„The CNR is an independent interdisciplinary research center aiming to collect, analyze and evaluate world-wide scientific knowledge available on innovative, competitive and complementary therapeutic approaches in the field of traumatic injuries and degenerative diseases of the central nervous system. We aim to enhance and profoundly speed up the process of translation of experimental therapies into the clinics – and thus to the patient.“
— Prof. Hans Werner Müller, founder of the CNR.
As scientific knowledge and technology improves world-wide, a vast and exponentially increasing amount of scientific publications on therapy development for neurological diseases is accessible today. This preclinical data should be the basis for a comprehensive choice of therapeutical concepts entering clinical trials.
Clinical trials for neurological diseases in general, and spinal cord injury in particular, are highly complex, time consuming and expensive.
Therefore, only limited numbers of clinical trials can be performed in a given time, rendering the selection of the most promising therapeutic preclinical approaches a very important and crucial task. It holds true that the choice for one therapy entering clinical testing decreases the chances for other potential therapies, or even completely prevents competitive approaches. It is important to note, that the wrong decision for a trial therapy candidate, may delay the development of other eventually more promising therapies. Whenever possible, false decisions at this point should be avoided, because they could be useless or, in the worst case, dangerous or even life-threatening for patients.
Although information technology (IT) is rapidly advancing, scientific publications are still manually evaluated and compared by biomedical researchers, a method which becomes increasingly inefficient as exemplified for therapy development of traumatic central nervous system (CNS) injury and repair.
John Naisbitt, 1982
We are drowning in information,
but starved for knowledge.
The problem of
Knowledge retrieved by scientific experiments is valuable if shared with the scientific community. Therefore, scientific achievements and new insights into pathological processes as gained by laboratory experiments are usually published in one of approximately 500 neuroscientific journals. For the example of spinal cord and brain injury, almost 140,000 scientific papers can be retrieved in PubMed® or GoPubMed®, respectively, which are public biomedical citation management systems.
The number of citations rose rapidly over the last 20 years and reached around 8,000 new publications in the year 2011. This means, that a neuroscientist working on the development for therapies on CNS trauma would have to read 22 scientific publications (approximately 22 hours reading) every day in 2011 and store the knowledge of these papers in a mental or physical database (plus additional time for data input), which is obviously impossible. Therefore, a technical solution for information management supporting neuroscience researchers must be found and seems feasible regarding current developments in information technology.
A question of
Besides the hurdle of the huge flood of scientific information, there is the problem of defining the clinical relevance, feasibility, reliability and prospect success of therapeutic concepts.
Which prerequisites should be sufficient for a therapeutic approach to enter a clinical trial?
Even today, in the age of rapid digital communication, it seems difficult to agree on a common judgement regarding the efficacy and relevance of an experimental therapy. Very recently, a group of neuroscientists in North America published the first paper on this issue regarding a grading system for preclinical therapies in spinal cord injury.
Taken from: Kwon BK et al. (2011) A grading system to evaluate objectively the strength of pre-clinical data of acute neuroprotective therapies for clinical translation in spinal cord injury. J Neurotrauma. 28:1525-43.
All concepts described in this publication were agreed upon by a council of scientific experts in this field. Nevertheless, to accomplish all the requested demands (e.g. independent reproduction of results, repetition in different animal species etc) is not easy for a single laboratory. As for the reproduction of experiments, it is highly problematic to find laboratories willing to spend time and resources to reproduce and confirm previously published results which are almost impossible to publish. Therefore, an independent institution for this purpose is mandatory to speed up the process of clinical translation.
delayed development of therapies
This is also the case for other neurodegenerative CNS diseases, such as multiple sclerosis (MS), M. Parkinson, M. Alzheimer or stroke. There are about 2.5 Mio. patients worldwide suffering from MS, about 8 Mio. Parkinson patients and at least 20 Mio. Alzheimer patients (in Germany: 130,000 MS, 350,000 Parkinson and 1 Mio. Alzheimer patients). Every year about 200,000 people in Germany suffer from stroke which is the third-most cause of death.
The CNR will first start with traumatic spinal cord injury and paraplegia to paradigmatically use and transfer knowledge for the research and treatment of other neurodegenerative diseases with similar final pathogenetic mechanisms. Therefore, it is a socio-political and economic task of highest priority to promote promising R&D-projects in the field of neuronal regeneration through the fast and efficient installation of the CNR.
A bridge between basic science and clinics:
The CNR is an independent interdisciplinary research center aiming to collect, analyze and evaluate world-wide scientific knowledge available on innovative, competitive and complementary therapeutic approaches in the field of traumatic injuries and degenerative diseases of the central nervous system. In this way, the most promising therapies for spinal cord injury, traumatic brain injury, multiple sclerosis, stroke as well as neurodegenerative diseases such as Morbus Parkinson and Morbus Alzheimer will be identified and selected from the overwhelming amount of scientific reports.
The CNR will collect and pre-process worldwide scientific preclinical data on neuroregenerative therapies (CNR Information Center). This data will be analyzed, evaluated and made accessible to the scientific community to increase the level of knowledge of neuroscience researchers, clinicians, funding organizations and biopharmaceutical companies. By sorting and evaluating these data in a standardized way, the assessment of a level of evidence for almost all preclinical approaches published is, for the first time, feasible.