WHO nimmt die Forderung nach Offenlegung aller Studiendaten auf

(16.10.2014) Auch die WHO spricht sich inzwischen für eine Offenlegung aller Studien aus und fordert dazu auf, Ihren Entwurf einer entsprechenden Politik öffentlich zu kommentieren. Den Anstoß dazu gab die internationale AllTrials-Initiative (www.alltrials.net), die nun Ihre Unterstützer bittet, Stellung zu nehmen:

„This is potentially a really significant step. We and other signatories of AllTrials have a chance to press the WHO to state unambiguously that the results of every trial that has taken place, as well as those from now on, should be reported. Also to remind them that the accepted time to report results or offer a reason for delay is 12 months. If the statement covers past trials and timely reporting, as well as the ethical obligation to report, it will greatly assist AllTrials supporters around the world.”

Auch die Deklaration von Helsinki enthält entsprechende Bestimmungen, wie aus dem WHO-Entwurf hervorgeht: „In the latest version of the Declaration of Helsinki it is stated that every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. Researchers have a duty to make publicly available the results of their research. … Negative and inconclusive as well as positive results must be published or otherwise made publicly available. There is an ethical imperative to report the results of all clinical trials.”

Um den WHO-Entwurf zu kommentieren, klicken Sie diesen Link: www.who.int/ictrp/results/en