A Continuing Trial Of Treatment

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
Publisher : National Academies Press
Page : 163 pages
File Size : 45,9 Mb
Release : 2010-12-21
Category : Medical
ISBN : 9780309186513

Get Book

The Prevention and Treatment of Missing Data in Clinical Trials by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Pdf

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 : Stephen Frankel,Gilbert Lewis
Publisher : Springer Science & Business Media
Page : 336 pages
File Size : 54,9 Mb
Release : 2012-12-06
Category : Social Science
ISBN : 9789400927315

Get Book

A Continuing Trial of Treatment by Stephen Frankel,Gilbert Lewis Pdf

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Publisher : National Academies Press
Page : 222 pages
File Size : 41,8 Mb
Release : 2001-01-01
Category : Medical
ISBN : 0309171148

Get Book

Small Clinical Trials by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials Pdf

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.

Author : Institute of Medicine,Committee to Review the Fialuridine (FIAU/FIAC) Clinical Trials
Publisher : National Academies Press
Page : 279 pages
File Size : 53,6 Mb
Release : 1995-03-14
Category : Medical
ISBN : 9780309176613

Get Book

Review of the Fialuridine (FIAU) Clinical Trials by Institute of Medicine,Committee to Review the Fialuridine (FIAU/FIAC) Clinical Trials Pdf

In June 1993 a clinical trial of fialuridine (FIAU), a promising new medication for hepatitis B, was abruptly terminated when one of the 15 out-patients participating in the National Institutes of Health (NIH) study was suddenly hospitalized with liver failure. Although all the remaining patients were contacted and told to stop taking their medication, six more subsequently developed severe toxicity. Five patients died, and two others were probably saved from death only by having liver transplants. In response to a request from the Secretary of the Department of Health and Human Services, the IOM committee has analyzed the FIAU clinical trials, making recommendations for additional safeguards for the conduct of future clinical trials. This evaluation included the review of documents pertaining to investigational new drug submissions, protocols and consent forms from other clinical trials, as well as information available from other clinical and preclinical experience with compounds related to FIAU and its parent drug, fiacitibine (FIAC), which is metabolized to FIAU. The committee does not seek to affix responsibility for the adverse outcome of this NIH trial, but instead focuses on whether any rules or procedures governing the clinical trials process itself need to be changed, and if so, what burdens or costs such changes might place on future clinical trials.

Author : Timothy A. Yap,Jordi Rodon,David S. Hong
Publisher : Springer Nature
Page : 352 pages
File Size : 55,8 Mb
Release : 2020-09-16
Category : Medical
ISBN : 9783030476823

Get Book

Phase I Oncology Drug Development by Timothy A. Yap,Jordi Rodon,David S. Hong Pdf

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 : Institute of Medicine,Committee on Routine Patient Care Costs in Clinical Trials for Medicare Beneficiaries
Publisher : National Academies Press
Page : 86 pages
File Size : 43,8 Mb
Release : 2000-03-17
Category : Medical
ISBN : 9780309068888

Get Book

Extending Medicare Reimbursement in Clinical Trials by Institute of Medicine,Committee on Routine Patient Care Costs in Clinical Trials for Medicare Beneficiaries Pdf

Increasingly over the past five years, uncertainty about reimbursement for routine patient care has been suspected as contributing to problems enrolling people in clinical trials. Clinical trial investigators cannot guarantee that Medicare will pay for the care required, and they must disclose this uncertainty to potential participants during the informed consent process. Since Medicare does not routinely "preauthorize" care (as do many commercial insurers) the uncertainty cannot be dispelled in advance. Thus, patients considering whether to enter trials must assume that they may have to pay bills that Medicare rejects simply because they have enrolled in the trial. This report recommends an explicit policy for reimbursement of routine patient care costs in clinical trials. It further recommends that HCFA provide additional support for selected clinical trials, and that the government support the establishment of a national clinical trials registry. These policies (1) should assure that beneficiaries would not be denied coverage merely because they have volunteered to participate in a clinical trial; and (2) would not impose excessive administrative burdens on HCFA, its fiscal intermediaries and carriers, or investigators, providers, or participants in clinical trials. Explicit rules would have the added benefit of increasing the uniformity of reimbursement decisions made by Medicare fiscal intermediaries and carriers in different parts of the country. Greater uniformity would, in turn, decrease the uncertainty about reimbursement when providers and patients embark on a clinical trial.

Author : Chinese University of Hong Kong,Chinese University of Hong Kong. Clinical Trials Centre,Washington, DC. Association for the Accreditation of Human research Protection Programs, Inc
Publisher : Unknown
Page : 153 pages
File Size : 51,9 Mb
Release : 2010
Category : Clinical trials
ISBN : 9881904110

Get Book

Reviewing Clinical Trials by Chinese University of Hong Kong,Chinese University of Hong Kong. Clinical Trials Centre,Washington, DC. Association for the Accreditation of Human research Protection Programs, Inc Pdf

The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.

Author : Edward J Larson
Publisher : Basic Books
Page : 352 pages
File Size : 50,5 Mb
Release : 2020-06-16
Category : Law
ISBN : 9781541646025

Get Book

Summer for the Gods by Edward J Larson Pdf

The Pulitzer Prize-winning history of the Scopes Trial and the battle over evolution and creation in America's schools In the summer of 1925, the sleepy hamlet of Dayton, Tennessee, became the setting for one of the twentieth century's most contentious courtroom dramas, pitting William Jennings Bryan and the anti-Darwinists against a teacher named John Scopes, represented by Clarence Darrow and the ACLU, in a famous debate over science, religion, and their place in public education. That trial marked the start of a battle that continues to this day-in cities and states throughout the country. Edward Larson's classic Summer for the Gods -- winner of the Pulitzer Prize in History -- is the single most authoritative account of this pivotal event. An afterword assesses the state of the battle between creationism and evolution, and points the way to how it might potentially be resolved.

Author : Simon S. Lo,Bin S. Teh,Jiade J. Lu,Tracey E. Schefter
Publisher : Springer Science & Business Media
Page : 433 pages
File Size : 51,7 Mb
Release : 2012-08-28
Category : Medical
ISBN : 9783642256042

Get Book

Stereotactic Body Radiation Therapy by Simon S. Lo,Bin S. Teh,Jiade J. Lu,Tracey E. Schefter Pdf

Stereotactic body radiation therapy (SBRT) has emerged as an important innovative treatment for various primary and metastatic cancers. This book provides a comprehensive and up-to-date account of the physical/technological, biological, and clinical aspects of SBRT. It will serve as a detailed resource for this rapidly developing treatment modality. The organ sites covered include lung, liver, spine, pancreas, prostate, adrenal, head and neck, and female reproductive tract. Retrospective studies and prospective clinical trials on SBRT for various organ sites from around the world are examined, and toxicities and normal tissue constraints are discussed. This book features unique insights from world-renowned experts in SBRT from North America, Asia, and Europe. It will be necessary reading for radiation oncologists, radiation oncology residents and fellows, medical physicists, medical physics residents, medical oncologists, surgical oncologists, and cancer scientists.

Author : American Psychiatric Association
Publisher : American Psychiatric Pub
Page : 226 pages
File Size : 49,5 Mb
Release : 2018-01-11
Category : Medical
ISBN : 9780890426821

Get Book

The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder by American Psychiatric Association Pdf

The guideline focuses specifically on evidence-based pharmacological treatments for AUD in outpatient settings and includes additional information on assessment and treatment planning, which are an integral part of using pharmacotherapy to treat AUD.

Author : Hans-Christoph Diener,Marcia Wilkinson
Publisher : Springer Science & Business Media
Page : 174 pages
File Size : 46,5 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9783642733277

Get Book

Drug-Induced Headache by Hans-Christoph Diener,Marcia Wilkinson Pdf

M. WILKINSON Patients with frequent or daily headaches pose a very difficult problem for the physician who has to treat them, particularly as many patients think that there should be a medicine or medicines which give them instant relief. In the search for the compound which would meet this very natural desire, many drugs have been manufactured and the temptation for the physician is either to increase the dose of a drug which seems to be, at any rate, partially effective, or to add one or more drugs to those which the patient is already taking. Although there have been some references to the dangers of overdosage of drugs for migraine in the past, it was not until relatively recently that it was recognized that drugs given for the relief of headache, if taken injudiciously, may themselves cause headache. The first drugs to be implicated in this way were ergotamine and phenazone. In the case of ergotamine tartrate, the dangers of ergotism were well known as this was a disorder which had been known and written about for many years. In the treatment of headache, fully blown ergotism is rare and in recent years has usually been due to self-medication in doses much greater than those prescribed although there are a few recorded cases where toxic amounts have been given.

Author : Denise M. Sloan,Brian P. Marx
Publisher : American Psychological Association (APA)
Page : 115 pages
File Size : 51,8 Mb
Release : 2019
Category : Psychology
ISBN : 1433830124

Get Book

Written Exposure Therapy for PTSD by Denise M. Sloan,Brian P. Marx Pdf

This treatment manual provides mental health professionals with instructions for conducting written exposure therapy, a brief and accessible trauma intervention that is effective at reducing PTSD symptoms.

Author : Canada
Publisher : Unknown
Page : 0 pages
File Size : 45,8 Mb
Release : 1996
Category : Civil rights
ISBN : OCLC:49089791

Get Book

The Constitution Act, 1982 by Canada Pdf

Author : Tomasz M. Beer,Larry Axmaker
Publisher : Diamedica
Page : 0 pages
File Size : 52,6 Mb
Release : 2012
Category : Cancer
ISBN : 098232197X

Get Book

Cancer Clinical Trials by Tomasz M. Beer,Larry Axmaker Pdf

A readable guide for anyone who is considering therapeutic options in addition to standard cancer therapy. The book seeks to share knowledge about cancer clinical trials with people living with cancer, their families and loved ones.

Author : Rosanne Cecil
Publisher : Routledge
Page : 226 pages
File Size : 46,5 Mb
Release : 2020-08-26
Category : Social Science
ISBN : 9781000325638

Get Book

Anthropology of Pregnancy Loss by Rosanne Cecil Pdf

How much influence does culture have on a mother's reactions to pregnancy loss? At what stage is a fetus attributed with human status? How does this affect the mother's reactions to the loss of a baby?Contemporary, historical and oral-history accounts from regions as diverse as rural North India, urban America, South Africa and Northern Ireland, provide a fascinating insight into the experience and management of miscarriage across a number of different cultures. The authors explore how the social, technological and medical context in which miscarriages occur can affect the ways in which women experience such an event. In the West, advances in medical technology, a low infant-mortality rate and a low birth rate have raised expectations as to the successful outcome of each pregnancy. In addition, the early confirmation of pregnancy makes consequent pregnancy loss -- which might have gone unnoticed or unconfirmed in the past -- all the more difficult for mothers in the West. Yet, mourning rituals and behaviour at a pregnancy loss, which may be elaborate in some societies, are generally considered to be inappropriate in many Western societies. Differing social beliefs regarding the causes of miscarriage, preventative measures and curative treatments are also examined. Medical anthropologists, sociologists and health professionals will all find this book fascinating reading.