Sustained unresponsiveness to peanut in subjects who have completed peanut oral immunotherapy.

Background: Although peanut oral immunotherapy (OIT) has been conclusively shown to cause desensitization, it is currently unknown whether clinical protection persists after stopping therapy.

Objective: Our primary objective was to determine whether peanut OIT can induce sustained unresponsiveness after withdrawal of OIT.

Methods: We conducted a pilot clinical trial of peanut OIT at 2 US centers.

Impact of extracardiac vascular disease on vein graft failure and outcomes after coronary artery bypass surgery.

Background: While extracardiac vascular disease (ECVD), defined as a history of peripheral vascular disease (PVD) or cerebrovascular disease (CBVD), is common in patients undergoing coronary artery bypass graft (CABG) surgery, there are limited data available on the association between ECVD, vein graft failure (VGF), and clinical outcomes.

Methods: Using data from the Project of Ex-vivo Vein Graft Engineering via Transfection IV (PREVENTIV) trial (n = 3,014), 1-year angiographic follow-up and 5-year clinical outcomes (death, myocardial infarction, and revascularization) were determined in patients with and without ECVD. Logistic regression was used to assess risk of VGF.

Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation).

Objectives: This study sought to report additional safety results from the ROCKET AF (Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation).

Background: The ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin.

Methods: The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model.

Panel: Alternative Careers for Biomedical Informatics PhDs.

The number of doctoral training programs in informatics increases every year, however not every doctoral candidate wishes to pursue a traditional career in academia. In addition, the knowledge and skills acquired through scientific training at the doctoral level can be valuable, even critical, for a number of career paths outside of academic research and teaching. This panel will present a diverse set of alternative career paths for which graduates of Informatics programs would be well suited, including patent law, research in industry, academic administration, and scientific journalism.

A sea of standards for omics data: sink or swim?

In the era of Big Data, omic-scale technologies, and increasing calls for data sharing, it is generally agreed that the use of community-developed, open data standards is critical. Far less agreed upon is exactly which data standards should be used, the criteria by which one should choose a standard, or even what constitutes a data standard. It is impossible simply to choose a domain and have it naturally follow which data standards should be used in all cases.

Participants' perspectives on safety monitoring in clinical trials.

Background: Minimizing the risk to study participants is an essential requirement of ethical research. Respecting the rights of subjects is also paramount, which includes respecting their autonomy by making available important information about the evolving safety profile of an investigational product as the trial progresses. Little is known about what trial participants understand and expect regarding monitoring and communication of serious adverse events during the conduct of a trial in which they have agreed to participate.

Cycle Time Metrics for Multisite Clinical Trials in the United States.

Conducting randomized controlled trials entails a prolonged, costly study start-up (SSU) process that may create significant delays. Optimizing the operational aspects of multisite trials requires identifying benchmarks in the SSU process and the potential delays associated with them. We engaged in a collaborative effort to identify and describe key SSU intervals that correspond with necessary procedures and processes for activating multisite clinical trials in the US.

Proposed 'grant-and-access' program with price caps could stimulate development of drugs for very rare diseases.

The 1983 Orphan Drug Act created incentives for the development of orphan drugs. Despite its successes, including a substantial increase in new drugs, approved orphan drugs still treat fewer than 5 percent of registered rare diseases. In addition, concerns have arisen about the high prices of many of these therapies, which can cost hundreds of thousands of dollars per patient each year.

Evaluating the impact of public health notification: Duke clopidogrel experience.

Background: Provider and public health interventions in the late 2006 sought to change the duration of clopidogrel use after drug-eluting stent (DES) implantation. We evaluated whether public health interventions were associated with changes in patient-reported clopidogrel use among DES patients.

Methods And Results: We used interrupted time analyses to evaluate trends in duration of patient-reported clopidogrel use before, during, and after public and provider interventions.

Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010.

Context: Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered with ClinicalTrials.gov enable a comprehensive evaluation of the national trials portfolio.

An Altered Treatment Plan Based on Direct to Consumer (DTC) Genetic Testing: Personalized Medicine from the Patient/Pin-cushion Perspective.

Direct to consumer (DTC) genomic services facilitate the personalized and participatory aspects of "P4" medicine, but raise questions regarding use of genomic data in providing predictive and preventive healthcare. We illustrate the issues involved by describing a pregnancy management case in which a treatment plan was modified based on a DTC result. A woman whose personal and family history were otherwise unremarkable for thromboembolism learned through DTC testing about the presence of a prothrombin (factor 2) gene mutation (rs1799963).

Design and implementation of an institutional case report form library.

Background: Case report forms (CRFs) are used to collect data in clinical research. Case report form development represents a significant part of the clinical trial process and can affect study success. Libraries of CRFs can preserve the organizational knowledge and expertise invested in CRF development and expedite the sharing of such knowledge.

The Biomedical Resource Ontology (BRO) to enable resource discovery in clinical and translational research.

The biomedical research community relies on a diverse set of resources, both within their own institutions and at other research centers. In addition, an increasing number of shared electronic resources have been developed. Without effective means to locate and query these resources, it is challenging, if not impossible, for investigators to be aware of the myriad resources available, or to effectively perform resource discovery when the need arises.

Connecting information to improve health.

Effective health information systems require timely access to all health data from all sources, including sites of direct care. In most parts of the world today, these data most likely come from many different and unconnected systems-but must be organized into a composite whole. We use the word interoperability to capture what is required to accomplish this goal.

Linking scientific discovery and better health for the nation: the first three years of the NIH's Clinical and Translational Science Awards.

A comprehensive system for translating basic biomedical research into useful and effectively implemented clinical diagnostic, preventive, and therapeutic practices is essential to the nation's health. The state of clinical and translational research (CTR) in the United States, however, has been characterized as fragmented, slow, expensive, and poorly coordinated. As part of its Roadmap Initiative, the National Institutes of Health instituted the Clinical and Translational Science Awards (CTSA), a sweeping and ambitious program designed to transform the conduct of biomedical research in the United States by speeding the translation of scientific discoveries into useful therapies and then developing methods to ensure that those therapies reach the patients who need them the most.