this systemic component of solid tumors. Radical surgery can reduce the number of tumor cells to a subclinical 3 6 stage (10 to 10 cells) in which chemotherapy might be more effective than in advanced stages. Chemotherapy, on the other hand, might aggravate the surgical morbidity by influencing the wound healing pro cess, by decreasing the immune response, and/or by toxicity to the bone marrow and to the gastrointestinal tract, for example.
Author: Alex Irvine
Publisher: Little, Brown Books for Young Readers
ISBN: 0316314099
Category : Juvenile Fiction
Languages : en
Pages : 143
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Book Description
Marvel's Captain America: Civil War pits hero against hero! Captain America and Iron Man lead two teams of heroes in a clash that will change the course of the Marvel Cinematic Universe. Following the record-breaking success of Marvel's Captain America: The Winter Soldier, the First Avenger will jump into his next big screen solo adventure on May 6, 2016 in Marvel's Captain America: Civil War! Inspired by a classic Marvel comics storyline, the third cinematic Captain America adventure will put Cap against his fellow Avenger, Iron Man. Chris Evans will reprise his role as Captain America, joined by Robert Downey Jr. as Iron Man and Chadwick Boseman (42, Get On Up) as the Black Panther, a character who will make his big screen debut in the film.
Author:
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Languages : en
Pages : 1362
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Book Description
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Languages : en
Pages : 312
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Book Description
Author: Donald Irvin Mount
Publisher:
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Category : Effluent quality
Languages : en
Pages : 42
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Book Description
Author: United States. Congress. Joint Committee on Atomic Energy
Publisher:
ISBN:
Category : Nuclear power plants
Languages : en
Pages : 568
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Book Description
Author: Shivaani Kummar
Publisher: Academic Press
ISBN: 0128125705
Category : Medical
Languages : en
Pages : 235
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Book Description
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
