Volume 22, Issue 2 - Medical Writing Around the World
The need for registration of preclinical studies
Author: Sanja Pavlica
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.
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References
- Laine C, Horton R, De Angelis C, Drazen JM, Frizelle FA, Godlee F, et al. Clinical trial registration: looking back and moving ahead. Ann Intern Med 2007;147(4):275–7.
- Kimmelman J, Anderson JA. Should preclinical studies be registered? Nat Biotechnol 2012;30(6):488–9.
- Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2004;3(8):711–5.
- Sena E, van der Worp HB, Bath PM, Howells DW, Macleod M. Publication bias in reports of animal stroke studies leads to major overstatement of efficacy. PLoS Biol 2010;8:e1000344.
- Bath PM, Gray LJ, Bath AJ, Buchan A, Miyata T, Green AR. Effects of NXY-059 in experimental stroke: an individual animal meta-analysis. Br J Pharmacol 2009;157(7):1157–71.
- Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ 2012;344:d7292.
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