Clinical Research Methodology and Evidence - Based Medicine

Clinical Research Methodology and Evidence - Based Medicine
Author: Ajit N Babu
Publisher: Wolters kluwer india Pvt Ltd
Total Pages: 205
Release: 2014-01-01
Genre: Medical
ISBN: 9351293203

Research methodology is a discipline concerned with the scientific conception, design, implementation and analysis of research. Evidence-based medicine (EBM) is an approach for evaluating and applying medical knowledge, particularly that derived from original research, in the care of individual patients. This book strives to give the reader a sound introduction to these related subjects which form a continuum. In this revised and expanded second edition, existing areas have been treated in greater depth, more examples provided and a number of fresh topics added. New chapters now address the finer points of survey design, provide tips on effective scientific writing for publication and outline the process of drug discovery from product conception to marketing. With these modifications, the book provides a more holistic picture of EBM and clinical research, appealing to a broader audience of medical students, practicing physicians, nursing staff, new investigators and researchers in CRO as well as the pharmaceutical industry.

Pearls and Tricks in Pediatric Surgery

Pearls and Tricks in Pediatric Surgery
Author: Martin Lacher
Publisher: Springer Nature
Total Pages: 522
Release: 2020-10-29
Genre: Medical
ISBN: 3030510670

Providing core information on pediatric surgery, this book serves as a supplement to standard pediatric surgical textbooks. It offers pearls of wisdom that will help those who participate in pediatric surgical care, as well as to provide state-of-the-art insights based on physiological principles, literature reviews, and clinical experience. This book is an ideal tool to help readers prepare for questions they will be asked on ward rounds, in the OR, or in oral exams. The depth of exploration is intended for medical students, residents in pediatrics and pediatric surgery, pediatric surgical trainees, pediatric nurse practitioners, primary care pediatricians, and family practitioners.

Evidence-based Medicine

Evidence-based Medicine
Author: Sharon E. Straus
Publisher: Elsevier Masson
Total Pages: 306
Release: 2005
Genre: Medical
ISBN: 9782842997731

The accompanying CD-ROM contains clinical examples, critical appraisals and background papers.

Foundations of Clinical Research

Foundations of Clinical Research
Author: Leslie Gross Portney
Publisher:
Total Pages: 0
Release: 2015
Genre: Biomedical Research
ISBN: 9780803646575

Draw upon the foundations necessary for finding and interpreting research evidence across all healthcare professions. Revised to reflect the most current changes in the field of clinical research in rehabilitation and medicine, you'll find a growing emphasis on evidence-based practice (EBP) as well as new vocabulary that is being integrated into research and practice across disciplines.

Myocardial Preservation

Myocardial Preservation
Author: Dennis V. Cokkinos
Publisher: Springer
Total Pages: 406
Release: 2019-01-28
Genre: Medical
ISBN: 3319981862

This timely book reveals an integrated approach to myocardial preservation focusing on translational research and clinical applications. Chapters cover both the mechanisms of heart failure in addition to therapeutic considerations, including forms of cardiac cell death, cardiac remodelling and cardiac regeneration. Potential future research directions are also proposed, enabling the reader to gain a broad in-depth understanding of the topic. Myocardial Preservation: Translational Research and Clinical Application presents a thorough review of myocardial preservation. Its comprehensive approach provides a valuable reference for cardiology researchers and practising and trainee cardiologists seeking new insight to the topic.

Fundamentals of Evidence Based Medicine

Fundamentals of Evidence Based Medicine
Author: Kameshwar Prasad
Publisher: Springer Science & Business Media
Total Pages: 165
Release: 2013-08-16
Genre: Medical
ISBN: 8132208315

This is a basic book on evidence-based medicine (EBM). It starts with an introduction to the topic. It outlines the relationship between EBM and research and quality of care. Then It goes on to cover the most commonly used modules of EBM, i.e. therapy, diagnosis, prognosis and meta-analysis. Each module starts with an introduction to fundamental concepts, and description of the related research process, and then follows the critical appraisal of related type of research artcle. At the end, it covers the different systems of grading of level of evidence and strength of recommendations. The book also has three examples of critical appraisal on diagnosis, therapy, and meta-analysis.​

Sharing Clinical Trial Data

Sharing Clinical Trial Data
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 236
Release: 2015-04-20
Genre: Medical
ISBN: 0309316324

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.

The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials
Author: National Research Council
Publisher: National Academies Press
Total Pages: 163
Release: 2010-12-21
Genre: Medical
ISBN: 030918651X

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.

Randomised Controlled Trials

Randomised Controlled Trials
Author: Alejandro R. Jadad
Publisher: Wiley-Blackwell
Total Pages: 123
Release: 1998
Genre: Medical
ISBN: 9780727912084

The contributors to this study present a balanced view of the strengths and weaknesses of randomised controlled trials in the medical setting. They cover all the essential issues without using statistics.

Small Clinical Trials

Small Clinical Trials
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 221
Release: 2001-01-01
Genre: Medical
ISBN: 0309171148

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.