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Monitoring Clinical Research

Estudio muestra que los microbicidas vaginales pueden beneficiar al hombre más que a la mujer

Vaginal microbicides may benefit men more than women, study shows
Researchers also say clinical-trial design may mask risk of drug resistance

By Enrique Rivero

Vaginal microbicides currently in clinical trials may be the only weapon that will protect women against infection from HIV. Yet, under likely circumstances, these microbicides may be of more benefit to men than women, according to a new UCLA AIDS Institute study.

The study, which used novel mathematical models to simulate clinical trials and population-level transmission of HIV, appears July 7 in the online issue of Proceedings of the National Academy of Sciences.
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Estudio clínico para medir el impacto de los alimentos en los efectos de droga anti-cáncer

Clinical trial measures impact of food on anti-cancer drug effects
Provocative trial could alter how new cancer drugs are tested

An unusual clinical trial based at the University of Chicago Medicine is seeking to determine whether a drug approved for

Abiraterone acetate

patients with advanced prostate cancer might be safer and just as effective if taken at a much lower dose with food instead of at the full dose on an empty stomach.

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Encuesta revela las razones por las que los médicos evaden reportar errores en línea

Survey Reveals Reasons Doctors Avoid Online Error-Reporting Tools

"Too busy," and "too complicated." These are the typical excuses one might expect when medical professionals are asked why they fail to use online error-reporting systems designed to improve patient safety and the quality of care. But Johns Hopkins investigators found instead that the most common reason among radiation oncologists was fear of getting into trouble and embarrassment.

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Estudios clínicos citados por ignorar estudios relevantes previos

Clinical Trials Cited for Ignoring Previous Relevant Research

Johns Hopkins researchers say failure to consider existing evidence is both unscientific and unethical

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El NCI lanza primer estudio para determinar si los biomarcadores ayudan a guiar en el tratamiento del cáncer de pulmón

NCI Launches First-Ever Study to Determine if Biomarkers Can Help Guide Treatment for Lung Cancer.

Today a large, national clinical trial for non-small cell lung cancer was launched to validate whether a biomarker can predict clinical benefit in the treatment of this disease. Biomarkers, which are molecules found in the body that can signal an abnormal process or disease, would identify a target, known as epidermal growth factor receptor (EGFR). This receptor can be increased in some lung cancers due to the presence of extra copies of its coding gene. These extra copies can result in activation of tumor growth, so drugs that block this activation could have a significant impact on lung cancer treatment. This study, sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, is called MARVEL (Marker Validation for Erlotinib in Lung Cancer) and will attempt to definitively establish the future value of selecting patients for treatment based on the presence or absence of EGFR activation.

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¿Permitiría usted que su hijo o hija participe en una investigación médica?

Would you allow your child to participate in medical research?

To view the article in English go here

La Encuesta Nacional del Hospital C.S. Mott de Niños sobre Salud Infantil encuentra que muchos padres y madres están dispuestos a permitir que sus hijos participen en una investigación médica si el riesgo de daños es mínimo.
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Desarrollo y validación de métodos analíticos para el registro de medicamentos

Desarrollo y validación de métodos analíticos para el registro de medicamentos

Olguín-Pérez, L., Paniagua-Solís, J.

Los estudios clínicos (EC) constituyen una parte medular para el registro de un fármaco ante las autoridades sanitarias de la mayoría de los países. Los EC están constituidos por fases clínicas en humanos con objetivos y tamaño de población específicos para cada una, en algunos casos se pueden requerir protocolos preclínicos en animales de laboratorio; en ambos casos las muestras se analizan con métodos in vivo e in vitro. Uno de los métodos eficientes y consistentemente utilizados para la cuantificación de proteínas es el ELISA (del inglés Enzyme-Linked ImmunoSorbent Assays), por su alta sensibilidad y reproducibilidad.
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La mayoría de voluntarios en estudios clínicos son indiferentes -pero no ciegos a- conflictos financieros de los investigadores

CLINICAL TRIAL VOLUNTEERS MOSTLY INDIFFERENT - BUT NOT BLIND TO - RESEARCHERS’ FINANCIAL CONFLICTS

Unless a researcher has stock ownership in a company whose drug is being tested, telling potential research volunteers about an investigator’s financial interests is unlikely to affect their willingness to volunteer, a new study shows.
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Los tratamientos para el cáncer en fase 3 de investigación clínica son exitosos hasta en un 50% del tiempo

CANCER TREATMENTS IN PHASE 3 TRIALS SUCCESSFUL UP TO HALF OF THE TIME

CHICAGO—About one-fourth to one-half of new cancer treatments that reach assessment in phase 3 randomized clinical trials are eventually proven successful, according to a report in the March 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
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Los hospitales que participan en estudios clínicos pueden proporcionar un mejor cuidado al paciente

HOSPITALS THAT PARTICIPATE IN CLINICAL TRIALS MAY PROVIDE BETTER PATIENT CARE

CHICAGO—Hospitals that participate in clinical trials appear to provide better care for patients with heart attacks or other acute heart events and have lower death rates than hospitals that do not participate in clinical trials, according to a report in the March 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
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