Klaus Romero

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Optimal therapeutic decision-making requires integration of patient-specific and therapy-specific information at the point of care, particularly when treating patients with complex cardiovascular conditions. The formidable task for the prescriber is to synthesize information about all therapeutic options and match the best treatment with the characteristics(More)
Aiming to emulate the successful accelerated development of HIV/AIDS drugs, the Critical Path Institute (C-Path), in collaboration with the Engelberg Center for Health Care Reform at the Brookings Institution, has formed the Coalition Against Major Diseases (CAMD). Members include 6 nonprofit groups representing patients' interests, 15 leading(More)
Our objective was to develop a beta regression (BR) model to describe the longitudinal progression of the 11 item Alzheimer’s disease (AD) assessment scale cognitive subscale (ADAS-cog) in AD patients in both natural history and randomized clinical trial settings, utilizing both individual patient and summary level literature data. Patient data from the(More)
Failures in trials for Alzheimer's disease (AD) may be attributable to inadequate dosing, population selection, drug inefficacy, or insufficient design optimization. The Coalition Against Major Diseases (CAMD) was formed in 2008 to develop drug development tools (DDT) to expedite drug development for AD and Parkinson's disease. CAMD led a process that(More)
Interactions of warfarin with other drugs or substances can pose a serious problem. We assessed three drug information compendia-Clinical Pharmacology, ePocrates, and Micromedex-and the warfarin sodium (Coumadin) product label (August 2007) approved by the US Food and Drug Administration for listings of interactions between warfarin and drugs, biologics,(More)
BACKGROUND Because interactions with warfarin represent a serious risk to patients, drug information sources used by clinicians should contain accurate, timely, and practical drug interaction information. OBJECTIVE The aim of this study was to assess the information regarding warfarin interactions that is included in the official labeling of prescription(More)
INTRODUCTION Data obtained in completed Alzheimer's disease (AD) clinical trials can inform decision making for future trials. Recognizing the importance of sharing these data, the Coalition Against Major Diseases created an Online Data Repository for AD (CODR-AD) with the aim of supporting accelerated drug development. The aim of this study was to build an(More)
Alzheimer’s disease (AD) and Parkinson’s disease (PD) pose significant challenges for successful development of new therapies, with anextremely high drug trial failure rate and yet no approved disease modifying drugs available. Given the magnitude of the challenges, it has become clear that larger collaborations and multi-partner joint efforts, pooling(More)
For decades, medical practice has increasingly relied on prescription medicines to treat, cure, or prevent illness but their net benefit is reduced by prescribing errors that result in adverse drug reactions (ADRs) and tens of thousands of deaths each year. Optimal prescribing requires effective management of massive amounts of data. Clinical decision(More)
BACKGROUND The hollow fiber system model of tuberculosis (HFS-TB), in tandem with Monte Carlo experiments, represents a drug development tool (DDT) with the potential for use to develop tuberculosis treatment regimens. However, the predictive accuracy of the HFS-TB, or any other nonclinical DDT such as an animal model, has yet to be robustly evaluated. (More)