Lundbeck publishes the results from clinical studies of its products and drug development candidates, irrespective of whether the results are positive or negative, and acknowledges a special obligation to publish data related to patient safety.
Per current Good Publication Practice, Lundbeck will submit for publication the results of Lundbeck-sponsored clinical studies, primarily in peer-reviewed journals, or as abstracts, posters, or other presentations at scientific meetings.
Publication activities will be undertaken responsibly and ethically to ensure that all relevant information is communicated clearly and in a timely manner. Wherever possible, manuscripts will be submitted no later than 18 months after study completion for approved products. The commitment to publish also applies to drug development compounds for which development has been discontinued. In situations when the data are of limited scientific or clinical value, or in the case of multiple journal rejections, posting results on a public clinical trial registry site may be an option for disclosure.
Lundbeck encourages publication of the results from drug discovery. The timing of nonclinical publications will take into consideration intellectual property rights as well as legislation and national practices in patent law.
When entering into research and development collaborations, it is Lundbeck’s commitment to maintain ethical and transparent publication practices, which is in accordance with Good Publication Practice (www.ismpp.org/gpp3).