Translational Research

Translational research is the scientific research process of translating a scientific discovery back into the clinic in the form of a treatment, device, test, procedure, or process that improves patient care and treatment outcomes. Clinical research in the drug development process, in contrast, gathers critical clinical trial data for analyses. The data collected help decipher the safety and efficacy of the drug among other valuable information. The clinical research data will tell the investigators which participants are seeing efficacy and which ones are not, which participants are seeing adverse events and which do not. The root cause of why some patients see efficacy and others do not is not so easily understood with only clinical data. Demographic data collected during the process may offer hints. For instance efficacy may be found to be associated with a specific age range, race, or gender. However, even with this information, the biological and physiological reasons for efficacy vs. not require translational research activities.

Translational research, in the drug development domain, helps researchers better understand the biological and physiological difference between research subjects seeing efficacy and those that do not. Biological samples are retrieved during the clinical trial process, to be processed in laboratories, to understand these differences. They may do a variety of tests, like genotyping, on the subject samples to see if there is a variation on the target protein structures. If a specific genotype is found to be efficacious, it will be "translated" back to the clinic; it may be used to guide enrollment in further studies and even affect the final drug labeling.

The researchers at the National Center for Advancing Translational Sciences (NCAT) and the National Institute of Allergy and Infectious Diseases (NIADS) are using translational research to find new therapies for drug-resistant bacteria. They developed a high-throughput assay to screen thousands of existing drugs and drug combinations against the various bacteria. The results have translated into efficacious therapies against 12 common strains of multi-drug-resistant bacteria. On another front, a private company, Assurex Health, has translated the results from pharmacogenetics research into a five gene test for clinical depression. The results were outstanding enough the company now offers a test, Genesight, for physciatrists, to guide them to therapies specific to each individual patient based on their genotype of the five genes.

The general concept of translational research is to transfer the knowledge and insight gained in the laboratory back into the clinical setting - to improve patient care and health care outcomes. NCATS and NIADS are using the process to translate assay data back into the clinic in the form of repurposing existing therapies for the fight against drug-resistant bacteria. In the drug discovery and development processes, translational research can be used to determine the precision at which a drug works; helping guide future studies and labeling.

Berman, Jules J. Biomedical Informatics. Sudbury, MA: Jones and Bartlett, 2007. Print.

"Research on New, Rapid Screening Test Identifies Potential Therapies against Drug-resistant Bacteria | National Institutes of Health (NIH)." U.S National Library of Medicine. U.S. National Library of Medicine, n.d. Web. 11 Nov. 2016.

"Assurex Health | Our Solution." Assurex Health. N.p., n.d. Web. 11 Nov. 2016.

Hall-Flavin, Daniel K., Joel G. Winner, Josiah D. Allen, Joseph M. Carhart, Brian Proctor, Karen A. Snyder, Maureen S. Drews, Linda L. Eisterhold, Jennifer Geske, and David A. Mrazek. "Utility of Integrated Pharmacogenomic Testing to Support the Treatment of Major Depressive Disorder in a Psychiatric Outpatient Setting." Pharmacogenetics and Genomics 23.10 (2013): 535-48. Web.