Academic Life and Culture

 

Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics

The US Food and Drug Administration (FDA) has developed a framework to use data gathered outside of clinical trials (eg, electronic health record [EHR] and insurance claims data) for evaluations of medical product safety and effectiveness. These …

Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing

In the UK, the Medicines and Healthcare products Regulatory Agency consulted on proposals “to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines”. The …

NIAID Centers of Excellence for Influenza Research and Response (CEIRR) Data Standards

The goal of the NIAID Centers of Excellence for Influenza Research and Response (CEIRR) awards is to provide the federal government, scientists, and public health personnel with information and public health tools and strategies needed to control and …

Participatory Research Approaches in Alzheimer’s Disease and Related Dementias Literature: A Scoping Review

Background and Objectives Given the increase in methodological pluralism in research on brain health, cognitive aging, and neurodegenerative diseases, this scoping review aims to provide a descriptive overview and qualitative content analysis of …

The secret to writing a great NASA proposal

Use a real NASA proposal as a roadmap and follow these tips for clearly presenting your research ideas. I’m a 100% soft money-funded research scientist primarily funded by NASA research grants. I teamed with the Jet Propulsion Laboratory (JPL) to …

Why NASA and federal agencies are declaring this the Year of Open Science

I’m thrilled to be the Transform to Open Science lead for NASA, which has a 60-year legacy of pushing the limits of how science is used to understand the Universe, planetary systems and life on Earth. Much of NASA’s success can be attributed to a …

Publication bias in clinical research

In a retrospective survey, 487 research projects approved by the Central Oxford Research Ethics Committee between 1984 and 1987, were studied for evidence of publication bias. As of May, 1990, 285 of the studies had been analysed by the …

Biomedical publishing: Past historic, present continuous, future conditional

Academic journals have been publishing the results of biomedical research for more than 350 years. Reviewing their history reveals that the ways in which journals vet submissions have changed over time, culminating in the relatively recent appearance …

Artificial intelligence and responsibility gaps: What is the problem?

Recent decades have witnessed tremendous progress in artificial intelligence and in the development of autonomous systems that rely on artificial intelligence. Critics, however, have pointed to the difficulty of allocating responsibility for the …

Eleven Strategies for Making Reproducible Research and Open Science Training the Norm at Research Institutions

Across disciplines, researchers increasingly recognize that open science and reproducible research practices may accelerate scientific progress by allowing others to reuse research outputs and by promoting rigorous research that is more likely to …
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