Post on 06-May-2015
transcript
CLINIC
AL ANALY
TICS –
INNOVA
TING T
O SUPP
ORT
CLINIC
AL RESEARCH
J OH
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LI N
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CLINICAL RESEARCH INFORMATICS
Clinical Research Informatics involves
the use of informatics in the discovery and management of
new knowledge relating to health and disease.
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
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
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
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
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 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
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
PATIENT SOCIAL NETWORKS
Smartpatients.com
RECRUITMENT - APPS
Cancer Clinical Trials – Cleveland Clinic
DATA MANAGEMENT
REDCap
EMR – Get Data
CONSORTIUM
770 Institutional partnersNo cost for the software, minimal infrastructure (LAMP)Centralized support through Vanderbilt University with NIH grant support
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
DATA FROM THE EMR FOR RESEARCH
Extract clinical dataMap to standard ontologies
Cohort identification tool
Select data elements of interest
Export data set or create a registry
Update on a periodic basis
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
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
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
CONCLUSIONS
Informatics can contribute tools to every phase of clinical research
Goal – to help accelerate clinical research
National network – Clinical and Translational Science Awards
THIS PRESENTATION BASED ON MY BOOK CHAPTER “ERESEARCH” IN
Healthinformatics.org