Dec 12, 2014

United for the negative results!

Considering that preclinical research provides the foundation on which many clinical trials are conceived, publication bias becomes a huge problem for the advancement of clinical research, leading to the revision of policies and guidelines on many occasions.

Recently a study conducted by Foster and Putos has been published on how the under-reporting of negative results in preclinical research distorts scientific knowledge and subsequently misguides clinical research.

Although publication bias is not considered scientific misconduct, it may be an even greater threat to science because it is more difficult to detect.

Preclinical research has made a special effort to improve the transparency of published studies, as the knowledge acquired in these disciplines are the basis on which clinical research priorities are set and evidence-based decisions are made. The non-publication of negative results makes up biomedical studies and decreases the validity of publications. That could be a factor responsible for the historically low rate of successful clinical translation from preclinical findings. An example of this is the nitrone-based drug NXY-059 to phase III clinical trials for the treatment of acute stroke, which benefits identified in preclinical studies failed in the clinical intervention.(1)

Non-publication of negative results in preclinical studies, besides involving a huge waste of money in clinical studies based on incomplete studies that do not lead to satisfactory results, also could involve harmful exposure of people who participate in these studies and therefore an increasing distrust in these studies. Not to mention animal studies, where it was recently estimated that 50% of research is never published and that this number may be far greater in for-profit organizations.

Foster and Putos reported some recommendations for achieving more transparent, efficient, and accurate reporting of preclinical research with a focus on strategies for increasing the publication of negative results. According to them, “educating all personnel involved in the publication process on the importance of communicating negative results will be instrumental for the publication of such findings.”

They propose initiatives like the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines, CAMARADES (Collaborative Ap¬proach to Meta-Analysis and Review of Animal Data from Experi¬mental Studies), or the GSPC (Gold Standard Publication Checklist) to increase transparency of all preclinical studies submitted for peer-review.

In the commentary, they encourage both academic and non-academic institutions to organize conferences, seminars, and courses that teach researchers how to fully and accurately report their findings as another initiative to sensitize researchers and students, the heart of primary data generation, about publishing negative results.

Initiatives such as the first course in Journalology taught by the University of Ottawa, or the appearance of journals created for the sole purpose of publishing negative results like The Journal of Negative Results, The Journal of Negative Results in Biomedicine, and The All Results Journals go in the way of scientific progress.

(1) Bath PM, Gray LJ, Bath AJ, Buchan A, Miyata T, Green AR, et al. Effects of NXY-059 in experimental stroke: an individual animal meta-analysis. Br J Pharmacol 2009; 157(7):1157-1171.

Original source

Written by Dra. Belén Suárez Jiménez for The All Results Journals 


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