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Economic Evaluation in Clinical Trials

Economic Evaluation in Clinical Trials PDF Author: Henry A. Glick
Publisher: OUP Oxford
ISBN: 0191508055
Category : Medical
Languages : en
Pages : 265

Book Description
It is becoming increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. The results of such analysis can affect reimbursement decisions for new medical technologies, drugs, devices or diagnostics. It can aid companies seeking to make claims about the cost-effectiveness of their product, as well as allowing early consideration of the economic value of therapies which may be important to improving initial adoption decisions. It is also vital for addressing the requirements of regulatory bodies. Economic Evaluation in Clinical Trials provides practical advice on how to conduct cost-effectiveness analyses in controlled trials of medical therapies. This new edition has been extensively rewritten and revised; topics discussed range from design issues such as the types of services that should be measured and price weights, to assessment of quality-adjusted life years. Illustrative materials, case histories and worked examples are included to encourage the reader to apply the methods discussed. These exercises are supported with datasets, programmes and solutions made available online.

Economic Evaluation in Clinical Trials

Economic Evaluation in Clinical Trials PDF Author: Henry A. Glick
Publisher: OUP Oxford
ISBN: 0191508055
Category : Medical
Languages : en
Pages : 265

Book Description
It is becoming increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. The results of such analysis can affect reimbursement decisions for new medical technologies, drugs, devices or diagnostics. It can aid companies seeking to make claims about the cost-effectiveness of their product, as well as allowing early consideration of the economic value of therapies which may be important to improving initial adoption decisions. It is also vital for addressing the requirements of regulatory bodies. Economic Evaluation in Clinical Trials provides practical advice on how to conduct cost-effectiveness analyses in controlled trials of medical therapies. This new edition has been extensively rewritten and revised; topics discussed range from design issues such as the types of services that should be measured and price weights, to assessment of quality-adjusted life years. Illustrative materials, case histories and worked examples are included to encourage the reader to apply the methods discussed. These exercises are supported with datasets, programmes and solutions made available online.

The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 030918651X
Category : Medical
Languages : en
Pages : 163

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.

Forensic Psychological Assessment in Immigration Court

Forensic Psychological Assessment in Immigration Court PDF Author: Barton Evans, III
Publisher: Routledge
ISBN: 131721921X
Category : Psychology
Languages : en
Pages : 407

Book Description
Forensic Psychological Assessment in Immigration Court is an essential specialized guide for psychologists and clinicians who work with immigrants. Immigration evaluations differ in many ways from other types of forensic assessments because of the psycholegal issues that extend beyond the individual, including family dynamics, social context, and cross-cultural concerns. Immigrants are often victims of trauma and require specialized expertise to elicit the information needed for assessment. Having spent much of their professional careers as practicing forensic psychologists, authors Evans and Hass have compiled a comprehensive text that draws on forensic psychology, psychological assessment, traumatology, family processes, and national and international political forces to present an approach for the effective and ethical practice of forensic psychological assessment in Immigration Court.

Evaluation of Juveniles' Competence to Stand Trial

Evaluation of Juveniles' Competence to Stand Trial PDF Author: Ivan Kruh
Publisher: OUP USA
ISBN: 0195323076
Category : Law
Languages : en
Pages : 296

Book Description
Forensic mental health assessment (FMHA) has grown into a specialization informed by research and professional guidelines. This series presents up-to-date information on the most important and frequently conducted forms of FMHA. The 19 topical volumes address best approaches to practice for particular types of evaluation in the criminal, civil, and juvenile/family areas. Each volume contains a thorough discussion of the relevant legal and psychological concepts, followed by a step-by-step description of the assessment process from preparing for the evaluation to writing the report and testifying in court. Volumes include the following helpful features: - Boxes that zero in on important information for use in evaluations - Tips for best practice and cautions against common pitfalls - Highlighting of relevant case law and statutes - Separate list of assessment tools for easy reference - Helpful gloassary of key terms for the particular topic In making recommendations for best practice, authors consider empirical support, legal relevance, and consistency with ethical and professional standards. These volumes offer invaluable guidance for anyone involved in conducting or using forensic evaluations.

Evaluation of Competence to Stand Trial

Evaluation of Competence to Stand Trial PDF Author: Patricia Zapf
Publisher: Oxford University Press
ISBN: 0199724164
Category : Psychology
Languages : en
Pages : 224

Book Description
Forensic mental health assessment (FMHA) has grown into a specialization informed by research and professional guidelines. This series presents up-to-date information on the most important and frequently conducted forms of FMHA. The 19 topical volumes address best approaches to practice for particular types of evaluation in the criminal, civil, and juvenile/family areas. Each volume contains a thorough discussion of the relevant legal and psychological concepts, followed by a step-by-step description of the assessment process from preparing for the evaluation to writing the report and testifying in court. Volumes include the following helpful features: - Boxes that zero in on important information for use in evaluations - Tips for best practice and cautions against common pitfalls - Highlighting of relevant case law and statutes - Separate list of assessment tools for easy reference - Helpful glossary of key terms for the particular topic In making recommendations for best practice, authors consider empirical support, legal relevance, and consistency with ethical and professional standards. These volumes offer invaluable guidance for anyone involved in conducting or using forensic evaluations.

Small Clinical Trials

Small Clinical Trials PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309171148
Category : Medical
Languages : en
Pages : 221

Book Description
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.

Recent Advances in Clinical Trial Design and Analysis

Recent Advances in Clinical Trial Design and Analysis PDF Author: Peter F. Thall
Publisher: Springer Science & Business Media
ISBN: 1461520096
Category : Medical
Languages : en
Pages : 263

Book Description
Clinical trials have two purposes -- to treat the patients in the trial, and to obtain information which increases our understanding of the disease and especially how patients respond to treatment. Statistical design provides a means to achieve both these aims, while statistical data analysis provides methods for extracting useful information from the trial data. Recent advances in statistical computing have enabled statisticians to implement very rapidly a broad array of methods which previously were either impractical or impossible. Biostatisticians are now able to provide much greater support to medical researchers working in both clinical and laboratory settings. As our collective toolkit of techniques for analyzing data has grown, it has become increasingly difficult for biostatisticians to keep up with all the developments in our own field. Recent Advances in Clinical Trial Design and Analysis brings together biostatisticians doing cutting-edge research and explains some of the more recent developments in biostatistics to clinicians and scientists who work in clinical trials.

Case Studies in Forensic Psychology

Case Studies in Forensic Psychology PDF Author: Ruth Tully
Publisher: Routledge
ISBN: 0429013132
Category : Psychology
Languages : en
Pages : 185

Book Description
Case Studies in Forensic Psychology offers the reader a unique insight into the often-hidden world of psychological assessment and intervention with people who have committed serious crimes. The book contains a breadth of forensic case studies, and each chapter details the real forensic work that psychologists do in their clinical practice in prison, psychiatric, and community settings. Assessment and therapeutic approaches used in each case study are discussed, as well as the state of the literature in each area (e.g. sexual violence risk assessment, schema therapy). Each chapter will take the reader through a variety of offender profiles, their personal background, any relevant psychiatric or psychological diagnoses, and assessments and/or treatment completed. Case studies offer valuable insight into the clinical practice and day-to-day role of a forensic psychologist, demonstrating the work undertaken that empirical research does not offer. Uniquely, Case Studies in Forensic Psychology brings together treatment models and forensic research, demonstrating how theory translates into practice and considering whether it is effective at an individual level. It is ideal for students of forensic psychology and forensic mental health, as well as practitioners at any stage of their career in this rapidly expanding field.

Psychological Testing in the Service of Disability Determination

Psychological Testing in the Service of Disability Determination PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309370930
Category : Medical
Languages : en
Pages : 233

Book Description
The United States Social Security Administration (SSA) administers two disability programs: Social Security Disability Insurance (SSDI), for disabled individuals, and their dependent family members, who have worked and contributed to the Social Security trust funds, and Supplemental Security Income (SSSI), which is a means-tested program based on income and financial assets for adults aged 65 years or older and disabled adults and children. Both programs require that claimants have a disability and meet specific medical criteria in order to qualify for benefits. SSA establishes the presence of a medically-determined impairment in individuals with mental disorders other than intellectual disability through the use of standard diagnostic criteria, which include symptoms and signs. These impairments are established largely on reports of signs and symptoms of impairment and functional limitation. Psychological Testing in the Service of Disability Determination considers the use of psychological tests in evaluating disability claims submitted to the SSA. This report critically reviews selected psychological tests, including symptom validity tests, that could contribute to SSA disability determinations. The report discusses the possible uses of such tests and their contribution to disability determinations. Psychological Testing in the Service of Disability Determination discusses testing norms, qualifications for administration of tests, administration of tests, and reporting results. The recommendations of this report will help SSA improve the consistency and accuracy of disability determination in certain cases.

Sharing Clinical Trial Data

Sharing Clinical Trial Data PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236

Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.