1. Translaonal Research: Hastening Research Results, Reducing Research Fraud, Protecng Paents and the New Importance of Research Data Wisconsin Health Science Librarians Associaon Annual Meeng September 21, 2012 Dorothea Salo UW-Madison School of Library & Informaon Science Allan Barclay UW-Madison Ebling Library for the Health Sciences

2. Class Outline ! Introducons ! Background: What is Translaonal Research? ! Break ! Save the Cows! ! Break ! How Librarians Can Help/Discussion/Q&A

3. Translaonal Research "Translaonal research is scienc research that facilitates the translaon of ndings from basic science to praccal applicaons that enhance human health and well-being. It is pracced in the medical, behavioral, and social sciences. Source: Wikipedia, accessed 9/19/12

4. Clinical Research Clinical research is a branch of medical science that determines the safety and eecveness of medicaons, devices, diagnosc products and treatment regimens intended for human use. These may be used for prevenon, treatment, diagnosis or for relieving symptoms of a disease. Clinical Research is dierent than clinical pracce. In clinical pracce, one used established treatments while in clinical research evidence is collected to establish a treatment. Source: Wikipedia, accessed 9/19/12

5. Clinical + Translaonal Research ! Basic research ! Speculave ! Long term, big picture ! Scaershot or uncoordinated ! Can lead to major breakthroughs, paradigm shi^s ! Applied research ! Praccal ! Short term, here & now impact ! Incremental ! Clinical + Translaonal = basic, applied + evaluaon and follow-up

6. So Why Change Anything? Houston, we have a problem need to smulate the development of novel approaches reduce cultural & administrave barriers clinical research was increasingly less aEracve to new invesgators clinician-sciensts were increasingly moving away from paent-oriented research Source: "Translaonal and Clinical Science - Time for a New Vision" - Elias A. Zerhouni, director NIH; NEJM, 335.15, October 13, 2005, p. 1621-1623

7. But Change is Hard! Houston, we really have a problem here dicules in the recruitment & retenon of human subjects in clinical trials increasingly complex resources needed to conduct modern clinical and translaonal research are either missing or scaEered their interacons were becoming more remote and dicult Source: "Translaonal and Clinical Science - Time for a New Vision" - Elias A. Zerhouni, director NIH; NEJM, 335.15, October 13, 2005, p. 1621-1623

8. OK, You Win Well Change The 3rd Roadmap Theme: Re-engineering the Clinical Research Enterprise Source: hp://www.starshipdatalink.net/enterprise/1701-ret.html

9. New Funding Models the CTSA Timeline ! 2003 NIH Roadmap for Medical Research ! 2006 CTSA program launched by NIH ! 2007 UW ICTR founded, one of 12 centers ! 2009 Program expands to 46 centers ! 2011 NCATS established to coordinate CTSA awards ! 2012 Full implementaon of 60 centers; Miami CTSI just added (61)

10. CTSA Centers Source: hp://www.ncats.nih.gov/research/cts/ctsa/about/instuons/map.html

11. How are they organized? Not the 800 lb gorilla they complement, dont compete with exisng infrastructure UW-ICTR & Marsheld Clinic, United Community Center WREN TEAM Scholars program (cohort prior to KL2 scholars) Miami CTSI funding from NCATS & Natl Instute on Minority Health and Health Disparies Each center is unique no common structure, only common goals Transformaonal goals dynamic structure

12. What do they do? Research, of course with specic targets This year is all about drug development Novel, innovave approaches Too risky, too rare for private sector support Exisng local research programs Exisng populaons Build, grow, strengthen, standardize infrastructure Educaon & professional development

13. Types of Translaonal Research T1 First phase of translaonal research, or Bench to Bedside, moves a basic discovery into a clinical applicaon T2 Bedside to Pracce research provides evidence of the value of taking the basic discovery in the clinical setng T3 Research that moves the evidence-based guidelines developed in phase 2 into health pracce; Pracce to Profession T4 Research to evaluate the real world health outcomes of the original T1 development; Profession to Public Adapted from: hp://www.michr.umich.edu/about/clinicaltranslaonalresearch

14. Type 1 Example: Experimental Mulple Sclerosis Drug BG-12 ! Biogen Idec licenses rights to develop drug in 2003 ! Clinical trials are iniated

15. Type 2 Example: Experimental Mulple Sclerosis Drug BG-12 ! Clinical trials show promise, few side eects given Fast Track designaon by FDA ! News media promote the drug discovery ! Business media promote the companys good fortune

16. Type 3 Example: Experimental Mulple Sclerosis Drug BG-12 ! If approved will likely be widely prescribed quickly recent research shows current therapies are largely ineecve, leaving a void in treatment ! Rapid, widespread adopon combined with high public prole & large number of paents will likely lead to its inclusion in clinical pracce guidelines ! Pracce guidelines will lead to changes in clinical educaon as well as pracce

17. Type 4 Example: Experimental Mulple Sclerosis Drug BG-12 ! Clinical pracce guidelines will drive use in the profession, providing a much wider basis for evaluaon of eecveness and results ! Paents taking BG-12 will be recruited for follow-up studies ! Impact in the eld will be assessed ! Based on results new drug development may occur to respond to observed issues (e.g. side eects, ineecveness in some populaons)

18. How is it dierent from tradional medical research? ! Complete lifecycle research T1 T4 T1 ! Emphasis on public health, health outcomes ! Emphasis on muldisciplinary research ! Emphasis on health equity, underserved populaons ! Fills in the gaps in tradional research pracce and infrastructure ! Aempts to create a transparent scienc environment

19. A Structural Metaphor - Pace Layering The fast parts learn, propose, and absorb shocks; the slow parts remember, integrate, and constrain. The fast parts get all the aEenon. The slow parts have all the power. Source: Brand S., "Cies and Time", The Long Now Foundaon hp://blog.longnow.org/2005/04/11/stewart-brand-cies-and-me/

20. Pace Layering Elements ! The lessons learnt and changes that occur at the outer layers, where change happens the fastest, lter down to the inner layer where change happens slowly ! The diering rates of change in each layer are likely to cause fricon between the layers ! The dierent rates of change, and resolving the resulng fricon, are benecial to the overall development of complex systems Source: The Evolving Web: A Pace Layering view of the development of the Web and the WC3, Roger Hudson, hp://www.usability.com.au/resources/evolving-web.cfm

21. The Research Enterprise - Layers ! Stareet ! Funding agencies ! Research instuons ! Researchers ! Publishers and other disseminators ! Professional sociees (pracce guidelines, accreditaon) ! Clinicians ! The public

22. Why, yes, I am a hopeless opmist! Source: hp://dollydileante.blogspot.com/2007/10/all-about-pollyanna.html

23. End Part I

24. Part III Opportunies for Librarians

25. The tradional ! Lit searching general & now for compliance issues ! Database experse ! Reference & instrucon ! Current awareness services (RSS, TOC, etc.)

26. Scholarly communicaon ! PMCID, NIHMSID, grant numbers & acknowledgment ! Repositories ! Journal publicaon selecon ! Open Access issues

27. Altmetrics ! Twier ! Blogs ! Social literature tools - Mendeley, Papers ! News sources

28. Clinical trials ! Clinicaltrials.gov & the usual suspects ! Local clinical trials recruing, lisngs ! Cohort selecon ! hp://i2b2.org - Informacs for Integrang Biology and the Bedside ! Taxonomy development done by librarians! Who look like Lisbeth Salander!

29. Funding ! Finding sources of funding ! Grants.gov ! Non-governmental sources (e.g. foundaons, programs) ! Local sources (e.g. healthcare instuons, CTSA centers) ! Help with grants (background research, data plans)

30. Informacs ! Electronic medical records ! Tools to help (semi) automate other tasks like publicaon tracking, nding funding, etc

31. CTSA Instuonal Navigator ! Crappy website gurer-outer ! Matchmaker ! Neutral 3rd party ! Instuonal memory

32. Educaon & Awareness ! CTSA center opportunies nding and promong ! Library instrucon ! Research data issues & awareness

33. And now for something completely dierent