The ECAB is born

In late 1997, the EATG came up with a solution: we set new rules on how community advice was to be sought and created a new vehicle to channel that advice: the European Community Advisory Board (ECAB). The ECAB now meets on regular, pre-set dates, where we can invite companies and researchers to meet with us. We use a hotel and meeting room of our choice and they come as our guests and the meetings happen on our terms. We use those opportunities to share information amongst ourselves and conduct trainings to increase our knowledge on topics like: e.g. research methodology, statistics, pharmacology, immunology, virology, resistance, regulatory processes, vaccines, diagnostics and more.

In the end though, ECAB’s central task is to examine trial protocols and give input to the trial design, with special attention to inclusion and exclusion criteria, and to ensure that patient information leaflets are comprehensible to prospective trial participants and thus ensure true informed consent. We serve as watchdogs who pressure companies and doctors to design trials that reflect the real world and, above all, safeguard the safety of the participants.

Companies prefer to exclude patients with liver abnormalities (e.g. people co infected with Hepatitis C) so that their drugs perform as well as possible. They like to exclude people who have a history of ”abusing drugs“ (a typical term), because companies consider them to be unreliable. Because of the political climate created by the so-called war on drugs in the United States, where the majority of trials are designed, the companies have no interest in studying interactions between their medications and illicit drugs. Even getting companies to study methadone interactions took some convincing until regulatory agencies began to require it. Since its founding, ECAB has been battling away against all of these forms of discrimination that are based on prejudice and politics, and not science.

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