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Increasing quality and transparency of preclinical data: an opportunity for publication professionals?

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Preclinical studies are an essential component of clinical development plans. However, there are no mandated regulatory standards or requirements for the reporting of preclinical animal research, raising concerns about quality and transparency. Following recent calls to action, including an open letter to the Editor of USA Today and two Editorials in the BMJ, John P. Gonzalez from Solanum Medical Communications (Macclesfield, UK) provides his thoughts on the opportunities this could provide for publication professionals in a recent article for the MAP newsletter from the International Society of Medical Publications Professionals (ISMPP).

Despite the importance of preclinical animal research to inform which compounds should be investigated in human clinical trials, Dr Gonzalez notes that a large proportion of preclinical data are never published. Additionally, information may be incomplete or absent in published preclinical studies, causing problems for researchers who wish to replicate study designs/results. A survey of preclinical publications found that some omitted the hypothesis/objective, and the methods and results were appropriately described in only 70% of those studies that used statistical methods. There is a clear need to improve the publication standards of preclinical research, although some progress is being made. For example, an international register has been developed to provide a comprehensive listing of preclinical study protocols. Dr Gonzalez also highlights the guidelines available on the EQUATOR Network, which may help to improve the reporting of preclinical data.

Dr Gonzalez believes that the recent calls to increase transparency and publication standards of preclinical research could provide publication professionals with an opportunity. Time and resource appear to be a key barrier to achieving publication of preclinical data, and this could be alleviated by offering medical writing support and providing formal publication planning and delivery to researchers. Additionally, he suggests that researchers could be educated on relevant aspects of GPP3 and ICMJE recommendations to improve publication practices. However, as Dr Gonzalez remarks, a move to the publication of all preclinical data is only likely to happen following regulatory changes.

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Summary by Emma Evans PhD, CMPP from Aspire Scientific

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With thanks to our sponsors, Aspire Scientific Ltd and NetworkPharma Ltd


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