PubMed Journals Articles About "Hold Workshop Structured Benefit Risk Assessment" RSS

13:56 EDT 21st June 2018 | BioPortfolio

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Showing "hold workshop structured benefit risk assessment" PubMed Articles 1–25 of 26,000+

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis.

Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER)...

Confirmatory versus explorative endpoint analysis: Decision-making on the basis of evidence available from market authorization and early benefit assessment for oncology drugs.

The early benefit assessment of pharmaceuticals in Germany and their preceding market authorization pursue different objectives. This is reflected by the inclusion of varying confirmatory endpoints within the evaluation of oncology drugs in early benefit assessment versus market authorization, with both relying on the same evidence. Data from assessments up to July 2015 are used to estimate the impact of explorative in comparison to confirmatory endpoints on market authorization and early benefit assessment...

Use of risk assessment instruments to predict violence in forensic psychiatric hospitals: a systematic review and meta-analysis.

Violent behaviour by forensic psychiatric inpatients is common. We aimed to systematically review the performance of structured risk assessment tools for violence in these settings.

Current and future cardiovascular disease risk assessment in the European Union: an international comparative study.

Risk assessment is central to primary prevention of cardiovascular disease (CVD), but there remains a need to better understand the use of evidence-based interventions in practice. This study examines: (i) the policies and guidelines for risk assessment in Europe, (ii) the use of risk assessment tools in clinical practice and (iii) the barriers to, and facilitators of, risk assessment.

Low-dose aspirin for primary prevention of cardiovascular events in patients with diabetes: Benefit or risk?

Primary prevention aims to avert the onset of cardiovascular disease (CVD) by targeting its natural causes and risk factors; secondary prevention includes strategies and therapies that address preclinical or clinical evidence of CVD progression. The value of aspirin for primary CVD prevention is controversial because of increased bleeding, which may offset the overall modest benefits in patients with no overt CVD. In contrast, the benefits of aspirin for secondary prevention have been repeatedly and convinc...

Decreasing the risk of SUDEP: Structured communication of risk factors for premature mortality in people with epilepsy.

Good practice guidelines highlight the importance of making people with epilepsy aware of the risk of premature mortality in epilepsy particularly due to Sudden Unexpected Death in Epilepsy (SUDEP). The SUDEP and Seizure Safety Checklist ("Checklist") is a structured risk communication tool used in UK clinics. It is not known if sharing structured information on risk factors allows individuals to reduce SUDEP and premature mortality risks.

Ethical considerations of researchers conducting pediatric clinical drug trials: a qualitative survey in two Belgian university children's hospitals.

There is a general consensus about the underlying theoretical ethical principles that ground the practice of pediatric clinical trials: scientific necessity, good risk/benefit ratio, minimized burden, and parental consent/child assent. However, these principles are so broadly construed that it is not always clear how they should be applied in clinical practice. We conducted a qualitative study at Ghent University Hospital and the hospital of the Dutch-speaking university of Brussels on how researchers weigh...

The role of satellite remote sensing in structured ecosystem risk assessments.

The current set of global conservation targets requires methods for monitoring the changing status of ecosystems. Protocols for ecosystem risk assessment are uniquely suited to this task, providing objective syntheses of a wide range of data to estimate the likelihood of ecosystem collapse. Satellite remote sensing can deliver ecologically relevant, long-term datasets suitable for analysing changes in ecosystem area, structure and function at temporal and spatial scales relevant to risk assessment protocols...

Benefit, risk and cost of new oral anticoagulants and warfarin in atrial fibrillation; A multicriteria decision analysis.

Warfarin and new oral anticoagulants are effective in reducing stroke in atrial fibrillation; however, the benefits and risks rates in clinical trials show heterogeneity for each anticoagulant, and is unknown the cost influence on a model considering most of the treatment consequences. We designed a benefit-risk and cost assessment of oral anticoagulants.

The evaluation of three comorbidity indices in predicting postoperative complications and readmissions in pediatric urology.

The surgical comorbidity assessment is important for patient risk stratification, counseling, and research. In adults, risk assessment indices, such as the Charlson Co-morbidity Score (CCS) or Van Walraven Index (VWI), are well established. In pediatrics, however, risk assessment indices are scarce. Recently, a pediatric-specific risk assessment index, the Rhee index, was developed to discriminate mortality for pediatric general surgery patients. Currently, there is no validated risk assessment tool in pedi...

Development and Internal Validation of the Abdominoplasty Risk Calculator.

Risk calculators are an emerging tool that provide granular, individualized risk estimation. Presently, there is a paucity of risk calculators specific to plastic surgery. Abdominoplasty is a popular plastic surgery procedure associated with moderate risks of complications, such as surgical-site infection and dehiscence, and would benefit from the ability to provide patients with accurate, personalized risk assessment.

Analysis of Late AMNOG Benefit Assessments.

Since 2011, new drugs are assessed at the time of launch in Germany (AMNOG). Based on this early benefit assessment (EBA), drug prices are negotiated. At this time, the evidence base might be weak. A later benefit assessment (LBA) is not done on a regular basis except for selected drugs. Our objective was to analyze the impact of LBAs of drugs for the same indication.

The dilemmas of science for policy: Scientific evidence and the consequences of regulatory options in risk and benefit assessment.

Sex Offender Risk Assessment: Where Are We and Where Are We Going?

Risk assessment is one of the most ubiquitous tasks in the criminal justice system, informing virtually every decision made about offenders. This review, intended for researchers and practitioners, outlines some of the most important recent advances, emerging issues, and recommendations in sex offender risk assessment.

Why Suicide Risk Assessment Still Matters.

Both public awareness of suicide and professional efforts directed at suicide prevention have increased considerably in recent years. Unfortunately, rates of death by suicide have remained relatively stable over the past decade despite these enhanced efforts. Some have argued that "suicide risk assessment doesn't work" and have called into question the utility of devoting clinical time and energy to risk assessment. In this column, the authors first present an overview of the argument against suicide risk a...

Analysis of the Risks and Benefits of New Chemical Entities Approved by the US Food and Drug Administration (FDA) and Subsequently Withdrawn From the US Market.

Benefit-risk evaluations of drugs have been conducted since the introduction of modern regulatory systems more than 50 years ago. Such judgments are typically made on the basis of qualitative or semiquantitative approaches, often without the aid of quantitative assessment methods, the latter having often been applied asymmetrically to place emphasis on benefit more so than harm. In an effort to preliminarily evaluate the utility of lives lost or saved, or quality-adjusted life-years (QALY) lost and gained a...

Ecofriendly nanotechnologies and nanomaterials for environmental applications: Key issue and consensus recommendations for sustainable and ecosafe nanoremediation.

The use of engineered nanomaterials (ENMs) for environmental remediation, known as nanoremediation, represents a challenging and innovative solution, ensuring a quick and efficient removal of pollutants from contaminated sites. Although the growing interest in nanotechnological solutions for pollution remediation, with significant economic investment worldwide, environmental and human risk assessment associated with the use of ENMs is still a matter of debate and nanoremediation is seen yet as an emerging t...

The Art of Cardiovascular Risk Assessment.

The authors would like to submit two corrections on the recently published manuscript, Art of Cardiovascular Risk Assessment. In section 4, the original sentence states: "However, the SCCT does not recommend use of a CAC score in low-risk patients with an ASCVD risk of < 10%." We would like to correct this to "Furthermore, the SCCT recommends consideration of a CAC score in those with a risk score of 5-20% and selectively in those with lower predicted risk who have a family history of premature ASCVD or oth...

Maintenance of Physical Function 1 Year After Exercise Intervention in At-Risk Older Adults: Follow-up From the LIFE Study.

Structured physical activity interventions delay the onset of disability for at-risk older adults. However, it is not known if at-risk older adults continue to participate in physical activity or maintain mobility benefits after cessation of structured intervention.

The Interface of Pancreatic Cancer With Diabetes, Obesity, and Inflammation: Research Gaps and Opportunities: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop.

A workshop on "The Interface of Pancreatic Cancer with Diabetes, Obesity, and Inflammation: Research Gaps and Opportunities" was held by the National Institute of Diabetes and Digestive and Kidney Diseases on October 12, 2017. The purpose of the workshop was to explore the relationship and possible mechanisms of the increased risk of pancreatic ductal adenocarcinoma (PDAC) related to diabetes, the role of altered intracellular energy metabolism in PDAC, the mechanisms and biomarkers of diabetes caused by PD...

Consent and labeling in the use of infectious risk donor kidneys: a response to "Information Overload.

We thank Singh et al for their interest in our work on the survival benefit conferred by increased infectious risk kidneys (IRD) (1). We agree that our findings of substantial benefit and elevated discard rates of IRD kidneys, coupled with existing literature on their low infectious risk, support broader utilization of these so-labeled kidneys. Physicians and patients considering these offers can also turn to our risk calculator ( to quantify the personalized survival benefit o...

Combining ecosystem services assessment with structured decision making to support ecological restoration planning.

Accounting for ecosystem services in environmental decision making is an emerging research topic. Modern frameworks for ecosystem services assessment emphasize evaluating the social benefits of ecosystems, in terms of who benefits and by how much, to aid in comparing multiple courses of action. Structured methods that use decision analytic-approaches are emerging for the practice of ecological restoration. In this article, we combine ecosystem services assessment with structured decision making to estimate ...

Statin Eligibility in Primary Prevention: From a Risk-Based Strategy to a Personalized Approach Based on the Predicted Benefit.

Guidelines have recommended statin initiation based on the absolute cardiovascular risk. We tested the hypothesis that a strategy based on the predicted cardiovascular benefit, compared with the risk-based approach, modifies statin eligibility and the estimated benefit in a population in primary cardiovascular prevention. The study included 16,008 subjects (48 ± 6 years, 73% men) with low-density lipoprotein cholesterol levels of 70 to 

Workshop on acceleration of the validation and regulatory acceptance of alternative methods and implementation of testing strategies.

This report describes the proceedings of the BfR-RIVM workshop on validation of alternative methods which was held 23 and 24 March 2017 in Berlin, Germany. Stakeholders from. governmental agencies, regulatory authorities, universities, industry and the OECD were invited to discuss current problems concerning the regulatory acceptance and implementation of alternative test methods and testing strategies, with the aim to develop feasible solutions. Classical validation of alternative methods usually involves ...

Evaluation of Risk Versus Benefit Information in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements.

The FDA's Presenting Risk Information draft guidance from May 2009 states that the time of risk versus benefit is a factor taken into consideration when evaluating audio and video direct-to-consumer (DTC) broadcasts. The objective of the study is to evaluate the proportion of risk narration on television (TV) advertisements in comparison to the actual proportion of serious adverse effects findings across select therapeutic areas.

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