New regulations on compensation for injury and death in drug trials.

In 2005, the government amended Schedule Y of the Drugs and Cosmetics Act, 1940, and Rules, 1945, to liberalise the conduct of global drug trials in India. Proponents of this policy had asserted that we needed less, and not more, regulation, in order to expand the business of drug trials. Many from the medical profession, the bioethics community and civil society groups have been critical of this policy.

Análisis del reporte de los eventos adversos en ensayos clínicos cubanos / Analysis of the adverse event report in Cuban clinical assays

La seguridad de un medicamento constituye un asunto de vital importancia, por lo que el reporte de eventos adversos en los ensayos clínicos se considera un eslabón primordial. Se evaluó la calidad de estos reportes en 34 informes finales de estudios coordinados por el Centro Nacional Coordinador de Ensayos Clínicos entre 1993-2002 y en 43 publicaciones de ensayos clínicos realizados en Cuba. Se recogieron en un cuestionario características del estudio y del reporte de eventos adversos, los que se clasificaron en: adecuado, parcialmente adecuado o inadecuado. Se encontró que existen dificultades en el reporte aunque la calidad fue mayor en los informes finales que en las publicaciones. Los mayores problemas fueron: la omisión de datos de intensidad y/o eventos adversos graves y la poca realización de análisis de causalidad. Este trabajo permitió identificar las principales problemáticas que afectan el reporte de seguridad, por lo que se recomienda la realización de entrenamientos metodológicos sobre la temática así como la revisión de las normas y procedimientos establecidos a tal efecto.

Drug safety is very important, so the report of adverse events in the clinical assays is considered an essential link. The quality of these reports was evaluated in 34 final reports of studies coordinated by the National Coordinating Centre of Clinical Assays between 1993 and 2002, and in 43 publications of clinical assays carried out in Cuba. In a questionnaire, there were collected characteristics of the study and of the adverse event report that were classified into adequate, partially adequate or inadequate. Some difficulties were found in the report, although the quality was better in the final reports that in the publications. The greatest problems were the omission of intensity data and/or severe adverse events and the little analysis of causality. This paper allowed to identify the main problems affecting the safety report. That's why, it was recommended to conduct methodological trainings on the topic, as well as to review the norms and procedures established to this end.

Informed consent in an antiretroviral trial in Nigeria.

We examined the process of informed consent in an antiretroviral trial in Nigeria. A semi-structured questionnaire was administered to 88 out of 180 people enrolled in the trial. This covered all aspects of the information disclosed in the leaflet of the antiretroviral trial. We found that 75 (85 per cent) of the respondents knew that the purpose of the research was to test a new drug and 13 (14 per cent) believed that they were receiving free treatment for HIV. Participants understood certain aspects of the research, especially the benefits and duration. Their understanding of the trial's risks and their right to refuse to participate and to withdraw was low. Their level of understanding was significantly related to age but not to gender, marriage, education, religion, employment and occupation. Signed informed consent is not a guarantee that participants have understood the information given to them and therefore made a voluntary decision to participate. Researchers should make sure that the process of obtaining informed consent achieves the desired outcome. This is especially important in the developing world where access to health care is limited, potential participants are poor and literacy levels are low.