building a homegrown data management system: perspectives ... cps 2 - abebe.pdf · building a...

Overview of HALT-PKD “On the fly fixes” Conclusions

Building a Homegrown Data Management System:Perspectives from the HALT-PKD Trials

Kaleab Z. Abebe

Assistant Professor of Medicine, Biostatistics, and Clinical & Translational SciencesCenter for Research on Health Care Data Center

University of Pittsburgh School of Medicine

May 18, 2015

Kaleab Z. Abebe HALT-PKD Clinical Trials


1 Overview of HALT-PKD

2 “On the fly fixes”Outcome AdjudicationMaster Regulatory File

3 Conclusions





3 ConclusionsKaleab Z. Abebe HALT-PKD Clinical Trials


Overview

Autosomal Dominant PolycysticKidney Disease (ADPKD)

4th leading cause of end-stagerenal disease (ESRD).

Kidney cyst growth =⇒increased kidney volume,activation of the RAAS,hypertension, and renal failure.

No evidence BP control or RAASblockade slows the progression ofrenal 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 advanceddisease (eGFR 20-60).

Randomized to:

ACE-I + ARB or ACE-I alone



HALT-PKD Consortium Map

HALT%PKD%Clinical%Catchment%Zones%

U. Colorado

Mayo

CCF

Pitt (DCC)

Tufts

BIDMC

U. Kansas

Emory



Data 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

Systems Analysts: Joe Weiss, Terry Sefcik, Linda Quinn, Shelly Rowe



Data Coordinating Center Responsibilities

Aim 1

“To serve as the HALT-PKD DCC by collaborating with studyinvestigators, managing protocol and regulatory compliance, facilitatingthe transfer of data, and supporting HALT-PKD activities for qualitycontrol, endpoint adjudication, and blood pressure management.”

Aim 2

“Maintain the Web-based data management system that incorporatesdata tracking, entry, quality control, and report generation.”

Aim 3

“Conduct interim and final statistical analyses to support the aims ofthe 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 DCChad to make:

Integration of outcome adjudication process into web-based system

Creation of an electronic regulatory management system



Outcome Adjudication






Overview

All-cause and CV-related hospitalizations are secondary outcomes forboth Study A & B.

All AEs reviewed during monthly QC call

Need to adjudicate hospitalization based on discharge summaryinformation




Hospitalization adjudication portal 1.0




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 completedwhile writing the closeout protocol.

ICH E6 Good Clinical Practice as a guidance for what to include.





SHARED FILES SITE SPECIFIC FILES



Take Home Messages

Hospital Adjudication

Outcomes that require adjudication must have secure, systematic, andreproducible review to ensure the integrity of their results.


Develop a standardized regulatory file system withguidance/justification for required documentation at the initiation ofclinical 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

Joe Weiss, Terry Sefcik, Linda Quinn, Shelly Rowe


building a homegrown data management system: perspectives ... cps 2 - abebe.pdf · building a...

Documents