The need for registration of preclinical studies

Abstract

In contrast to controlled clinical trials, findings of preclinical studies are not available. The road from laboratory discovery to usable therapy is still long and windy. Many preclinical studies have not been replicated by the pharmaceutical sector, the costs of clinical trials are rising, and many trials fail due to insufficient animal model evidence. To improve cross-talk between scientists and to develop rational strategies to move therapies into the clinic, scientists are going to be invited to register their experiments. The proposed registration and availability of preclinical research findings, published in the June 2012 issue of Nature Biotechnology by Kimmelman and Anderson, would facilitate a clinical translation process that would benefit the scientific community. In particular, to support clinical trial development programs, they propose the design and registration of controlled in vivo animal studies testing toxicity, toxicology, and disease response with a similar structure to controlled clinical trials.

Keywords:

• Preclinical research
• Clinical trials
• Translational research
• Registration

Acknowledgments

I would like to thank Margaret Gray for copy editing.

Call for Abstracts for Brief Presentations for 38th EMWA Conference, 13–17 May 2014, Budapest, Hungary

Want to get something off your chest? Have something new to suggest? Present your point of view on a controversial issue? Or just tell us about your experiences as a medical writer?

For next year's Spring Conference in Budapest, EMWA has decided to repeat a successful half-day event first held at the 30th Conference in Lisbon, where we opened the floor to all participants who would like to give a brief presentation on any interesting topic related to medical writing. The format is a 10-minute slide presentation followed by 10 minutes for questions and discussion. The topic should be of interest to others and may cover such areas as hot topics, controversial areas, new guidelines, new technologies or just new information that you feel the medical writing world should know.

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Additional information

Notes on contributors

Sanja Pavlica

Dr Sanja Pavlica received a PhD in biochemistry in 2005 from Leipzig University and performed postdoctoral studies in neurochemistry. From August 2007 to 2012, she was Head of the Neuro/Liver Group at the Department of Cell Techniques and Applied Stem Cell Biology, Biotechnological and Biomedical Center, Leipzig University, where she worked in the field of regenerative medicine and tissue engineering and transitioned from pre-clinical to clinical research. Sanja completed a clinical research associate certificate at Leipzig's well-known Pharma Academy. Since 2012, she has worked in a contract research organisation as a clinical research associate and medical writer.