CLINIC

AL ANALY

TICS –

INNOVA

TING T

O SUPP

ORT

CLINIC

AL RESEARCH

J OH

N S

HA

RP

, MG

R, C

LI N

I CA

L R

ES

EA

RC

H I N

FO

RM

AT

I CS

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