Publication: Métodos cuantitativos aplicados a la investigación farmacoepidemiológica
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2017-09-07
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Universidad Complutense de Madrid
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Abstract
La farmacoepidemiología se podría definir como una ciencia que aplica el conocimiento, métodos y razonamiento epidemiológico al estudio de los usos, efectos beneficiosos y riesgos de los medicamentos en grandes poblaciones. En general, los estudios farmacoepidemiológicos suelen adoptar la forma de estudios observacionales (estudios en los que no existe asignación del tratamiento por parte del investigador), aunque no todas las preguntas en farmacoepidemiología pueden resolverse con un único diseño de estudio, de modo que, en función de la pregunta de investigación, se pueden utilizar una gran variedad de diseños de investigación. Cuando un medicamento llega al mercado, su eficacia a corto y medio plazo se ha demostrado en unos miles de pacientes, habitualmente en ensayos clínicos frente a placebo en poblaciones seleccionadas, siendo la información sobre seguridad en esos momentos limitada, ya que la mayor parte de los estudios previos a la autorización son incapaces de identificar los efectos adversos poco frecuentes. Además, en la práctica clínica habitual, los medicamentos se suelen utilizar durante periodos más largos y con pautas de administración o indicaciones más lábiles que las autorizadas y su uso se extiende a grupos vulnerables (p.ej., pacientes ancianos, con múltiples enfermedades y polimedicados)...
Pharmacoepidemiology could be defined as a science that applies the knowledge, methods and epidemiological reasoning to the study of the (beneficial and adverse) effects and uses of drugs in large populations. In general, pharmacoepidemiological studies usually take the form of observational studies (studies in which there is no treatment allocation by the investigator). However not all questions in pharmacoepidemiology can be answered through the same study design, so that, depending on the research question, a wide variety of epidemiological designs can be used. When a drug comes into the market its effectiveness in the short and medium term has been tested in a few thousand patients, usually in clinical trials performed versus placebo which include selected populations, being the safety information limited at this moment, since most of the pre-authorization studies are unable to identify rare adverse effects. In addition, in clinical practice, drugs are often used for longer periods and in therapeutic indications regimens more labile than the ones authorized and its use extends to vulnerable groups (e.g., the elderly, patients with multiple diseases, polypharmacy). The need for additional information beyond randomized clinical trials performed during the phase prior to the authorization of the medicinal justifies the continued research of the drug once is marketed by using different quantitative methods...
Pharmacoepidemiology could be defined as a science that applies the knowledge, methods and epidemiological reasoning to the study of the (beneficial and adverse) effects and uses of drugs in large populations. In general, pharmacoepidemiological studies usually take the form of observational studies (studies in which there is no treatment allocation by the investigator). However not all questions in pharmacoepidemiology can be answered through the same study design, so that, depending on the research question, a wide variety of epidemiological designs can be used. When a drug comes into the market its effectiveness in the short and medium term has been tested in a few thousand patients, usually in clinical trials performed versus placebo which include selected populations, being the safety information limited at this moment, since most of the pre-authorization studies are unable to identify rare adverse effects. In addition, in clinical practice, drugs are often used for longer periods and in therapeutic indications regimens more labile than the ones authorized and its use extends to vulnerable groups (e.g., the elderly, patients with multiple diseases, polypharmacy). The need for additional information beyond randomized clinical trials performed during the phase prior to the authorization of the medicinal justifies the continued research of the drug once is marketed by using different quantitative methods...
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Tesis inédita de la Universidad Complutense de Madrid, Facultad de Medicina, Departamento de Farmacología, leída el 08-11-2016