Translational Medicine and Roles of Health Sciences Librarians Robyn Reed, MA, MLIS Assistant Librarian, Biomedical Informatics and Emerging Technologies “copyright friendly” version Please see citations for figures or pictures

I. Translational Medicine A.Definition B.Timeline – literature and funding II. Translational Research Example III. Librarian Roles

Translational medicine definition: “Often described as an effort to carry scientific knowledge ‘from bench to bedside,’ translational medicine builds on basic research advances - studies of biological processes using cell cultures, for example, or animal models - and uses them to develop new therapies or medical procedures.” Definition

Bench to bedside figure on Characteristics: Goal to speed research from bench to the bedside, ultimately improving human health  Usually has a team science approach (MLA News pt.1&2 summer 2013)  Multidisciplinary collaborations  Mostly clinicians and basic scientists  May also include social scientists and community collaborators

Untangling the terminology…….. Translational Medicine Translational Research Translational Science Translational research = translational science if research is scientific Using the science in practice is translational medicine

2010

There are several journals discussing translational medicine Many have the word “translational” somewhere in the title “Translational Research” - 4 Translational Research: the Journal of Laboratory and Clinical Medicine Journal of Cardiovascular Translational Research American Journal of Translational Research Drug Delivery and Translational Research “Translational Medicine” - 7 “Translational Science” - 3 Journals in Pubmed

History of Translational Medicine/Research Early mentions of the bench to bedside concept and translational research in the literature Figure 2 The exponential increase of publications on PubMed which include in their titles the term “translational research” or “translational medicine” Keramaris, N. C., Kanakaris, N. K., Tzioupis, C., Kontakis, G., & Giannoudis, P. V. (2008). Translational research: from benchside to bedside. Injury, 39(6), Currently: 457 hits 4x increase

Bench-to-Bedside (B2B) Program was launched by NIH Clinical Center  Integrate clinical and basic science research  ~700 principal investigators on 209 funded projects (through 2012)  approximately $48M (cartoon) (cartoon) (image)

image 2003 Open access journal – 2003 start

Clinical and Translational Sciences Awards CTSA Consortium  NIH-funded, Goal: move laboratory discoveries into new & better treatments to improve human health  Began in 2006 with 12 grants to academic centers  FY CTSA grants - $500 million  Currently 62 grants

CTSA Grants 62 awards across the nation in 31 states and DC Map of states with CTSA grants

National Center for Advancing Translational Sciences (NCATS/NIH) Institute designed to “enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.” CTSAs Rare Diseases Research and Therapeutics Discovering New Therapeutic Uses for Existing Molecules Tissue Chips for Drug Screening Toxicology in the 21st Century (Tox21)

Let’s take a closer look at translational research (with an example)

Translational Research – The “Ts” Figure of T0 to T4, showing the translation steps

Example modified from: Khoury MJ. et al. The continuum of translation research in genomic medicine: how can we accelerate the appropriate integration of human genomic discoveries into health care and disease prevention? Genet Med 2007:9(10): Institute of Translational Health Sciences Cited in Web of Science 215 times (November 2013)

Research PhaseTypes of ResearchResearch Example T 0 – basic scienceResearch questionAre there specific gene mutations associated with breast cancer? T 1 – humansPhase I and II clinical trials; observational studies Is there an association between BRCA mutations and breast cancer? T 2 – patientsPhase III clinical trials; observational studies; evidence synthesis and guidelines development What is the positive predictive value of BRCA mutations in at-risk women? T 3 – practicePhase IV clinical trials; dissemination research; implementation research What proportion of women who meet the family history criteria are tested for BRCA and what are the barriers to testing? T 4 – populationOutcomes research; population monitoring of morbidity, mortality, risks, and benefits Does BRCA testing in asymptomatic women reduce breast cancer incidence or improve outcomes? 1 Examples and research types modified from: Khoury MJ. et al. The continuum of translation research in genomic medicine: how can we accelerate the appropriate integration of human genomic discoveries into health care and disease prevention? Genet Med 2007:9(10): and Institute of Translational Health Scienceshttps:// Example of Translational Research 1

More Resources: Detailed figure showing the T0-T4 model Blumberg, Richard S., et al. "Unraveling the autoimmune translational research process layer by layer." Nature Medicine 18.1 (2012): Public Health Genomics example (obesity) Agurs-Collins, Tanya, et al. "Public health genomics: translating obesity genomics research into population health benefits." Obesity 16 (2008): S85-S94.

Will translational medicine improve human health? “Animal experiments, test tube analyses and early human trials do simply not reflect the patient situation well enough to reliably predict efficacy and safety of a novel compound or device. This goal, however, can only be achieved if the translational processes are scientifically backed up by robust methods some of which still need to be developed.”  Biomarkers  Statistical analyses  Accelerated human study designs  Decision algorithms Wehling, M. (2008). Translational medicine: science or wishful thinking?. Journal of translational medicine, 6(1), 31.

Barriers to Translational Research Heller, C., & de Melo-Martín, I. (2009). Clinical and Translational Science Awards: can they increase the efficiency and speed of clinical and translational research?. Academic Medicine, 84(4), Part of a figure in this paper outlining translational research barriers

Library Roles in Translational Medicine Are there clear directions?

Library Roles in Translational Medicine Libraries are already assisting in many areas Some are more obvious than others Look for new opportunities to help Understand the science The scientific research approach is changing Collaborative, team-based, multidisciplinary Porter, Alan L., and Ismael Rafols. "Is science becoming more interdisciplinary? Measuring and mapping six research fields over time." Scientometrics 81.3 (2009):

What about your institution? Stakeholders? Who is involved in translational medicine?  Clinicians / Principal investigators  Residents / Post docs  Students  Research Office  Offices that handle grants  CTSIs (if present)  Others Look for opportunities!

Anything that helps physicians or scientists do their jobs Clinical and basic science research support  Database training  Scholarly communications  Copyright  Grant writing  Citation management  NIH public access compliance  IRB – Institutional Review Board

Anything that helps physicians or scientists do their jobs Clinical and basic science research support  Data management  Institutional repositories  Data preservation/organization  Big data initiatives  PBL sessions  Curriculum development  EBM training

Anything that helps physicians or scientists do their jobs Clinical and basic science research support  Clinical trials  Electronic health records / EMR  Systematic reviews  Research networking  Health informatics  Bioinformatics / Genomics What else? List not comprehensive

Thank you! Questions? Discussion? Robyn Reed, MA, MLIS