Transcript Document

Managing Disparate Data Generated from Translational Research Activities: iClinical Implementation to
Support Data Integration and Sharing for the IPCP
Jeffrey S. Barrett, Kalpana Vijayakumar, Sundararajan Vijayakumar, Dimple Patel, Mahesh Narayan, Bhuvana Jayaraman, Erin Cummings, Steven Douglas
Laboratory for Applied PK/PD, Division of Clinical Pharmacology, The Children’s Hospital of Philadelphia, PA
BACKGROUND
DESIGN AND METHODS
 Sharing data is an essential part of current multidisciplinary research
program supported by the NIH and has defined the need for integrated
data solutions for many academic medical research programs.
 The Integrated Preclinical Clinical Program (IPCP) is an NIH
grant mechanism that supports preclinical to clinical investigations for
the discovery and development of new therapeutics targets for HIV
infection.
 The program consists of three cores with four inter-related projects.
Core A serves as an administrative core. Core B provides HIV
antiretroviral drug susceptibility and drug Interactions. Core C
provides biostatistics and pharmacology.
The four projects to identify neurokinin-1 receptor (NK1- R)
antagonist for HIV therapy are recognized by number.
 Project 1 investigates the mechanisms involved in the NK-1R
substance P (SP) preferring receptor, antagonist-mediated anti-HIV
activity in human immune cells.
 Project 2 investigates the anti-viral, molecular and cellular
immunologic mechanisms.
 Project 3 investigates the SIV disease progression, effects of SP
level, and neurophysiologic and neurobehavioral studies in Rhesus.
 Project 4 investigates the safety, viral suppressive potential,
pharmacokinetics in HIV-infected individuals and immune modulatory
effects of treatment with aprepitant.
 The program generates a large number of translational data from all
four projects including basic science, PK/PD, safety and efficacy,
laboratory, protocol, and in vitro/in vivo data in addition to reports and
documents obtained from these experiments.
 To comply with NIH data sharing requirements, an integrated data
environment, iClinical, has been developed as a web-based tool to
provide secure data storage, data sharing, analysis, and reporting
capabilities.
iClinical is an integrated data solution that can accommodate in-vitro,
in-vivo and human clinical trial data at multiple levels of granularity
and organization. Figure 1 shows the various component tiers. Figure
2 shows the summary of IPCP project data flow diagram into iClinical
System and shows the modules for input of new data to pull together
loosely coupled study data or supportive experimental data, and results
from mathematical data analysis and predictive modeling.
OBJECTIVES
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DESIGN AND METHODS
Figure 2: IPCP-iClinical Overview
RESULTS
Pilot data from IPCP Projects 1 & 2 are analyzed in iClinical and
accessible via the web.
Figure 1: iClinical Component Tiers
• The system integrates and cross-links data from the above streams
and making them available for drill down analysis within a study,
meta-analysis across studies, data summarization and generation of
tables and listings for reports.
• Data imported into iClinical is defined by association with
corresponding data items in the central data dictionary. This allows
users the ability to map multiple user defined dictionaries into one
central dictionary or to external standards such as the CDISC.
• Benefits include the ability to define derived columns, unit
standardization, enforcement of allowed values, translation of data
coding tables into allowed values and most importantly enabling
meta-analysis across studies and predictive results.
• The data that is mapped into the dictionaries can then be summarized
and viewed via any number of canned reporting templates or one
created on the fly.
RESULTS
Using iClinical
• Preparing the data files is as simple as preparing data in ASCII comma
To effectively capture IPCP translational data, protocols and define
separated value (.csv) or MS Excel file.
the framework for comprehensive data collection.
• The uploaded files are captured as-is with appropriate date/time stamps,
Enforce metadata and dictionary standards right at the source and/or
data ownership and versioning as well as parsed into the central data
allow them to be mapped between systems
mart for easy searching. Access to data within iClinical is password
Route the data for review and approval and notify data consumers
protected and made available for browsing, updating, reporting,
and project team alike
exporting or importing based on the roles granted to each user.
Standardize the data and results to enable meta-analysis across studies • iClinical is accessible via the web in a secure encrypted session fully
Provide analysis ready datasets and track results from analysis.
compliant with the Code of Federal Regulations, 21-CFR-11.
Figure 3. User’s have an option to filter by Figure 4. Shows the plots by selected
dataset with variable of interest and stratify drug and subgroups.
plot types on available subgroups.
* Various views of the IPCP data in iClinical system
CONCLUSIONS
 The IPCP-iClinical web interface will serve as a common platform to bring
translational research data across projects from different institutions and
streamlines the data capture process and efficiently stores research data for
public data sharing, analysis and reporting.
 Centralized data and document storage, automated routing for review,
correction and approval, capture interim data status, export raw data and
import analytical results, gate access to entire study or sub-domain of study
while limiting user operations on such data.
 iClinical thus promotes collaborative study engagement both within the
organization and external collaborators, including project sponsors such as
the NIH and gated access to the broader research community.
 The solution is easily accessible over the web and provides secure and
encrypted access for both internal users and external sponsors, collaborators
and the NIH.