Kristi Holmes, PhDBecker Medical Library

Washington University School of Medicine

St. Louis, MO

Clinical and Translational Science: a role for libraries

Presented at the Science Translational Medicine LuncheonSpecial Libraries Association 2010 Annual Conference

New Orleans, LA, on 15 June 2010.

This work is licensed under the Creative Commons Attribution-Noncommercial-Share Alike 3.0 United States License.

Translational science

Scientists are increasingly aware that this bench-to-bedside approach to translational research is really atwo-way street. Basic scientists provide clinicians withnew tools for use in patients and for assessment oftheir impact, and clinical researchers make novelobservations about the nature and progression ofdisease that often stimulate basic investigations.

NIH Roadmap http://nihroadmap.nih.gov/clinicalresearch/overview-translational.asp

http://medschool.ucsf.edu/news/features/

Clinical and translational science initiatives have changed the face

of biomedical research

Transforming clinical and translational research – the CTSA program

http://www.ncrr.nih.gov/publications/pdf/ctsa_factsheet.pdf

To set a national research agenda, CTSA consortium leaders have identified five overarching strategic goals that will guide consortium-wide activities:

Goal 1: Build national clinical and translational research capability

Goal 2: Provide training and improve career development of clinical and translational scientists

Goal 3: Enhance consortium-wide collaborations

Goal 4: Improve the health of our communities and the nation

Goal 5: Advance T1 translational research to move basic laboratory discoveries and knowledge into clinical testing

The CTSA program creates academic homes for clinical and translational science at research institutions across the country. A major goal of the program is to develop teams of investigators from various fields of research who can take scientific discoveries in the laboratory and turn them into treatments and strategies for patients in the clinic. By encouraging collaboration across disciplines, CTSAs use innovative approaches to tackle research challenges and train clinical and translational researchers.

Clinical and translational science is a bit like the London Underground

Intersections of people and roles across the research continuum from clinical, research, administrative and support perspectives

http://www.tfl.gov.uk/

Sung, N. S. et al. JAMA 2003;289:1278-1287.

Translational research can be defined by the two translational blocks in the clinical research continuum

The “valley of death.” Many

research projects perish as

researchers try to cross the

rough terrain between basic

discovery and useful therapy.

Coller B S , Califf R M Sci Transl Med 2009;1:10cm9-10cm9

It takes an average of 17 years for new evidence-

based findings to be knowledge to be

incorporated into clinical practice

Yearbook of Medical Informatics 2000;65-70.

Milestones for 32 interventions

Contopoulos-Ioannidis, et al. Science 2008 321(5894):1298-9.

How do we accelerate the process?

Collaboration is key!

http://autoshow.roadfly.com/wp-content/gallery/2009-nissan-maxima/nissan-maxima-speedometer-dash.jpg

An example of the importance of collaboration

Am J Med. 2003 Apr 15;114(6):477-84.

Collaboration can provide access to the best minds to solve the

problem, and greater objectivity.

From: http://becker.wustl.edu/impact/assessment/strategies.html

The effect of team research on phases of innovation

Disis M L , Slattery J T Sci Transl Med 2010;2:22cm9-22cm9

Libraries

Core Research Facilities

Clinical Practice

Collaboration

Basic Science Research

Administration

Education, Training, and

Career DevelopmentClinical Trials

Informatics

Statistics

Oversight

Evaluation

Publishing

Translational Research Support

Libraries can play an important role in a number of efforts that support and facilitate translational science.

We’ll investigate two of these areas of interest in more detail

• Collaboration

• Evaluation

Libraries

Core Research Facilities

Clinical Practice

Collaboration

Basic Science Research

Administration

Education, Training, and

Career DevelopmentClinical Trials

Informatics

Statistics

Oversight

Evaluation

Publishing

Translational Research Support: Collaboration

How can libraries get involved with supporting collaboration? Let’s look at two efforts, VIVO and CTSciNet.

Collaboration is facilitated by VIVO

• Originated at Cornell University

• Development now funded by $12.2 million NIH grant

• Seven founding members of VIVO Collaboration—Cornell University, University of Florida, Weill Cornell Medical College, Indiana University, Washington University in St. Louis School of Medicine, The Scripps Research Institute, Ponce School of Medicine

• For more information visit http://vivoweb.org

• Open source semantic web application, ontology editor, content management system

• Enables discovery of research across an institution• Contains detailed profiles of scholars and researchers• Profiles contain contact information, lists of publications, grants, research

interests, teaching, awards, and more• Data can be ingested from authoritative sources and/or manually entered• Library-based support model

Illustrate academic, social, and research networks.

Showcase special skills or expertise.

Establish connections and communities within areas of research areas and geographic expertise

Summarize credentials and professional accomplishments.

Publish the URL or link the profile to other applications.

With minimal effort, a VIVO profile allows a researcher to:

http://vivoweb.org

Who can use VIVO?

…and many more!

In CTSciNet you can…– Network and have discussions

with other scientists, including peers, mentors, and protégés.

– Join virtual groups on specific subjects or for specific organizations.

– Read articles and find specific information on navigating a career in clinical or translational research and on career development.

– Access information and resources from our partner organizations.

CTSciNet, the Clinical and Translational Science Network, is an

online community for people interested in or already pursuing

careers in clinical and translational research.

Their goal is to help people help each other to develop rewarding

careers in clinical and translational science while expanding America's clinical and translational research

capacity.

http://community.sciencecareers.org/ctscinet/

is another collaborative platform

• The information contained in a CTSciNet profile is similar to information in other profiling platforms –including VIVO

• Collaboration is an ideal opportunity

• AAAS technical services team and the technical team at VIVO

Work Experience

Education

Publications

Professional Affiliations

Websites

Area of Specialty

Training/Degree

The usual stuff:NameEmail

Address

Researcher Profiling: The Wild West

Many thanks to Jim Austin for this fitting description!

• Really? The Wild West?– There are currently no

standards for profiling platforms

– Profiling platforms aren’t compatible with each other

– This field is quickly changing

• VIVO – Open platform with inertia

– Federated approach, easily distributed

– Sophisticated, searchable system of profiles

VIVO and CTSciNet partnership• If a researcher has a VIVO profile

and wants to participate in CTSciNet, the researcher will be able to be able to easily populate their CTSciNet profile with data from VIVO

• Little additional entering of information

• Information is available for viewing and searching

• Great time savings

• Supports a standard approach

Researcher Profiling: The Wild West

Libraries

Core Research Facilities

Clinical Practice

Collaboration

Basic Science Research

Administration

Education, Training, and

Career DevelopmentClinical Trials

Informatics

Statistics

Oversight

Evaluation

Publishing

How can libraries support evaluation? Let’s look at two efforts, STAR METRICS and The Becker Model for Assessment of Research Impact.

Translational Research Support: Evaluation

Libraries are particularly well-poised to participate in evaluation activities

STAR METRICS Science and Technology in America’s Reinvestment – Measuring the EffecT of

Research on Innovation, Competitiveness and Science

• Multi-agency initiative (NSF, NIH, White House Office of Science Technology and Policy)

• Two phases:– Phase I: The development of uniform, auditable and standardized

measures of the initial impact of ARRA and science spending on job creation.

– Phase II: The collaborative development of measures of the impact of federal science investment in four broad categories:

• Economic growth (through patents, firm start ups and other measures),• Workforce outcomes (through student mobility and employment),• Scientific knowledge (such as publications and citations) and, later,• Social outcomes (such as health and environment)

http://sites.nationalacademies.org/PGA/fdp/PGA_057189

Understanding the impact of research

A library-based example:

Becker Model for Assessment of Research Impact

Included are:– guidelines for quantifying and

documenting research impact – resources for locating evidence of

research impact. – strategies that investigators can utilize in

order to enhance the diffusion of research output

• Impact can be evaluated for individual papers, individual investigators or departments, and even institutes and entire institutions.

• Assessing the impact of CTSA-funded research at WUSM

• From Becker Medical Library

Traditional citation analysis is insufficient to assess the impact of research discoveries

http://becker.wustl.edu/impact/assessment/index.html

Libraries can also bring expertise and resources to help answer questions related to issues affecting the success of translational research projects:

Category Evaluation questions

1. Is it worth the effort? Does the new technology’s intended use address a compelling health need?Is the scientific rationale strong, and does it suggest a possible medical benefit when compared with existing therapies?

2. Is there an adequate potential commercial market?

Does the size and type of market indicate a high likelihood of economic viability?Is the intellectual property protection solid?Is the technology likely to be cost-effective?

3. What can be inferred from human and animal data about likely safety and efficacy?

Is there a human genetic disorder that affects the therapeutic target?If so, does the phenotype support the efficacy and/or safety of the agent?Are the animal models used to assess efficacy and safety convincingly representative of the human disease?

4. Can the agent be delivered to its target at an adequate concentration?

Are the pharmacokinetics and pharmacodynamics acceptable for the intended use, based on direct assessment of the effects on the target molecule or meaningful functional assays?

5. Is there an industry partner that can develop the technology effectively and efficiently?

Is there an industry partner willing to make the development program a high priority?Will the industry partner ensure that the preclinical and clinical development groups exchange ideas throughout the development process?Is there an industry partner that will refrain from excessive secrecy?Can the technology be manufactured easily and at a reasonable price?

6. Can a pivotal study be designed and completed?

Can a study be designed with a medically meaningful endpoint?Can the study be designed to reflect clinical equipoise and be attractive to both participants and their clinicians?Can a study be designed with sufficient statistical power to detect the endpoint?

Coller B S , Califf R M Sci Transl Med 2009;1:10cm9-10cm9

What can I do to support these types of initiatives on my campus?

• Identify user groups and efforts

• Identify key national initiatives – Read commentary, perspectives and notes sections of journals (Science, Science

Translational Medicine, Nature, and PLoS One)

– Subscribe to RSS feeds of NIH news releases, tables of contents, and blogs

• Identify campus-wide initiatives related to clinical and translational science– How can we get involved? What can we do for them? What expertise can we bring to the

table?

• Identify the information gap and fill it!

• Make friends and talk to people – go to seminars and workshops on campus

• Offer training opportunities, host vendor training events

• Give talks on campus in departmental meetings, lecture series, workshops

• Connect with other libraries to share ideas and collaborate

Clinical and Translational Science Support

Where do today’s medical libraries fit?

Everywhere!

Libraries

Core Research Facilities

Clinical Practice

Collaboration

Basic Science Research

Administration

Education, Training, and

Career DevelopmentClinical Trials

Informatics

Statistics

Oversight

Evaluation

Publishing