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miércoles, 13 de marzo de 2013

"The informed consent to patient in Clinical Trials."

The informed consent needed be monitoring to take strongly care about patiente. Follow  that irecommended ensure subjects by University of Minnesota:


    -. Ensure the form contains all necessary criteria as required by FDA regulations, protocol requirements, 

       and IRB policies.
    -. Ensure the form is properly signed and dated by the subject.
    -. Ensure the subject reads and signs the correct version of the form.
    -. Ensure a Legally Authorized Representative or witness signs and dates the form when necessary.
    -. Ensure the investigative site has a well-defined informed consent procedure.
    -. Ensure the consenter is properly trained.
    -. Ensure a consent discussion has taken place in which the subject as time to ask questions.
    -. Ensure the consent process is completed before study procedures are initiated.

I add interesting English-Spanish glossary to build informed consent in spanish, by

Pablo Mugüerza, Lida Barbetti Vros, and Lorenzo Gallego-Borghini.

lunes, 11 de marzo de 2013

"Genomics Oncology and Clinical Trials System"

The specific knowledges and  their sinergies between them, could be good way to investigation. You may find it on this interesting published "Oncology Enters Era of Genomics: Sledge Calls for Overhaul of Clinical Trials System".

To advance in genomics trials are propose "multitargeting", greater collaboration among research entities, an information network for clinical trials, a redesigned informed consent process, and a “fundamentally different regulatory apparatus.”

George W. Sledge, Jr, MD

"Genomics Oncology and Clinical Trials System"

La troncalitat a la Llei 44/2003 d'ordenació de les activitats sanitàries per al desenvolupament de l'anàlisi clínica.

Interessant descoberta en la reforma educativa a làrea de les ciències de la salut, a la passada edició INFARMA 2013, a la conferencia " Relació entre la professió farmacèutica i el laboratori d'anàlisi clínica", a carreg, entre d'altres ponents,  de la Sra. Marta García Collía, cap del servei de Bioquímica Clínica al "Hospital Universitario Ramón y Cajal", vocal d'anàlisi Clínic del COF de Madrid, i Vocal Nacional de Anàlisi Clínic del "Consejo General de Colegios de Farmacéuticos de España".

La troncalitat en les especialitats de bioquímica, genètica clínica i anàlisi clínic serà una realitat en la Llei 44/2003 d'ordenació de les activitats sanitàries per al desenvolupament de l'anàlisi clínica.


Les especialitats del mateix tronc tindran un període de formació comú d'una duració mínima de dos anys, i uns altres dos d'especialització. Amb aquesta fusió es pretén  dotar d'àrees de capacitació específica, millora en l'eficiència i els paràmetres de qualitat, i una major eficàcia en la fase analítica, mitjançant la unificació  de les diferents disciplines, i la compartició de recursos. Sens dubte una millora a l'anàlisi clínica.






jueves, 20 de diciembre de 2012


Sustainability and mobility
Sustainability and mobility always are a complex couple. Optimal use could be to combine different synergies existing between a diverse sort transport. Read about Urban Mobility on MIT News, an interesting project have won the Audi Urban Futures 2012 Award..... I recommend you!



                                                                MIT School of Architecture + Planning

viernes, 7 de diciembre de 2012

Can ethics committees help tackle publication bias?

 

" If studies are done in human subjects but not published, then those studies might as well not have been done at all. Worse still, if the studies that are not published are systematically different from the ones that are (and the evidence is pretty clear that they are, and that positive studies are more likely to be published than negative ones), non-publication of research can seriously bias the literature. This is known as publication bias".

"The problem of publication bias has been on the radar of many people in recent years, although because of the long lag times in researching such things, it’s not clear to what extent recent efforts to fix the problem have been successful. Nonetheless, it’s probably safe to assume that the problem has not been 100% fixed, and that some studies are still done in human subjects and do not get published. To ensure the completeness of the medical literature, it is therefore important to ensure that such efforts continue".

IIt's an interesting blogpost about publishing in Clinical Trial. Read more here
.