no post autorización
English translation: (observational epidemiological study) not meeting the characteristics of a post-authorisation study
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| 09:06 Jun 30, 2017 |
| Spanish to English translations [PRO] Medical - Medical: Pharmaceuticals / Clinical trials | |||||||
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|  Selected response from: Charles Davis Spain Local time: 11:03 | ||||||
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| 4 +1 | (observational epidemiological study) not meeting the characteristics of a post-authorisation study |
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| The study in question--no drugs are administered |
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| Discussion entries: 4 | |
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Answers
1 hr confidence: 
peer agreement (net): +1
peer agreement (net): +1(observational epidemiological study) not meeting the characteristics of a post-authorisation study Explanation: Sorry this is such a mouthful, but I don't think we have an expression for this. It's not a typo; it's a well established term. Here's one among many explanations available online: "No-EPA – Estudio observacional no post-autorización También conocidos como estudios epidemiológicos, en ellos el medicamento no es factor de exposición fundamental investigado. Son de carácter descriptivo, y miden a la vez la prevalencia de la exposición y del efecto en una muestra poblacional en un periodo concreto en el tiempo, permitiendo estimar la magnitud y distribución de una enfermedad o condición en un momento dado." http://leonresearch.com/blog/tipos-de-estudios-observacional... PAS (post-authorisation studies), subdivided into PASS (safety) and PAES (efficacy), is of course standard, but we just don't talk about non-PAS, as far as I can tell. And we can't just call these epidemiological studies. They are defined negatively; they are observational epidemiological studies that are not EPA (PAS). I've taken my answer from this site, which as far as I can see is very well written and authoritative: "B.2) STUDIES PREVIOUSLY APPROVED BY OTHER ACCREDITED ETHICS COMMITTEES Favorable rulings handed down by any accredited ethics committee in our country regarding a post-authorization study or an epidemiological study not meeting the characteristics of a post authorization study shall be recognized by health authorities or publicly funded bodies, hospital management, and the hospital's ethics committee; no additional rulings will be required with regard to the ethical aspects of studies previously evaluated by other ethics committees." It also offers clear explanations of the various types of EPA (PAS) in Spain. http://www.fjd.es/iis_fjd/en/clinical-trials-committee/docum... |
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Reference comments
49 mins |
| Reference: see Reference information: http://www.elsevier.es/es-revista-medicina-clinica-2-articul... Otro tipo de estudios son los estudios observacionales no EPA, definidos como aquéllos en los que el factor de exposición fundamental investigado no es un medicamento. estudios postautorización (EPA) -------------------------------------------------- Note added at 57 mins (2017-06-30 10:04:05 GMT) -------------------------------------------------- https://inforeuma.com/wp-content/uploads/2015/09/Faq3.pdf En relación a su consulta sobre los requisitos que debe cumplir el Consentimiento Informado del estudio “Proyecto CarMa”, así como qué CEIC es el competente para evaluarle y emitir el dictamen pertinente, le informo de lo siguiente: Tal y como me indica a través de correo electrónico, remitido el día 5 de mayo de 2010, se trata de un estudio observacional no considerado posautorización, denominado No-EPA. Los estudios observacionales No-EPA son aquellos en los que el factor de exposición fundamental investigado no son medicamentos, aunque curiosamente vienen regulados en la Orden SAS/3470/2009, de 16 de diciembre, por la que se publican las directrices sobre estudios posautorización de tipo observacional para medicamentos de uso humano. |
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1 hr |
| Reference: The study in question--no drugs are administered Reference information: http://www.hra.nhs.uk/news/research-summaries/alx-hpp-501-v1... Research summary We are conducting this study to learn about patients who have Hypophosphatasia (HPP). HPP is an ultra-rare bone disorder caused by gene mutations or changes. These gene mutations result in low or absent levels of an enzyme needed to harden bones. There is no approved treatment for this condition. Due to the rare nature of this disease, and considering the lack of information regarding diagnosis and health care management in a “real world” setting, this study will document the demography, clinical course, and impact of disease on patients of all ages who have HPP. There is no study drug administered in this study, patients who consent to participate will be asked to complete questionnaires at various timepoints, in line with routine clinic visits. We will be collecting data on the routine clinical care of patients of all ages, regardless of the age of onset of HPP, by reviewing patient medical records. There are no protocol specific clinical procedures to be undertaken. We plan to enroll at least 500 patients to better understand the disease. The expected duration of the study is at least 5 years. |
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