Search results for "Topic"

Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use

2015

During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and those approaching marketing authorization are still few. One major area of challenge is the manufacturing and quality development of these complex products, for which significant manipulation of cells might be required. While the paradigms of quality, safety and efficacy must apply also to these innovative products, their demonstration may be demanding. Demonstration of comparability between production processes and batches may be difficult for cell-based medicinal products. Thus, the development …

The use of Endurant stent-graft for abdominal aortic aneurysm: the story about extension of instruction for use with persistent good results of stent…

2012

The Endurant stent-graft (Medtronic, Inc., Minneapolis, MN, USA) is a latest generation device for the treatment of abdominal aortic aneurysm. The idea behind designing such a graft came from the intention to broad the instruction for use (IFU) and to enable it to treat more challenging anatomy including the 10mm neck lengths, and more severe suprarenal and infrarenal angulations. Endurant stent-graft has active fixation through suprarenal stent with anchoring pins to provide migration resistance, optimized heights of stents and spacing between them for improved flexibility and conformability, low-profile delivery system with hydrophilic coating and controlled simple deployment mechanism. S…

The protection of the person in medical research in the Spanish law.

2002

AbstractNo Abstract

Factors influencing inclusion in digestive cancer clinical trials: A population-based study

2015

Inclusion in a randomized therapeutic trial represents an optimal therapeutic strategy.To determine the influence of demographic characteristics and deprivation on the enrolment of patients in digestive cancer clinical trials.Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer Registry. According to a balancing score, the 136 patients included in a clinical trial were matched with 272 patients who met the eligibility criteria for trials. Deprivation was measured by the ecological European deprivation index. A conditional multivariate logistic regression was performed.Patients aged over 75 years were significantly less likely to be included in clinical trials …

Psychotropic Drugs in the Management of Chronic Pain Syndromes

1993

Psychotropic drugs have been integrated into the management of chronic pain syndromes for more than 30 years. Numerous open and controlled studies have taken place evaluating especially the antinociceptive efficacy of antidepressive drugs. This survey comprises the results of clinical reports, open clinical studies, placebo-controlled studies, and comparative studies of different substances. It will be shown that antidepressants are by far the best evaluated psychopharmacological substances, showing superiority against placebo in 70% of a total of 67 placebo-controlled studies. The synopsis of controlled comparison studies of different antidepressants tends to demonstrate a superiority of c…

Specific recommendations for PROs and HRQoL assessment in allergic rhinitis and/or asthma: a GA(2)LEN taskforce position paper

2010

The GA(2)LEN taskforce on Patient-Reported Outcomes (PROs) and Health-Related Quality of Life (HRQoL) published in 2009 a position paper concerning PROS and HRQoL assessment in clinical trials on allergy. Because of the specificity of this topic in asthma and rhinitis, specific recommendations are needed. The aim of this position paper is to define PROs and their meaning in asthma and rhinitis research, explore the available tools to provide criteria for a proper choice, identify patient-related factor which could influence PROs assessment, define specific recommendations for assessment, analysis and results spreading, underline the unexplored areas and unmet needs. PROs assessment is gaini…

Fighting the bushfire in HCC trials

2011

Adaptive trial design: a general methodology for censored time to event data.

2008

Adaptive designs allow a clinical trial design to be changed according to interim findings without inflating type I error. The Inverse Normal method can be considered as an adaptive generalization of classical group sequential designs. The use of the Inverse Normal method for censored survival data was demonstrated only for the logrank statistic. However, the logrank statistic is inefficient in the presence of nuisance covariates affecting survival. We demonstrate, how the Inverse Normal method can be applied to Cox regression analysis. The required independence between test statistics of the different stages of the trial can be obtained by two different approaches. One is using the indepen…

Thoughts of a reviewer

1990

Oral Glycoprotein IIb/IIa Antagonists for Unstable Angina — Is There Still a Chance for the Oral Substances?

2001

The intravenous glycoprotein IIb/IIIa antagonists abciximab, tirofiban and eptifibatide are well accepted for the therapy of patients with unstable angina and/or as concomitant medication during coronary interventions. Despite the fact that these drugs are not used in all patients presenting with unstable angina during coronary interventions, the scientific evidence is overwhelming including the substantial reduction in mortality 3 years after utilisation of abciximab for coronary interventions in patients with unstable angina. In addition to these two indications, intravenous glycoprotein IIb/IIIa antagonists are currently being investigated for use in patients undergoing carotid artery in…