CLINICAL RESEARCH INFORMATICS
Clinical Research Informatics involves
the use of informatics in the discovery and
managemen...
CLINICAL RESEARCH INFORMATICS
It includes management of information related to clinical trials and
also involves informati...
CLINICAL TRIALS 1.0
Study design
Collaborators
Sample size calculations
Funding
Study initiation – subject recruitment
Dat...
CLINICAL TRIALS 2.0
Exploit full use of informatics tools to:
 Create efficiency in study design and execution
 Promote ...
STUDY DESIGN
Study feasibility
Power calculations – how many patients do I need to recruit to have
enough data to get sign...
FINDING COLLABORATORS
RESEARCH SUBJECT RECRUITMENT
Research Match
EMR
Social Media
RESEARCH MATCH
RECRUITMENT FROM THE EMR
Applying inclusion/exclusion criteria to EMR
Include only active patients
When and where is their...
RECRUITMENT VIA SOCIAL MEDIA
For some studies, newspaper advertising was standard practice
Many patients now online in soc...
PATIENT SOCIAL NETWORKS
RECRUITMENT - APPS
Cancer Clinical Trials – Cleveland Clinic
DATA MANAGEMENT
REDCap
EMR – Get Data
CONSORTIUM
770 Institutional partners
No cost for the software, minimal infrastructure (LAMP)
Centralized support through ...
RESEARCH ELECTRONIC
DATA CAPTURE
Features include:
Building data collection instruments
Importing data collection instrume...
DATA FROM THE EMR FOR RESEARCH
Extract clinical data
Map to standard ontologies
Cohort identification tool
Select data ele...
DATA MAPPING
Unified Medical Language System (UMLS metathesarus)
From the National Library of Medicine
http://www.nlm.nih....
CHRONIC KIDNEY DISEASE REGISTRY
60,000 patients in the EMR
Multiple abstracts and papers from mining the data
about sympto...
From the National Institutes of Health
http://bd2k.nih.gov/
Enable biomedical scientists to capitalize more fully on the B...
CONCLUSIONS
Informatics can contribute
tools to every phase of
clinical research
Goal – to help accelerate
clinical resear...
THIS PRESENTATION BASED ON MY BOOK
CHAPTER “ERESEARCH” IN
Healthinformatics.org
Clinical analytics–innovating to support clinical research
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Clinical analytics–innovating to support clinical research

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Clinical analytics–innovating to support clinical research

  1. 1. CLINICAL RESEARCH INFORMATICS Clinical Research Informatics involves the use of informatics in the discovery and management of new knowledge relating to health and disease.
  2. 2. CLINICAL RESEARCH INFORMATICS It includes management of information related to clinical trials and also involves informatics related to secondary research use of clinical data. Clinical research informatics and translational bioinformatics are the primary domains related to informatics activities to support translational research. Profession community – America Medical Informatics Association, http://www.amia.org/applications-informatics/clinical-research- informatics
  3. 3. CLINICAL TRIALS 1.0 Study design Collaborators Sample size calculations Funding Study initiation – subject recruitment Data management/data collection Data analysis Publication/presentation Mostly on paper, labor intensive, data management a challenge
  4. 4. CLINICAL TRIALS 2.0 Exploit full use of informatics tools to:  Create efficiency in study design and execution  Promote full study recruitment  Accelerate the research process  Utilize the electronic medical record to recruit, manage data, bill appropriately and communicate
  5. 5. STUDY DESIGN Study feasibility Power calculations – how many patients do I need to recruit to have enough data to get significant results In the past – guesswork Study could proceed for 2-4 years before the investigator would find out that there were not enough patients to recruit Present and Future Compare the study inclusion/exclusion criteria with active patients in the EMR to see if the study will be successful
  6. 6. FINDING COLLABORATORS
  7. 7. RESEARCH SUBJECT RECRUITMENT Research Match EMR Social Media
  8. 8. RESEARCH MATCH
  9. 9. RECRUITMENT FROM THE EMR Applying inclusion/exclusion criteria to EMR Include only active patients When and where is their next appointment Make research nurse more efficient – go to site where several patients might be recruited in one day Essential for anesthesia/surgery research since patients must give consent prior to the day of surgery
  10. 10. RECRUITMENT VIA SOCIAL MEDIA For some studies, newspaper advertising was standard practice Many patients now online in social media, using apps, in social network communities of patients with similar diagnoses Social media still considered a form of advertising – needs to be approved by the IRB provide a link to more detailed information and who to contact Social networks of patients – must ask permission to post a trial Some patient advocates (e-Patients) may promote research
  11. 11. PATIENT SOCIAL NETWORKS
  12. 12. RECRUITMENT - APPS Cancer Clinical Trials – Cleveland Clinic
  13. 13. DATA MANAGEMENT REDCap EMR – Get Data
  14. 14. CONSORTIUM 770 Institutional partners No cost for the software, minimal infrastructure (LAMP) Centralized support through Vanderbilt University with NIH grant support
  15. 15. RESEARCH ELECTRONIC DATA CAPTURE Features include: Building data collection instruments Importing data collection instruments from a library Creating surveys for research Creating longitudinal studies Controlling user access Quality checks Exporting data for analysis Simple reports and data analysis tools
  16. 16. DATA FROM THE EMR FOR RESEARCH Extract clinical data Map to standard ontologies Cohort identification tool Select data elements of interest Export data set or create a registry Update on a periodic basis
  17. 17. DATA MAPPING Unified Medical Language System (UMLS metathesarus) From the National Library of Medicine http://www.nlm.nih.gov/research/umls/ SNOMED-CT LOINC RxNorm Mapped data easier for searching, data mining Converts raw clinical data into meaningful terms
  18. 18. CHRONIC KIDNEY DISEASE REGISTRY 60,000 patients in the EMR Multiple abstracts and papers from mining the data about symptoms, lab values, comorbidities, survival Successful grant funded by the National Institute of Health Includes demographics, lab results, procedures, encounters, vital signs, etc. Able to study disease longitudinally – data from 2005 - 2013
  19. 19. From the National Institutes of Health http://bd2k.nih.gov/ Enable biomedical scientists to capitalize more fully on the Big Data being generated by those research Grants to enable collaborative development of tools and sharing data securely for research Biomedical research enterprise is increasingly becoming data-intensive and data- driven Appropriate access to shareable biomedical data through technologies, approaches, and policies that enable and facilitate widespread data sharing, discoverability, management, curation, and meaningful re-use; Development of and access to appropriate algorithms, methods, software, and tools for all aspects of the use of Big Data, including data processing, storage, analysis, integration, and visualization; Appropriate protections for privacy and intellectual property; Development of a sufficient cadre of researchers skilled in the science of Big Data, in addition to elevating general competencies in data usage and analysis across the behavioral research workforce
  20. 20. CONCLUSIONS Informatics can contribute tools to every phase of clinical research Goal – to help accelerate clinical research National network – Clinical and Translational Science Awards
  21. 21. THIS PRESENTATION BASED ON MY BOOK CHAPTER “ERESEARCH” IN Healthinformatics.org

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