MLA CE class on Clinical Translational Research for WHSLA annual conference in 2012. Co-presented with Dorothea Salo.
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Transla’onal Research: Hastening Research Results, Reducing Research Fraud, Protec’ng Pa’ents and the New Importance of Research Data Wisconsin Health Science Librarians Associa’on Annual Mee’ng – September 21, 2012 Dorothea Salo UWMadison School of Library & Informa’on Science Allan Barclay UWMadison Ebling Library for the Health Sciences
Transcript
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)
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