Annals of the New York Academy of Sciences
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Ann. N. Y. Acad. Sci. · Sep 2014
ReviewThe evolution of the regulatory framework for antibacterial agents.
The rising tide of antibacterial resistance and the lack of a diverse, vibrant pipeline of novel antibacterial agents is a global crisis that impairs our ability to treat life-threatening infections. The recent introduction of a tiered approach to the regulatory framework in this area offers one path to resolving some of the challenges. ⋯ There are limitations to these pathways, and they are not easy to implement, but making reliable noninferiority-based approaches available is critical to reinvigorating the global antibiotic pipeline. With the recognition of these ideas by key regulatory authorities in recent guidance, the next challenges in this area will focus on interpretive breakpoints, the extent of data in the prescribing information, ensuring that multiple agents can be progressed, and the challenge of the antibiotic business model.
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Ann. N. Y. Acad. Sci. · Aug 2014
ReviewFine- and coarse-filter conservation strategies in a time of climate change.
As species adapt to a changing climate, so too must humans adapt to a new conservation landscape. Classical frameworks have distinguished between fine- and coarse-filter conservation strategies, focusing on conserving either the species or the landscapes, respectively, that together define extant biodiversity. ⋯ Novel approaches combine coarse- and fine-scale approaches--for example, prioritizing species within pretargeted landscapes--and accommodate the difficult reality of multiple interacting stressors. By taking a diversified approach to conservation actions and decisions, conservationists can hedge against uncertainty, take advantage of new methods and information, and tailor actions to the unique needs and limitations of places, thereby ensuring that the biodiversity show will go on.
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Ann. N. Y. Acad. Sci. · May 2014
ReviewWhen and for how long should glucocorticoids be used in rheumatoid arthritis? International guidelines and recommendations.
Glucocorticoids are widely used in rheumatoid arthritis (RA); however, their effectiveness and safety is still a subject of debate. In particular, when to introduce glucocorticoids, but also when and how to taper them, are important questions for clinicians. ⋯ The recommendations cover the introduction of glucocorticoids (and for whom they are recommended), doses and duration of treatment, and tapering strategies. Items still on the research agenda include more data on safety, particularly for long-term use, and small doses of glucocorticoids.
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Ann. N. Y. Acad. Sci. · Apr 2014
Alzheimer's disease research and development: a call for a new research roadmap.
Epidemiological projections of the prevalence of Alzheimer's disease (AD) and related dementias, the rapidly expanding population over the age of 65, and the enormous societal consequence on health, economics, and community foretell of a looming global public health crisis. Currently available treatments for AD are symptomatic, with modest effect sizes and limited impact on longer term disease outcomes. ⋯ An unprecedented collaborative effort of government, regulators, industry, academia, and the community at-large is needed to address this crisis and to develop an actionable plan for rapid progress toward successfully developing effective treatments. Here, we map out a course of action in four key priority areas, including (1) addressing the fundamental mechanisms of disease, with the goal of developing a core set of research tools, a framework for data sharing, and creation of accessible validated and replicated disease models; (2) developing translational research that emphasizes rapid progress in disease model development and better translation from preclinical to clinical stages, deploying leading technologies to more accurately develop predictive models; (3) preventing AD through the development of robust methods and resources to advance trials and creating fundamental resources such as continuous adaptive trials, registries, data repositories, and instrument development; and (4) innovating public/private partnerships and global collaborations, with mechanisms to incentivize collaborations and investments, develop larger precompetitive spaces, and more rapid data sharing.
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Ann. N. Y. Acad. Sci. · Jan 2014
Randomized Controlled TrialIntegrating nutrition and early child-development interventions among infants and preschoolers in rural India.
This article describes the development, design, and implementation of an integrated randomized double-masked placebo-controlled trial (Project Grow Smart) that examines how home/preschool fortification with multiple micronutrient powder (MNP) combined with an early child-development intervention affects child development, growth, and micronutrient status among infants and preschoolers in rural India. The 1-year trial has an infant phase (enrollment age: 6-12 months) and a preschool phase (enrollment age: 36-48 months). Infants are individually randomized into one of four groups: placebo, placebo plus early learning, MNP alone, and MNP plus early learning (integrated intervention), conducted through home visits. ⋯ The evaluation examines whether the effects of the MNP intervention vary by the quality of the early learning opportunities and communication within the AWCs. Study outcomes include child development, growth, and micronutrient status. Lessons learned during the development, design, and implementation of the integrated trial can be used to guide large-scale policy and programs designed to promote the developmental, educational, and economic potential of children in developing countries.