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Medical Research for Hire
Today, more than 75 percent of pharmaceutical drug trials in the United States are being conducted in the private sector. Once the sole province of academic researchers, these important studies are now being outsourced to non-academic physicians.
According to Jill A. Fisher, this major change in the way medical research is performed is the outcome of two problems in U.S. health care: decreasing revenue for physicians and decreasing access to treatment for patients. As physicians report diminishing income due to restrictive relationships with insurers, increasing malpractice insurance premiums, and inflated overhead costs to operate private practices, they are attracted to pharmaceutical contract research for its lucrative return. Clinical trials also provide limited medical access to individuals who have no or inadequate health insurance because they offer \"free\" doctors' visits, diagnostic tests, and medications to participants. Focusing on the professional roles of those involved, as well as key research practices, Fisher assesses the risks and advantages for physicians and patients alike when pharmaceutical drug studies are used as an alternative to standard medical care.
A volume in the Critical Issues in Health and Medicine series, edited by Rima D. Apple and Janet Golden
eBook
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
Journal Article
Blockchain and clinical trial : securing patient data
\"This book aims to highlight the gaps and the transparency issues in the clinical research and trials processes and how there is a lack of information flowing back to researchers and patients involved in those trials. Lack of data transparency is an underlying theme within the clinical research world and causes issues of corruption, fraud, errors and a problem of reproducibility. Blockchain can prove to be a method to ensure a much more joined up and integrated approach to data sharing and improving patient outcomes. Surveys undertaken by creditable organisations in the healthcare industry are analysed in this book that show strong support for using blockchain technology regarding strengthening data security, interoperability and a range of beneficial use cases where mostly all respondents of the surveys believe blockchain will be important for the future of the healthcare industry. Another aspect considered in the book is the coming surge of healthcare wearables using Internet of Things (IoT) and the prediction that the current capacity of centralised networks will not cope with the demands of data storage. The benefits are great for clinical research, but will add more pressure to the transparency of clinical trials and how this is managed unless a secure mechanism like, blockchain is used\"--Publisher's description.
Book
Bayesian Adaptive Methods for Clinical Trials
Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adapti
eBook
Adaptive Designs for Clinical Trials
Investigators use adaptive trial designs to alter basic features of an ongoing trial. This approach obtains the most information possible in an unbiased way while putting the fewest patients at risk. In this review, the authors discuss selected issues in adaptive design.
Randomized clinical trials serve as the standard for clinical research and have contributed immensely to advances in patient care. Nevertheless, several shortcomings of randomized clinical trials have been noted, including the need for a large sample size and long study duration, the lack of power to evaluate efficacy overall or in important subgroups, and cost. These and other limitations have been widely acknowledged as limiting medical innovation.
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Adaptive trial design has been proposed as a means to increase the efficiency of randomized clinical trials, potentially benefiting trial participants and future patients while reducing costs and enhancing the likelihood of finding . . .
Journal Article