Building a Homegrown Data Management System:
Perspectives from the HALT-PKD Trials
Kaleab Z. Abebe
Assistant Professor of Medicine, Biostatistics, and Clinical & Translational Sciences Center for Research on Health Care Data Center
University of Pittsburgh School of Medicine
1 Overview of HALT-PKD
2 “On the fly fixes”
Outcome Adjudication Master Regulatory File
3 Conclusions
1 Overview of HALT-PKD
2 “On the fly fixes” Outcome Adjudication Master Regulatory File
Overview
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
4th leading cause of end-stage renal disease (ESRD).
Kidney cyst growth =⇒
increased kidney volume, activation of the RAAS, hypertension, and renal failure. No evidence BP control or RAAS blockade slows the progression of renal disease.
HALT-PKD Trials
Study A: Participants & Trial Design
558 young (15-49 yrs) and healthy (eGFR> 60) participants Randomized in 2x2 design to:
ACE-I + ARB or ACE-I alone
standard (120-130/70-80 mmHg) or low (95-110/60-75 mmHg) BP Study B: Participants & Trial Design
486 slightly older (18-64 yrs) participants with moderately advanced disease (eGFR 20-60).
HALT-PKD Consortium Map
HALT%PKD%Clinical%Catchment%Zones% U. Colorado Mayo CCF Pitt (DCC) Tufts BIDMC U. Kansas EmoryData Coordinating Center
Transition of DCC
DCC originally housed at another institution In 2009, transfered to CRHC-DC
Personnel
PI: Charity Moore, PhD
Co-I & Lead Statistician: Kaleab Abebe, PhD
Lead Research Coordinator: Susan Spillane, RN, CCRP Statisticians: Diane Comer, Jie Li, Elan Cohen
Data Coordinating Center Responsibilities
Aim 1“To serve as the HALT-PKD DCC by collaborating with study
investigators, managing protocol and regulatory compliance, facilitating the transfer of data, and supporting HALT-PKD activities for quality control, endpoint adjudication, and blood pressure management.” Aim 2
“Maintain the Web-based data management system that incorporates data tracking, entry, quality control, and report generation.”
Aim 3
“Conduct interim and final statistical analyses to support the aims of the study including the primary analyses for Study A and Study B.”
electronic System for Data Management (eSYSDM)
Web-based data entry and tracking system; data stored on SQL server Facilitates automatic import of centralized laboratory results
Allows real-time reporting of visit completeness, follow-up tracking, drug dosage, specimen inventory, and blood pressure reports. “On the fly fixes”
During the course of the study, there were 2 major changes the DCC had to make:
Integration of outcome adjudication process into web-based system Creation of an electronic regulatory management system
Outcome Adjudication
1 Overview of HALT-PKD
2 “On the fly fixes”
Outcome Adjudication Master Regulatory File
3 Conclusions
Outcome Adjudication
Overview
All-cause and CV-related hospitalizations are secondary outcomes for both Study A & B.
All AEs reviewed during monthly QC call
Need to adjudicate hospitalization based on discharge summary information
Outcome Adjudication
Hospitalization adjudication portal 1.0
Outcome Adjudication
Outcome Adjudication
Hospitalization adjudication portal 2.0
Outcome Adjudication
Outcome Adjudication
Hospitalization adjudication portal 2.0
Outcome Adjudication
Outcome Adjudication
Hospitalization adjudication portal 2.0
Outcome Adjudication
Outcome Adjudication
Hospitalization adjudication portal 2.0
Master Regulatory File
Overview
In 2012, the need for a centralized Regulatory system was identified. Design and implementation of Sharepoint MRF system was completed while writing the closeout protocol.
Master Regulatory File
Master Regulatory File
SHARED FILES SITE SPECIFIC FILES
Master Regulatory File
Master Regulatory File
Master Regulatory File
Master Regulatory File
Master Regulatory File
Master Regulatory File
Master Regulatory File
Master Regulatory File
Master Regulatory File
Master Regulatory File
1 Overview of HALT-PKD
2 “On the fly fixes” Outcome Adjudication Master Regulatory File
3 Conclusions
Take Home Messages
Hospital Adjudication
Outcomes that require adjudication must have secure, systematic, and reproducible review to ensure the integrity of their results.
Master Regulatory File
Develop a standardized regulatory file system with
guidance/justification for required documentation at the initiation of clinical trial activities
promotes regulatory compliance
educational tool for regulatory-naive coordinators aids in remote monitoring of multi-centered trials
Acknowledgements
Acknowledgements
Susan Spillane, RN, CCRP Diane Comer, Jie Li, Elan Cohen
