ODC-TBI and PRECISE resources for in silico research: navigating the new NIH policy on using animals in research

By now the implications of the new NIH policy on the use of animals in research–that it will no longer develop new funding opportunities focused exclusively on animal models of human disease– are reverberating across the preclinical neurotrauma community. Going forward, new funding opportunities will require consideration of  various approaches that fall broadly under the category of NAMs.  What are NAMs?  The official NIH report states that they are Novel Alternative Methods also defined as  New Approach Methodologies, Non-Animal Methods, or New Alternative Methods. Whatever the exact definition, the intent is clear; NIH is looking for breakthroughs in methodologies to complement or replace animal studies. Such methods include in silico (computational), in chemico (molecules) or in vitro approaches (cells). Animal models may still be used, but in conjunction with these types of methods. 

Why is this change coming?  The NIH politely notes that “Some bodies of research have been inconclusive on the efficacy of translating the results of animal models to human diseases, such as Alzheimer’s disease and cancer.” In other words, our current translational approaches have not worked well, if at all. Unfortunately, we know this situation holds true for preclinical neurotrauma as well. Putting a positive spin on it, NIH states that this strategy, rather than being restrictive or prescriptive,  is intended to expand the toolbox for preclinical research so researchers can answer previously difficult or unanswerable biomedical research questions. The NIH intends to establish the Office of Research Innovation, Validation, and Application (ORIVA) within NIH’s Office of the Director to help manage this transition, including programs for evaluation, dissemination and funding for NAMs approaches. 

So how can the ODC-TBI and PRECISE-TBI help?

As you can see in the accompanying figure from the official report, interoperable and reliable datasets form a key pillar of the envisioned ecosystem. In silico methods, whether data-driven or modeling-based,  will require copious amounts of reliable data and multidisciplinary teams that bring together data science, computational, domain and clinical expertise.  The ODC-TBI can serve as a community platform for hosting data generated through NAMS and related methods - indeed we are already starting to see some types of NAMs come through the early stages of the pipeline.  These datasets can serve as a valuable resource for those embarking on new model systems.  PRECISE-TBI is leading the way in developing the necessary standards for interoperable and high quality datasets and can extend these approaches to existing and new in silico, in chemico and in vitro model systems.  NAMS can be added to our existing Model Catalog to make this information available for query and to disseminate standardized information about studies using them through the Model Catalog. PRECISE-TBI  can support training within the preclinical community and access to data scientists specializing in neurotrauma, including working with clinical data, to support the community.  

But, of greater importance,  the ODC-TBI was founded on the belief that successful translation in neurotrauma will be data driven,  taking advantage of advances in data science, most recently AI,  to probe large, heterogeneous subject level datasets for multidimensional patterns that hold across species, including humans. The ODC-TBI currently makes available subject level data from thousands of animals in analysis ready form, waiting to be exploited. The use of existing data and new analysis methods to ask and answer questions that could not be addressed through in vivo research alone falls exactly within the scope of the new policy.  

Thus, the  ODC-TBI becomes not just an end point for data sharing, but a starting point for TBI research,  Researchers will be able to dive into a growing body of  multi-species, multi-model and multi-modal data to suggest better experimental designs, look for cross-species correlations, and develop new hypotheses. These hypotheses can then be tested in clinical datasets or carried back to the laboratory for further validation, including animal studies. 

We’d love to hear your thoughts about the new policy and invite you to share your comments below.  We’d also like you to help us help you by letting us know what would be most useful to you as you manage this transition.  Please take a few minutes to answer our survey. 

Onwards!

Reposted from ODC-TBI.org