Clinical and Translational Science: a role for libraries

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Clinical and Translational Science: a role for libraries Presented at the Science Translational Medicine Luncheon Special Libraries Association 2010 Annual Conference New Orleans, LA, on 15 June 2010. Kristi Holmes, PhD Becker Medical Library Washington University School of Medicine St. Louis, MO This work is licensed under the Creative Commons Attribution-Noncommercial-Share Alike 3.0 United States License.

Translational science Clinical and translational science initiatives have changed the face of biomedical research Scientists are increasingly aware that this bench-tobedside approach to translational research is really a two-way street. Basic scientists provide clinicians with new tools for use in patients and for assessment of their impact, and clinical researchers make novel observations about the nature and progression of disease that often stimulate basic investigations. NIH Roadmap http://nihroadmap.nih.gov/clinicalresearch/overview-translational.asp http://medschool.ucsf.edu/news/features/

Transforming clinical and translational research the CTSA program 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. 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 http://www.ncrr.nih.gov/publications/pdf/ctsa_factsheet.pdf

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/

Translational research can be defined by the two translational blocks in the clinical research continuum Sung, N. S. et al. JAMA 2003;289:1278-1287.

Coller B S, Califf R M Sci Transl Med 2009;1:10cm9-10cm9 The valley of death. Many research projects perish as researchers try to cross the rough terrain between basic discovery and useful therapy.

It takes an average of 17 years for new evidencebased 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 Collaboration can provide access to the best minds to solve the problem, and greater objectivity. Am J Med. 2003 Apr 15;114(6):477-84. 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

Translational Research Support Evaluation Oversight Statistics Publishing Informatics Core Research Facilities Libraries Clinical Trials Clinical Practice Education, Training, and Career Development Collaboration Basic Science Research Administration 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

Translational Research Support: Collaboration Publishing Core Research Facilities Clinical Practice How can libraries get involved with supporting collaboration? Let s look at two efforts, VIVO and CTSciNet. Evaluation Collaboration Oversight Libraries Basic Science Research Statistics Administration Informatics Clinical Trials Education, Training, and Career Development

Collaboration is facilitated by VIVO 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 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

With minimal effort, a VIVO profile allows a researcher to: 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. http://vivoweb.org

Who can use VIVO? and many more!

is another collaborative platform 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. 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. http://community.sciencecareers.org/ctscinet/

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 The usual stuff: Name Email Address Work Experience Education Publications Professional Affiliations Websites Area of Specialty Training/Degree

Researcher Profiling: The Wild West Many thanks to Jim Austin for this fitting description!

Researcher Profiling: The Wild West 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

Translational Research Support: Evaluation How can libraries support evaluation? Let s look at two efforts, STAR METRICS and The Becker Model for Assessment of Research Impact. Evaluation Publishing Core Research Facilities Clinical Practice Collaboration Oversight Libraries Basic Science Research Statistics Administration Informatics Clinical Trials Education, Training, and Career Development

Libraries are particularly well-poised to participate in evaluation activities Understanding the impact of research 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

A library-based example: Traditional citation analysis is insufficient to assess the impact of research discoveries 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 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? 3. What can be inferred from human and animal data about likely safety and efficacy? 4. Can the agent be delivered to its target at an adequate concentration? 5. Is there an industry partner that can develop the technology effectively and efficiently? 6. Can a pivotal study be designed and completed? 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? 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? 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? 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? 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! Publishing Core Research Facilities Clinical Practice Evaluation Collaboration Oversight Libraries Basic Science Research Statistics Administration Informatics Clinical Trials Education, Training, and Career Development