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Meaningful benefits: a framework to assess disease-modifying therapies in preclinical and early Alzheimer’s disease
BackgroundThe need for preventive therapies that interrupt the progression of Alzheimer’s disease (AD) before the onset of symptoms or when symptoms...
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The search for clarity regarding “clinically meaningful outcomes” in Alzheimer disease clinical trials: CLARITY-AD and Beyond
CLARITY-AD is an 18-month, double-blinded, placebo-controlled, phase 3 trial which examined the safety and efficacy of the anti-amyloid agent,...
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Combined Cognitive and Psychological Interventions Improve Meaningful Outcomes after Acquired Brain Injury: A Systematic Review and Meta-Analysis
Interventions addressing cognitive and emotional difficulties after acquired brain injury (ABI) often focus on specific impairments in cognition or...
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A Sponsor’s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan
BackgroundFollowing marketing authorization in Japan, for almost all new drugs or new indications, postmarketing studies (PMS) are a regulatory...
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The survival benefit of adjuvant trastuzumab with or without chemotherapy in the management of small (T1mic, T1a, T1b, T1c), node negative HER2+ breast cancer
There is limited data regarding the added benefit of adjuvant systemic therapy in the management of small, node-negative, HER2+ breast cancer. In a...
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A Retrospective Review of Center for Biologics Evaluation and Research Advisory Committee Meetings in the Context of the FDA’s Benefit-Risk Framework
The US FDA Center for Biologics Evaluation and Research (CBER) is responsible for the regulation of biologically derived products. FDA has...
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Isatuximab, lenalidomide, dexamethasone and bortezomib in transplant-ineligible multiple myeloma: the randomized phase 3 BENEFIT trial
CD38-targeting immunotherapy is approved in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma (NDMM)...
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Global Landscape of Benefit–Risk Considerations for Medicinal Products: Current State and Future Directions
In the last decade there has been a significant increase in the literature discussing the use of benefit–risk methods in medical product (including...
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Risk Assessment and Risk-Benefit Assessment
The framework of risk analysis has become the principal procedure for dealing with food safety issues. Risk analysis consists of three components:...
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Using the benefit-harm trade-off method to determine the smallest worthwhile effect of intensive motor training on strength for people with spinal cord injury
Study designInterviews using the benefit-harm trade-off method and an online survey.
ObjectivesTo determine the smallest worthwhile effect (SWE) of...
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Optimal balance of benefit versus risk for tafenoquine in the treatment of Plasmodium vivax malaria
A single 300 mg dose of tafenoquine (an 8-aminoquinoline), in combination with a standard 3-day course of chloroquine, is approved in several...
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Benefit finding in men affected by prostate cancer prior to and following radical prostatectomy – a cross-sectional study with a stratified sample
BackgroundBenefit finding (BF) - the occurrence of positive life-changes in the aftermath of traumatic live events - has been repeatedly reported in...
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Can humans perceive the metabolic benefit provided by augmentative exoskeletons?
BackgroundThe purpose of augmentative exoskeletons is to help people exceed the limitations of their human bodies, but this cannot be realized unless...
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Predicting neoadjuvant chemotherapy benefit using deep learning from stromal histology in breast cancer
Neoadjuvant chemotherapy (NAC) is a standard treatment option for locally advanced breast cancer. However, not all patients benefit from NAC; some...
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Stereotactic body radiotherapy extends the clinical benefit of PD-1 inhibitors in refractory recurrent/metastatic nasopharyngeal carcinoma
PurposeEmerging evidence shows that immune checkpoint inhibitors lead to durable responses in a variety of cancers, including nasopharyngeal...
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Together-Equitable-Accessible-Meaningful (TEAM) Training to Improve Cancer Care for Sexual and Gender Minorities (SGM): Outcomes from a Pilot Study
To alleviate health disparities experienced by sexual and gender minority (SGM) patients, cancer care professionals need further education on the...
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Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration
BackgroundWe describe the clinical benefit of immune checkpoint inhibitors using the European Society for Medical Oncology Magnitude of Clinical...
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Breast cancer hypoxia in relation to prognosis and benefit from radiotherapy after breast-conserving surgery in a large, randomised trial with long-term follow-up
BackgroundBreast-conserving surgery followed by radiotherapy is part of standard treatment for early-stage breast cancer. Hypoxia is common in cancer...
