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"Clinical Trials as Topic - history"
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Outcomes and endpoints in trials of cancer treatment: the past, present, and future
Cancer treatment should allow patients to live better or longer lives, and ideally, both. Trial endpoints should show clinically meaningful improvements in patient survival or quality of life. Alternative endpoints such as progression-free survival, disease-free survival, and objective response rate have been used to identify benefit earlier, but their true validity as surrogate endpoints is controversial. In this Review we discuss the measurement, assessment, and benefits and limitations of trial endpoints in use for cancer treatment. Many stakeholders are affected, including regulatory agencies, industry partners, clinicians, and most importantly, patients. In an accompanying Review, reflections from individual stakeholders are incorporated into a discussion of what the future holds for clinical trial endpoints and design.
Journal Article
Patients and Doctors — The Evolution of a Relationship
The relationship between patients and doctors is at the core of medical ethics, anchoring many important debates in the field. Over the past several decades, this relationship has evolved along three axes — as it is defined in clinical care, research, and society.
The relationship between patients and doctors is at the core of medical ethics, serving as an anchor for many of the most important debates in the field. Over the past several decades, this relationship has evolved along three interrelated axes — as it is defined in clinical care, research, and society. Many of the pivotal discussions of these issues have appeared in the pages of the
Journal
(see Key NEJM Articles on Medical Ethics).
Clinical Care
The relationship between patients and doctors in the clinical realm has historically been framed in terms of benevolent paternalism. Until about 1960, most codes of medical ethics relied heavily . . .
Journal Article
A Personal History of the MASTER Trial and Its Link to the Clinical Trials Network of the Australian and New Zealand College of Anaesthetists
The aim of this paper is to link the history of the Multicentre Australian Study of Epidural Anaesthesia in high risk surgery, the MASTER Trial, the first National Health and Medical Research Council (NHMRC) funded multicentre randomised clinical trial In Australia led by anaesthetist researchers, and the decision of The Australian and New Zealand College of Anaesthetists (ANZCA) to establish a clinical trials network, in 2003, to the success of contemporary researchers in Australia and New Zealand in anaesthesia and perioperative medicine.
Journal Article
The placebo response in clinical trials: more questions than answers
Meta-analyses and re-analyses of trial data have not been able to answer some of the essential questions that would allow prediction of placebo responses in clinical trials. We will confront these questions with current empirical evidence. The most important question asks whether the placebo response rates in the drug arm and in the placebo arm are equal. This ‘additive model’ is a general assumption in almost all placebo-controlled drug trials but has rarely been tested. Secondly, we would like to address whether the placebo response is a function of the likelihood of receiving drug/placebo. Evidence suggests that the number of study arms in a trial may determine the size of the placebo and the drug response. Thirdly, we ask what the size of the placebo response is in ‘comparator’ studies with a direct comparison of a (novel) drug against another drug. Meta-analytic and experimental evidence suggests that comparator studies may produce higher placebo response rates when compared with placebo-controlled trials. Finally, we address the placebo response rate outside the laboratory and outside of trials in clinical routine. This question poses a serious challenge whether the drug response in trials can be taken as evidence of drug effects in clinical routine.
Journal Article
Clinical Study Reports—a systematic review with thematic synthesis: Part 1. History, contents and structure, definitions, and terminology
Background
Clinical study reports (CSRs) are standardized full reports of the protocols, results, and other pertinent details of clinical studies that are typically submitted by pharmaceutical companies to regulatory authorities, as part of the drug approval process. Their recommended contents and structure were described in 1995 in a document of the International Conference on Harmonisation, ICH E3, although companies can choose how to present the data. Until 2015, such reports were not readily available to the public, but since then some regulatory authorities have made them available, as have some pharmaceutical companies, albeit often in abbreviated or redacted versions. The apparent benefits of pharmacological interventions are not as impressive when they are calculated using data from clinical study reports compared with published trial reports, and more information emerges about harms the interventions can cause.
Results
Our methods are described in Part 2 of this systematic review with thematic synthesis, in which we have summarized the uses of CSRs, as described in 349 publications of various sorts, including analyses of clinical trials, data analyses, commentaries, and official documents. We have specifically concentrated on how CSRs affect assessments of benefits, harms, and the benefit-to-harm balance, and other factors that affect it. In Part 1, we discuss the history of the development of CSRs, their contents and structure, definitions of CSRs and qualifying terms, and relevant terminology (including the availability of CSRs, data sharing systems, and transparency and confidentiality).
Conclusions
Our conclusions are listed in Part 2 of this review.
Journal Article
Patient-reported outcomes in Canadian cancer research
These days, medical researchers may take the inclusion of patient perspectives in clinical science for granted, but it was the result of a long, multifaceted process that unfolded over several decades. Here, Razumenko explores aspect of the incorporation of patient perspectives into clinical research in Canada--the introduction of patient-reported outcome measures to cancer trials.
Journal Article
Failing the Public Health — Rofecoxib, Merck, and the FDA
On May 21, 1999, Merck was granted approval by the Food and Drug Administration (FDA) to market rofecoxib (Vioxx). On September 30, 2004, after more than 80 million patients had taken this medicine and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes. This represents the largest prescription-drug withdrawal in history, but had the many warning signs along the way been heeded, such a debacle could have been prevented.
Neither of the two major forces in this five-and-a-half-year affair — neither Merck nor the FDA — fulfilled its . . .
Journal Article