terça-feira, fevereiro 28, 2006
Dia Internacional do Ensaio Clínico
20th May 2006
Location: EU Commission, Brussels,
Time: Friday May 19th, 2006 from 10.30 to 13.30
Clinical research requires the active involvement of patients in order to assess the benefits and harms of interventions (drugs, surgery, biotechnology, etc.). The participants in clinical trials may run personal risks for the sake of the common good. The International Clinical Trials’ Day will help to foster awareness of patients and the population in general about the methods and challenges of clinical research. It will also foster discussion and debate among participants in clinical trials, practitioners, researchers, and funders of research (including the drug and device industry).
In recent years, there has been a rapid evolution of legislative and ethical frameworks for clinical research, debates on transparency, and active participation of patients and patients’ associations in the design, organisation, and exploitation of clinical trials. The International Clinical Trials’ Day will become an international focal point for communication events, meetings, and debates on these topics. Because the public health challenges of clinical research are not restricted to a single country, the transnational communication about clinical trials needs initiation and co-ordination by a transnational organisation, having the objective to facilitate better clinical research, relevant to the needs of patients everywhere.
Establishing a Europe-wide and even world-wide communication event under the umbrella of an International Clinical Trials’ Day will allow us all to focus on the central importance of clinical research and clinical trials to the qualities and abilities of our health-care systems. Through various communication channels (meetings and debates with patients, academia, and industry at regional level in various countries, teaching programmes at schools, television and radio programmes, newspapers, and scientific journals), this event will allow to target the patients, patients’ associations, and the general population and will allow in depth discussion with representatives of academic or industry research and with regulators and ethics committees, on the challenges raised by clinical research.
This event was initiated by the Framework Programme 6-funded European Clinical Research Infrastructures Network (ECRIN) in 2005 (http://www.ecrin.org). The May 20th was chosen as the day of celebration with focus on clinical research and clinical trials because it was the day when the Scottish naval surgeon, James Lind, started his famous controlled trial in 1747 (see The James Lind Library at http://www.jameslindlibrary.org/). Other countries have already expressed their interest and commitment to participate in this activity (USA, Canada, Australia). The starting point for this international event will be a workshop followed by a press conference, organised in Brussels under the auspices of the EU Commission in collaboration with the World Health Organisation (WHO) on May 19th to celebrate the International Clinical Trials’ Day on May 20th, 2006. Representatives of European patients’ associations, clinical scientists, scientific agencies, industry sponsors, ethics committees, competent authorities, trials registries, medical journal editors, and the EU Commission will debate with patients’ associations, scientific journals, and news media on the need to improve patients’ and publics’ awareness on the challenges raised by clinical research.