Translaonal	  Research:	  Hastening	   Research	  Results,	  Reducing	  Research	  Fraud,	  Protecng	  Paents	  and	  the	...
Class	  Outline            	  	  !     Introducons	  !     Background:	  What	  is	  Translaonal	  Research?	  !     Break...
Translaonal	  Research	  "Translaonal	  research	  is	  scienfic	  research	  that	  facilitates	  the	  translaon	  of	  fi...
Clinical	  Research	  “Clinical	  research	  is	  a	  branch	  of	  medical	  science	  that	  determines	  the	  safety	 ...
Clinical	  +	  Translaonal	  Research	  !   Basic	  research	      !     Speculave	      !     Long	  term,	  big	  pictur...
So	  Why	  Change	  Anything?	                                      Houston,	  we	  have	  a	  problem	  	  “…need	  to	  ...
But	  Change	  is	  Hard!	                    Houston,	  we	  really	  have	  a	  problem	  here	  	  “…difficules	  in	  th...
OK,	  You	  Win	  –	  We’ll	  Change	              The	  3rd	  Roadmap	  Theme:	  Re-­‐engineering	  the	  Clinical	  Rese...
New	  Funding	  Models	  –	  the	  CTSA	                                   Timeline	                                      ...
CTSA	  Centers	  Source:	  hp://www.ncats.nih.gov/research/cts/ctsa/about/instuons/map.html	  
How	  are	  they	  organized?	  •  Not	  the	  800	  lb	  gorilla	  –	  they	  complement,	  don’t	     compete	  with	  e...
What	  do	  they	  do?	  •  Research,	  of	  course	  –	  with	  specific	  targets	      –  This	  year	  is	  all	  about...
Types	  of	  Translaonal	  Research	  T1	  –	  First	  phase	  of	  translaonal	  research,	  or	  “Bench	  to	  Bedside,”...
Type	  1	    Example:	  Experimental	  Mulple	  Sclerosis	  Drug	  BG-­‐12	                                           	  !...
Type	  2	         Example:	  Experimental	  Mulple	  Sclerosis	  Drug	  BG-­‐12	  	  !   Clinical	  trials	  show	  promis...
Type	  3	    Example:	  Experimental	  Mulple	  Sclerosis	  Drug	  BG-­‐12	                                               ...
Type	  4	   Example:	  Experimental	  Mulple	  Sclerosis	  Drug	  BG-­‐12	                                            	  !...
How	  is	  it	  different	  from	  tradional	                     medical	  research? 	  	  !   Complete	  lifecycle	  rese...
A	  Structural	  Metaphor	  -­‐	  Pace	  Layering	  	  “The	  fast	  parts	  learn,	  propose,	  and	  absorb	  shocks;	  ...
Pace	  Layering	  Elements	  !   The	  lessons	  learnt	  and	  changes	  that	  occur	  at	  the	  outer	      layers,	  ...
The	  Research	  Enterprise	  -­‐	  Layers	  !   Starfleet	  !   Funding	  agencies	  !   Research	  instuons	  !   Researc...
Why,	  yes,	  I	  am	  a	  hopeless	  opmist!	   Source:	  hp://dollydileante.blogspot.com/2007/10/all-­‐about-­‐pollyanna...
End	  Part	  I	  
Part	  III	  –	  Opportunies	  for	  Librarians	  
The	  tradional	   	  	  !   Lit	  searching	  –	  general	  &	  now	  for	  compliance	      issues	  !   Database	  expe...
Scholarly	  communicaon	  !   PMCID,	  NIHMSID,	  grant	  numbers	  &	      acknowledgment	  !   Repositories	  !   Journa...
Altmetrics	  !     Twier	  !     Blogs	  !     Social	  literature	  tools	  -­‐	  Mendeley,	  Papers	  !     News	  sourc...
Clinical	  trials	  ! Clinicaltrials.gov	  &	  the	  usual	  suspects	  !   Local	  clinical	  trials	  –	  recruing,	  li...
Funding	                                      	  !   Finding	  sources	  of	  funding	      ! Grants.gov	      !  Non-­‐go...
Informacs	  	  !   Electronic	  medical	  records	  !   Tools	  to	  help	  (semi)	  automate	  other	  tasks	  like	     ...
“CTSA	  Instuonal	  Navigator”	  !     Crappy	  website	  figurer-­‐outer	  !     Matchmaker	  !     Neutral	  3rd	  party	...
Educaon	  &	  Awareness	  !   CTSA	  center	  opportunies	  –	  finding	  and	      promong	  !   Library	  instrucon	  !  ...
And	  now	  for	  something	  completely	                   different… 	  	  
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Translational researchfinal4whsla

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MLA CE class on Clinical Translational Research for WHSLA annual conference in 2012. Co-presented with Dorothea Salo.

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Translational researchfinal4whsla

  1. 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. 2. Class  Outline    !   Introducons  !   Background:  What  is  Translaonal  Research?  !   Break  !   Save  the  Cows!  !   Break  !   How  Librarians  Can  Help/Discussion/Q&A  
  3. 3. Translaonal  Research  "Translaonal  research  is  scienfic  research  that  facilitates  the  translaon  of  findings  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. 4. Clinical  Research  “Clinical  research  is  a  branch  of  medical  science  that  determines  the  safety  and  effecveness  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  different  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. 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. 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. 7. But  Change  is  Hard!   Houston,  we  really  have  a  problem  here    “…difficules  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  difficult…”     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. 8. OK,  You  Win  –  We’ll  Change   The  3rd  Roadmap  Theme:  Re-­‐engineering  the  Clinical  Research  Enterprise   Source:  hp://www.starshipdatalink.net/enterprise/1701-­‐refit.html  
  9. 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. 10. CTSA  Centers  Source:  hp://www.ncats.nih.gov/research/cts/ctsa/about/instuons/map.html  
  11. 11. How  are  they  organized?  •  Not  the  800  lb  gorilla  –  they  complement,  don’t   compete  with  exisng  infrastructure   –  UW-­‐ICTR  &  Marshfield  Clinic,  United  Community  Center   –  WREN   –  TEAM  Scholars  program  (cohort  prior  to  KL2  scholars)   –  Miami  CTSI  –  funding  from  NCATS  &    Nat’l  Instute  on   Minority  Health  and  Health  Disparies  •  Each  center  is  unique  –  no  common  structure,  only   common  goals  •  Transformaonal  goals  è  dynamic  structure  
  12. 12. What  do  they  do?  •  Research,  of  course  –  with  specific  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. 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. 14. Type  1   Example:  Experimental  Mulple  Sclerosis  Drug  BG-­‐12    ! Biogen  Idec  licenses  rights  to  develop  drug  in  2003  !   Clinical  trials  are  iniated  
  15. 15. Type  2   Example:  Experimental  Mulple  Sclerosis  Drug  BG-­‐12    !   Clinical  trials  show  promise,  few  side  effects  –  given   Fast  Track  designaon  by  FDA  !   News  media  promote  the  drug  discovery  !   Business  media  promote  the  company’s  good   fortune  
  16. 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   ineffecve,  leaving  a  void  in  treatment  !   Rapid,  widespread  adopon  combined  with  high   public  profile  &  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. 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  effecveness  and  results  !   Paents  taking  BG-­‐12  will  be  recruited  for  follow-­‐up   studies  !   Impact  “in  the  field”  will  be  assessed  !   Based  on  results  new  drug  development  may  occur   to  respond  to  observed  issues  (e.g.  side  effects,   ineffecveness  in  some  populaons)  
  18. 18. How  is  it  different  from  tradional   medical  research?    !   Complete  lifecycle  research  –  T1  è  T4  è  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  scienfic   environment  
  19. 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. 20. Pace  Layering  Elements  !   The  lessons  learnt  and  changes  that  occur  at  the  outer   layers,  where  change  happens  the  fastest,  filter  down   to  the  inner  layer  where  change  happens  slowly  !   The  differing  rates  of  change  in  each  layer  are  likely  to   cause  fricon  between  the  layers  !   The  different  rates  of  change,  and  resolving  the   resulng  fricon,  are  beneficial  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. 21. The  Research  Enterprise  -­‐  Layers  !   Starfleet  !   Funding  agencies  !   Research  instuons  !   Researchers  !   Publishers  and  other  disseminators  !   Professional  sociees  (pracce  guidelines,   accreditaon)  !   Clinicians  !   The  public  
  22. 22. Why,  yes,  I  am  a  hopeless  opmist!   Source:  hp://dollydileante.blogspot.com/2007/10/all-­‐about-­‐pollyanna.html  
  23. 23. End  Part  I  
  24. 24. Part  III  –  Opportunies  for  Librarians  
  25. 25. The  tradional      !   Lit  searching  –  general  &  now  for  compliance   issues  !   Database  experse  !   Reference  &  instrucon  !   Current  awareness  services  (RSS,  TOC,  etc.)  
  26. 26. Scholarly  communicaon  !   PMCID,  NIHMSID,  grant  numbers  &   acknowledgment  !   Repositories  !   Journal  publicaon  selecon  !   Open  Access  issues  
  27. 27. Altmetrics  !   Twier  !   Blogs  !   Social  literature  tools  -­‐  Mendeley,  Papers  !   News  sources  
  28. 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. 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. 30. Informacs    !   Electronic  medical  records  !   Tools  to  help  (semi)  automate  other  tasks  like   publicaon  tracking,  finding  funding,  etc  
  31. 31. “CTSA  Instuonal  Navigator”  !   Crappy  website  figurer-­‐outer  !   Matchmaker  !   Neutral  3rd  party  !   Instuonal  memory  
  32. 32. Educaon  &  Awareness  !   CTSA  center  opportunies  –  finding  and   promong  !   Library  instrucon  !   Research  data  issues  &  awareness  
  33. 33. And  now  for  something  completely   different…    

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