Lapchak PA. Scientific Rigor Recommendations for Optimizing the Clinical Applicability of Translational Research. J Neurol Neurophysiol. 2012;3. pii: e111.
The approval of new therapies to treat neurodegenerative disease conditions by the Food and Drug administration (FDA) has been hindered by many failed clinical trials, which were based upon “significant” efficacy in preclinical or translational studies. Additional problems during drug development related to significant adverse events and unforeseen toxicity have also hampered drug development. Recent reviews of preclinical data suggests that many studies have over-estimated efficacy due to poor or inadequate study design, exclusion of important data (negative or neutral) and lack of study randomization and blinding. This makes recommendations (this is open access so have a read) to improve the quality of science being conducted in laboratories worldwide, with the goal of documenting in the peer-reviewed literature the scientific basis for the continued development of specific strategies to treat neurodegenerative diseases. The minimum recommendations for effective translational research include the need for model justification, study group randomization and blinding, power analysis calculations, appropriate statistical analysis of all data sets, and a conflict of interest statement by investigators. It will also be beneficial to demonstrate reproducible efficacy in multiple species and in studies done by independent laboratories.
So yet another (Neurological) editor calling for more transparent reporting of animal studies…..or is it a call for us to do a student project in a years time to see if the editor is just full of hot air, as most are, or whether they actually enforce these views.
We have seen that without editorial action nothing happens.
The momentum is gathering pace and so any researchers reading this post, Take note! and begin to introduce these experimental design aspects into your reporting, as it is coming whether you like it or not.
One aspect suggested here is to repeat results, in different species and possibly labs. We have seen that some data cannot be even repeated in the same type of experiment and this can be dealt with having “quality control” in the experiments. This is of no big shakes to Pharma who will no doubt do such replications as part of their normal development process, but perhaps speaks more to the Academic Neuros sifting through scientific rags looking for some studies to do.
Is poor reporting the main reason for the failure to translate drug treatments from animals to humans?….I really doubt it, although it will play its part.
In EAE a large part will be timings of drug delivery and doses and maybe just maybe the biology. The other major problem is Neuros, not animals, so perhaps time to look in the mirror. More on that to come.